Viewing Study NCT01904058

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Ignite Creation Date: 2025-12-24 @ 11:58 PM
Ignite Modification Date: 2026-01-10 @ 2:29 PM
Study NCT ID: NCT01904058
Status: COMPLETED
Last Update Posted: 2019-03-27
First Post: 2013-07-17
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008105', 'term': 'Liver Cirrhosis, Biliary'}], 'ancestors': [{'id': 'D002780', 'term': 'Cholestasis, Intrahepatic'}, {'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@mirumpharma.com', 'phone': '1-650-667-4085', 'title': 'Study Physician', 'organization': 'Mirum'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)', 'description': 'One subject was randomized to LUM001 10 mg, but was down-titrated to 5mg dose due to tolerability issues. One participant was randomized to LUM001 10 mg, but was down-titrated to 5 mg dose due to tolerability issues. The safety data has been summarized based on the study dose actually received by the participant.', 'eventGroups': [{'id': 'EG000', 'title': 'LUM001 5 mg + UDCA', 'description': 'Participants received LUM001 5 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'LUM001 10 mg + UDCA', 'description': 'Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.', 'otherNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'LUM001 20 mg + UDCA', 'description': 'Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.', 'otherNumAtRisk': 21, 'otherNumAffected': 20, 'seriousNumAtRisk': 21, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo + UDCA', 'description': 'Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.', 'otherNumAtRisk': 24, 'otherNumAffected': 16, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 19, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Faeces Discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gingival Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Mouth Ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Anal Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Muscular Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Musculoskeletal Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pain In Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Laryngeal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pharyngeal Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinus Operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 10 mg + UDCA (Cohort A', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '48.11', 'spread': '13.363', 'groupId': 'OG000'}, {'value': '52.10', 'spread': '13.780', 'groupId': 'OG001'}, {'value': '54.64', 'spread': '9.157', 'groupId': 'OG002'}, {'value': '49.46', 'spread': '14.110', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13/ET', 'categories': [{'measurements': [{'value': '-24.59', 'spread': '15.240', 'groupId': 'OG000'}, {'value': '-27.67', 'spread': '19.888', 'groupId': 'OG001'}, {'value': '-26.18', 'spread': '18.313', 'groupId': 'OG002'}, {'value': '-22.77', 'spread': '17.123', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.6603', 'groupIds': ['OG000', 'OG002', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.28', 'ciLowerLimit': '-12.59', 'ciUpperLimit': '8.03', 'pValueComment': 'p-value (LUM001 LS Mean = Placebo LS Mean).', 'groupDescription': 'The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score evaluated by analysis of covariance (ANCOVA) using generalized linear model (GLM). The model included terms for treatment group, alkaline phosphatase (ALP) level (strata), treatment group by ALP level interaction and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95 percentage (%) confidence interval for mean were presented.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'pValue': '0.4380', 'groupIds': ['OG001', 'OG002', 'OG003'], 'paramType': 'Least squares mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.99', 'ciLowerLimit': '-14.20', 'ciUpperLimit': '6.23', 'pValueComment': 'p-value (LUM001 LS Mean = Placebo LS Mean).', 'groupDescription': 'The difference between treatment groups in change from Baseline to Week 13/ET in ItchRO weekly sum score was evaluated by ANCOVA using a GLM. The model included terms for treatment group, ALP level (strata), treatment group by ALP level interaction, and Baseline ItchRO weekly sum score as a covariate. Least squares mean change from Baseline to Week 13/ET, along with 95% confidence interval for the mean, were presented.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 13/ET', 'description': 'Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all participants who were randomized, received at least 1 dose of treatment, and had at least 1 post-baseline ItchRO assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus Using Adult ItchRO Weekly Sum Scores at Weeks 4, 8 and 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'classes': [{'title': 'Baseline (n=21, 21, 11, 13)', 'categories': [{'measurements': [{'value': '48.11', 'spread': '13.363', 'groupId': 'OG000'}, {'value': '52.10', 'spread': '13.780', 'groupId': 'OG001'}, {'value': '54.64', 'spread': '9.157', 'groupId': 'OG002'}, {'value': '49.46', 'spread': '14.110', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4 (n=20, 21, 11, 13)', 'categories': [{'measurements': [{'value': '-15.62', 'spread': '13.708', 'groupId': 'OG000'}, {'value': '-22.19', 'spread': '18.101', 'groupId': 'OG001'}, {'value': '-10.55', 'spread': '11.103', 'groupId': 'OG002'}, {'value': '-16.23', 'spread': '12.749', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 (n=20, 21, 10, 13)', 'categories': [{'measurements': [{'value': '-21.92', 'spread': '13.089', 'groupId': 'OG000'}, {'value': '-23.97', 'spread': '20.398', 'groupId': 'OG001'}, {'value': '-23.50', 'spread': '18.585', 'groupId': 'OG002'}, {'value': '-19.15', 'spread': '15.302', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13 (n=18, 21, 10, 12)', 'categories': [{'measurements': [{'value': '-27.41', 'spread': '14.346', 'groupId': 'OG000'}, {'value': '-27.67', 'spread': '19.888', 'groupId': 'OG001'}, {'value': '-28.50', 'spread': '17.520', 'groupId': 'OG002'}, {'value': '-22.92', 'spread': '17.876', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8 and 13', 'description': 'ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Here, "n" signifies the number of participants evaluable for the respective time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pruritus Using Adult ItchRO Average Daily Scores at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'classes': [{'title': 'Baseline (n=21, 21, 11, 13)', 'categories': [{'measurements': [{'value': '6.873', 'spread': '1.9091', 'groupId': 'OG000'}, {'value': '7.442', 'spread': '1.9686', 'groupId': 'OG001'}, {'value': '7.805', 'spread': '1.3082', 'groupId': 'OG002'}, {'value': '7.066', 'spread': '2.0158', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4 (n=20, 21, 11, 13', 'categories': [{'measurements': [{'value': '-2.231', 'spread': '1.9587', 'groupId': 'OG000'}, {'value': '-3.170', 'spread': '2.5859', 'groupId': 'OG001'}, {'value': '-1.506', 'spread': '1.5861', 'groupId': 'OG002'}, {'value': '-2.319', 'spread': '1.8212', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 (n=20, 21, 10, 13)', 'categories': [{'measurements': [{'value': '-3.131', 'spread': '1.8703', 'groupId': 'OG000'}, {'value': '-3.424', 'spread': '2.9139', 'groupId': 'OG001'}, {'value': '-3.357', 'spread': '2.6549', 'groupId': 'OG002'}, {'value': '-2.736', 'spread': '2.1860', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13 (n=18, 21, 10, 12)', 'categories': [{'measurements': [{'value': '-3.915', 'spread': '2.0496', 'groupId': 'OG000'}, {'value': '-3.952', 'spread': '2.8411', 'groupId': 'OG001'}, {'value': '-4.071', 'spread': '2.5028', 'groupId': 'OG002'}, {'value': '-3.274', 'spread': '2.5537', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13/ET (n=21, 21, 11, 13)', 'categories': [{'measurements': [{'value': '-3.512', 'spread': '2.1774', 'groupId': 'OG000'}, {'value': '-3.952', 'spread': '2.8411', 'groupId': 'OG001'}, {'value': '-3.740', 'spread': '2.6161', 'groupId': 'OG002'}, {'value': '-3.253', 'spread': '2.4461', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)', 'description': 'ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. Adult ItchRO average daily score was the sum of daily scores divided by the number of days adult ItchRO was completed, using the 7 days prior to the reported visit date.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Here, "n" signifies the number of participants evaluable for the respective time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alkaline Phosphatase (ALP) at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'classes': [{'title': 'Baseline (n=21, 21, 11, 13)', 'categories': [{'measurements': [{'value': '288.2', 'spread': '193.91', 'groupId': 'OG000'}, {'value': '257.6', 'spread': '190.38', 'groupId': 'OG001'}, {'value': '253.9', 'spread': '96.83', 'groupId': 'OG002'}, {'value': '274.2', 'spread': '190.85', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4 (n=20, 21, 10, 13)', 'categories': [{'measurements': [{'value': '-22.1', 'spread': '54.94', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '47.76', 'groupId': 'OG001'}, {'value': '20.3', 'spread': '49.68', 'groupId': 'OG002'}, {'value': '-0.7', 'spread': '39.69', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 (n=20, 21, 10, 12', 'categories': [{'measurements': [{'value': '2.6', 'spread': '53.95', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '41.98', 'groupId': 'OG001'}, {'value': '8.8', 'spread': '38.72', 'groupId': 'OG002'}, {'value': '-4.8', 'spread': '55.70', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13 (n=17, 20, 10, 12)', 'categories': [{'measurements': [{'value': '-15.2', 'spread': '97.19', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '56.21', 'groupId': 'OG001'}, {'value': '24.3', 'spread': '76.48', 'groupId': 'OG002'}, {'value': '-7.2', 'spread': '83.70', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13/ET (n=21, 21, 11, 13)', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '93.02', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '55.60', 'groupId': 'OG001'}, {'value': '22.9', 'spread': '72.70', 'groupId': 'OG002'}, {'value': '-7.9', 'spread': '80.19', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline (Week 13/ET)', 'description': 'Laboratory serum ALP enzyme levels were evaluated using blood samples collected.', 'unitOfMeasure': 'units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Here, "n" signifies the number of participants evaluable for the respective time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 5-D Itch Score at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA (Cohort B', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'classes': [{'title': 'Baseline (n=21, 21, 11, 13)', 'categories': [{'measurements': [{'value': '18.7', 'spread': '3.47', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '3.49', 'groupId': 'OG001'}, {'value': '19.6', 'spread': '2.94', 'groupId': 'OG002'}, {'value': '19.2', 'spread': '3.32', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4 (n=20, 21, 10, 13)', 'categories': [{'measurements': [{'value': '-4.8', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '4.96', 'groupId': 'OG001'}, {'value': '-3.4', 'spread': '3.89', 'groupId': 'OG002'}, {'value': '-4.2', 'spread': '3.81', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 (n=20, 21, 10, 12)', 'categories': [{'measurements': [{'value': '-6.8', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '5.62', 'groupId': 'OG001'}, {'value': '-6.4', 'spread': '6.20', 'groupId': 'OG002'}, {'value': '-4.4', 'spread': '4.27', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13 (n=18, 21, 10, 12)', 'categories': [{'measurements': [{'value': '-7.4', 'spread': '3.68', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '5.89', 'groupId': 'OG001'}, {'value': '-7.8', 'spread': '5.94', 'groupId': 'OG002'}, {'value': '-6.1', 'spread': '4.68', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13/ET (n=21, 21, 10, 13)', 'categories': [{'measurements': [{'value': '-6.5', 'spread': '4.11', 'groupId': 'OG000'}, {'value': '-7.0', 'spread': '5.89', 'groupId': 'OG001'}, {'value': '-7.8', 'spread': '5.94', 'groupId': 'OG002'}, {'value': '-5.6', 'spread': '4.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)', 'description': 'The 5-D itch (validated instrument to measure pruritus) scale was developed for the multidimensional quantification of pruritus that is sensitive to change over time. The 5-D itch scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Here, "n" signifies the number of participants evaluable for the respective time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Serum Bile Acid Level at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'classes': [{'title': 'Baseline (n=21, 21, 11, 13)', 'categories': [{'measurements': [{'value': '33.110', 'spread': '30.5943', 'groupId': 'OG000'}, {'value': '52.460', 'spread': '94.3892', 'groupId': 'OG001'}, {'value': '52.615', 'spread': '64.6162', 'groupId': 'OG002'}, {'value': '58.434', 'spread': '73.9895', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4 (n=20, 21, 10, 13)', 'categories': [{'measurements': [{'value': '-11.204', 'spread': '31.6132', 'groupId': 'OG000'}, {'value': '-14.465', 'spread': '58.5891', 'groupId': 'OG001'}, {'value': '-10.221', 'spread': '50.0398', 'groupId': 'OG002'}, {'value': '14.317', 'spread': '75.1092', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 (n=20, 21, 10, 12)', 'categories': [{'measurements': [{'value': '-3.968', 'spread': '45.7388', 'groupId': 'OG000'}, {'value': '-21.983', 'spread': '78.6134', 'groupId': 'OG001'}, {'value': '-3.585', 'spread': '52.4398', 'groupId': 'OG002'}, {'value': '34.893', 'spread': '67.7189', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13 (n=18, 21, 10, 12)', 'categories': [{'measurements': [{'value': '-8.122', 'spread': '48.1290', 'groupId': 'OG000'}, {'value': '-19.098', 'spread': '81.8452', 'groupId': 'OG001'}, {'value': '11.481', 'spread': '44.0465', 'groupId': 'OG002'}, {'value': '4.123', 'spread': '46.2170', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13/ET (n=21, 21, 10, 13)', 'categories': [{'measurements': [{'value': '-4.504', 'spread': '45.7595', 'groupId': 'OG000'}, {'value': '-19.098', 'spread': '81.8452', 'groupId': 'OG001'}, {'value': '11.481', 'spread': '44.0465', 'groupId': 'OG002'}, {'value': '3.690', 'spread': '44.2770', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)', 'description': 'Laboratory serum bile acid level levels were evaluated using blood samples collected.', 'unitOfMeasure': 'micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Here, "n" signifies the number of participants evaluable for the respective time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bile Acid Synthesis as Measured by Serum 7 Alpha-Hydroxy-4-Cholesten-3-One C4 Level [7 Alpha C4]) at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'classes': [{'title': 'Baseline (n=21, 21, 10, 13)', 'categories': [{'measurements': [{'value': '18.74', 'spread': '16.180', 'groupId': 'OG000'}, {'value': '13.17', 'spread': '11.851', 'groupId': 'OG001'}, {'value': '22.31', 'spread': '20.769', 'groupId': 'OG002'}, {'value': '16.98', 'spread': '33.093', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 4 (n=20, 21, 9, 13)', 'categories': [{'measurements': [{'value': '8.66', 'spread': '23.422', 'groupId': 'OG000'}, {'value': '17.03', 'spread': '18.380', 'groupId': 'OG001'}, {'value': '-6.80', 'spread': '6.783', 'groupId': 'OG002'}, {'value': '-0.19', 'spread': '8.856', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 8 (n=20, 21, 9, 12)', 'categories': [{'measurements': [{'value': '13.04', 'spread': '17.895', 'groupId': 'OG000'}, {'value': '15.03', 'spread': '31.120', 'groupId': 'OG001'}, {'value': '-12.57', 'spread': '14.630', 'groupId': 'OG002'}, {'value': '3.43', 'spread': '16.666', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13 (n=18, 21, 9, 12)', 'categories': [{'measurements': [{'value': '24.38', 'spread': '38.105', 'groupId': 'OG000'}, {'value': '6.62', 'spread': '10.116', 'groupId': 'OG001'}, {'value': '-12.72', 'spread': '10.374', 'groupId': 'OG002'}, {'value': '4.56', 'spread': '13.610', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 13/ET (n=21, 21, 9, 13)', 'categories': [{'measurements': [{'value': '20.56', 'spread': '37.312', 'groupId': 'OG000'}, {'value': '6.62', 'spread': '10.116', 'groupId': 'OG001'}, {'value': '-12.72', 'spread': '10.374', 'groupId': 'OG002'}, {'value': '4.74', 'spread': '13.047', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline Visit (Week 13/ET)', 'description': 'C4 7 alpha-hydroxy-4-cholesten-3-one is an intermediate in the biochemical synthesis of bile acids from cholesterol and its concentrations reflect the activity of the bile acid synthetic pathway. Elevated levels of C4 indicate bile acid malabsorption. Laboratory C4 levels were evaluated using blood samples collected.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population. Here, "n" signifies the number of participants evaluable for the respective time points.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LUM001 5 mg + UDCA', 'description': 'Participants received LUM001 5 milligram (mg) tablet orally once daily for a period of 13 weeks in combination with UDCA.'}, {'id': 'OG001', 'title': 'LUM001 10 mg + UDCA', 'description': 'Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.'}, {'id': 'OG002', 'title': 'LUM001 20 mg + UDCA', 'description': 'Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.'}, {'id': 'OG003', 'title': 'Placebo + UDCA', 'description': 'Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)', 'description': 'An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the product. A serious adverse event (SAE) was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect; an important medical event that did not meet any of the above criteria but jeopardized the participant or required medical or surgical intervention to prevent one of the outcomes listed above. A TEAE was defined as any AE that occurred during the study, from the start of investigational product dosing through the end of the study (13 weeks of treatment period (or ET) + 14 days \\]), or that worsened since the start of dosing.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Population included all participants who were randomized and received at least 1 dose of the study drug. One participant was randomized to LUM001 10 mg, but was down-titrated to 5 mg dose due to tolerability issues. The safety data has been summarized based on the study dose actually received by the participant.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'FG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'FG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'FG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted in 24 centers in the United Kingdom, Canada, and the United States between 19 August 2013 and 09 April 2015.', 'preAssignmentDetails': 'A total of 87 participants were screened out of which 66 participants were randomized into the study and the remaining 21 were screen failures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'LUM001 10 mg + UDCA (Cohort A)', 'description': 'In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'BG001', 'title': 'LUM001 20 mg + UDCA (Cohort B)', 'description': 'In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'BG002', 'title': 'Placebo + UDCA (Cohort A)', 'description': 'In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'BG003', 'title': 'Placebo + UDCA (Cohort B)', 'description': 'In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '12.74', 'groupId': 'BG000'}, {'value': '53.5', 'spread': '10.53', 'groupId': 'BG001'}, {'value': '47.5', 'spread': '8.14', 'groupId': 'BG002'}, {'value': '55.8', 'spread': '8.73', 'groupId': 'BG003'}, {'value': '53.3', 'spread': '10.77', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-15', 'studyFirstSubmitDate': '2013-07-17', 'resultsFirstSubmitDate': '2016-04-01', 'studyFirstSubmitQcDate': '2013-07-17', 'lastUpdatePostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-05-24', 'studyFirstPostDateStruct': {'date': '2013-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From the first dose of study drug until the 13 weeks of treatment period (or ET) + 14 days (approximately 15 weeks)', 'description': 'An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the product. A serious adverse event (SAE) was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening; persistent or significant disability/incapacity; congenital anomaly or birth defect; an important medical event that did not meet any of the above criteria but jeopardized the participant or required medical or surgical intervention to prevent one of the outcomes listed above. A TEAE was defined as any AE that occurred during the study, from the start of investigational product dosing through the end of the study (13 weeks of treatment period (or ET) + 14 days \\]), or that worsened since the start of dosing.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Pruritus Using Adult Itch Reported Outcome (ItchRO) Weekly Sum Score at Week 13/ Early Termination (ET)', 'timeFrame': 'Baseline and Week 13/ET', 'description': 'Pruritus was assessed using ItchRO measure, administered as an electronic diary (eDiary) which was completed by the participants twice daily (morning and evening). (ItchRO) scores ranged from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Pruritus Using Adult ItchRO Weekly Sum Scores at Weeks 4, 8 and 13', 'timeFrame': 'Baseline, Weeks 4, 8 and 13', 'description': 'ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. The weekly sum score was calculated as the sum of the daily scores for the 7 days prior to the time point being reported: 7 days prior to randomization or 7 days prior to Week 13/ET visit.'}, {'measure': 'Change From Baseline in Pruritus Using Adult ItchRO Average Daily Scores at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)', 'description': 'ItchRO scores had a range from 0 to 10, with 0 representing no itch and 10 representing very severe itching. The highest score between the morning and evening ItchRO reports represented the daily score: a measure of the worst itching over the previous 24-hour period. Adult ItchRO average daily score was the sum of daily scores divided by the number of days adult ItchRO was completed, using the 7 days prior to the reported visit date.'}, {'measure': 'Change From Baseline in Alkaline Phosphatase (ALP) at Weeks 4, 8, 13, and Last Post-baseline Visit (Week 13/ET)', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline (Week 13/ET)', 'description': 'Laboratory serum ALP enzyme levels were evaluated using blood samples collected.'}, {'measure': 'Change From Baseline in 5-D Itch Score at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)', 'description': 'The 5-D itch (validated instrument to measure pruritus) scale was developed for the multidimensional quantification of pruritus that is sensitive to change over time. The 5-D itch scale included 5 domains (duration, degree, direction, disability, and distribution of pruritus). The total 5-D score was obtained by scoring each of the domains separately and then summing them together. 5-D total scores ranged between 5 (no pruritus) and 25 (most severe pruritus).'}, {'measure': 'Change From Baseline in Fasting Serum Bile Acid Level at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline visit (Week 13/ET)', 'description': 'Laboratory serum bile acid level levels were evaluated using blood samples collected.'}, {'measure': 'Change From Baseline in Bile Acid Synthesis as Measured by Serum 7 Alpha-Hydroxy-4-Cholesten-3-One C4 Level [7 Alpha C4]) at Weeks 4, 8, 13, and Last Post -Baseline Visit (Week 13/ET)', 'timeFrame': 'Baseline, Weeks 4, 8, 13 and Last Post-baseline Visit (Week 13/ET)', 'description': 'C4 7 alpha-hydroxy-4-cholesten-3-one is an intermediate in the biochemical synthesis of bile acids from cholesterol and its concentrations reflect the activity of the bile acid synthetic pathway. Elevated levels of C4 indicate bile acid malabsorption. Laboratory C4 levels were evaluated using blood samples collected.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PBC'], 'conditions': ['PBC', 'Primary Biliary Cirrhosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lumenapharma.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized, double-blind, placebo-controlled, multicenter study. It is a 13-week Phase 2 study in adults with primary biliary cirrhosis designed to compare the effect of daily dosing with UDCA in combination with LUM001 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Primary Biliary Cirrhosis\n2. Moderate to severe pruritus\n3. Taking ursodeoxycholic acid (UDCA) for at least 6 months, or unable to tolerate UDCA\n4. Ability to understand and willingness to sign informed consent prior to initiation of any study procedures\n\nExclusion Criteria:\n\n1. History or presence of other concomitant significant liver disease\n2. Liver transplant\n3. Known HIV infection\n4. Women who are pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01904058', 'acronym': 'CLARITY', 'briefTitle': 'Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirum Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis', 'orgStudyIdInfo': {'id': 'LUM001-201'}, 'secondaryIdInfos': [{'id': '2013-000482-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LUM001 and Ursodeoxycholic Acid (UDCA)', 'description': 'Administered orally once daily', 'interventionNames': ['Drug: LUM001', 'Drug: Ursodeoxycholic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Ursodeoxycholic Acid (UDCA)', 'description': 'Administered orally once daily', 'interventionNames': ['Drug: Placebo', 'Drug: Ursodeoxycholic Acid']}], 'interventions': [{'name': 'LUM001', 'type': 'DRUG', 'armGroupLabels': ['LUM001 and Ursodeoxycholic Acid (UDCA)']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo and Ursodeoxycholic Acid (UDCA)']}, {'name': 'Ursodeoxycholic Acid', 'type': 'DRUG', 'otherNames': ['UDCA'], 'armGroupLabels': ['LUM001 and Ursodeoxycholic Acid (UDCA)', 'Placebo and Ursodeoxycholic Acid (UDCA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 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'55114', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Gastroenterology', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Advanced Liver Therapies at St. Lukes Episcopal Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Health Science Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23602', 'city': 'Newport News', 'state': 'Virginia', 'country': 'United States', 'facility': 'Liver Institute of Virginia', 'geoPoint': {'lat': 36.98038, 'lon': -76.42975}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Hunter Holmes McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network, Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Liverpool & Broadgreen University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Newcastle University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals (John Radcliffe)', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Free Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "Imperial College London St Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mirum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mirum Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}