Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-01-27 @ 5:32 AM
Study NCT ID:
NCT05643794
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2022-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005356', 'term': 'Fibromyalgia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627812', 'term': 'rozanolixizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'UCBCares@ucb.com', 'phone': '001 844 599 2273', 'title': 'UCB', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline till end of Safety Follow-up (up to Week 33)', 'description': 'TEAE: any AE with start date on or after first dose of IMP in Run-In, and on or before earliest of following: last date of infusion (including Run-Out, if applicable) +56 days, final contact date or death. TEAE also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to treatment. The SS-t included all study participants who received any study treatment, including during Run-In period.', 'eventGroups': [{'id': 'EG000', 'title': 'Run-In-PBO', 'description': 'Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 24, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'TP1-RLZ', 'description': 'Participants received RLZ 560 mg SC in TP1 up to Week 12.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'TP1-PBO', 'description': 'Participants received PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).', 'otherNumAtRisk': 41, 'deathsNumAtRisk': 41, 'otherNumAffected': 37, 'seriousNumAtRisk': 41, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'TP2-RLZ/RLZ', 'description': 'Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'TP2-PBO/RLZ', 'description': 'Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'TP2-PBO/PBO', 'description': 'Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 16, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Run-Out and SFU-RLZ/RLZ', 'description': 'Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Run-Out and SFU-PBO/RLZ', 'description': 'Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 8, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Run-Out and SFU-PBO/PBO', 'description': 'Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 3, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 14, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Abdominal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Irritable bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Catheter site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 14, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Infusion site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, 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{'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 3, 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.'}, {'id': 'OG001', 'title': 'RLZ 12 Weeks', 'description': 'Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.30', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '7.01'}, {'value': '5.76', 'groupId': 'OG001', 'lowerLimit': '5.11', 'upperLimit': '6.41'}]}]}], 'analyses': [{'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.24', 'ciUpperLimit': '0.16', 'estimateComment': 'The difference presented is RLZ 12 weeks minus Placebo.', 'statisticalMethod': 'Longitudinal linear mixed effect model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 12 weeks of treatment', 'description': "The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Run-In-PBO', 'description': 'Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.'}, {'id': 'OG001', 'title': 'TP1-RLZ', 'description': 'Participants received a RLZ 560 mg SC in Treatment Period 1 (TP1) up to Week 12.'}, {'id': 'OG002', 'title': 'TP1-PBO', 'description': 'Participants received a PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).'}, {'id': 'OG003', 'title': 'TP2-RLZ/RLZ', 'description': 'Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.'}, {'id': 'OG004', 'title': 'TP2-PBO/RLZ', 'description': 'Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.'}, {'id': 'OG005', 'title': 'TP2-PBO/PBO', 'description': 'Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.'}, {'id': 'OG006', 'title': 'Run-Out and SFU-RLZ/RLZ', 'description': 'Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.'}, {'id': 'OG007', 'title': 'Run-Out and SFU-PBO/RLZ', 'description': 'Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.'}, {'id': 'OG008', 'title': 'Run-Out and SFU-PBO/PBO', 'description': 'Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}, {'value': '11', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline till end of Safety Follow-up (up to Week 33)', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of investigational medicinal product (IMP) in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death. A TEAE is also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set as treated (SS-t) included all study participants who received any study treatment, including during Run-In period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs Leading to Withdrawal of IMP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '20', 'groupId': 'OG007'}, {'value': '21', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Run-In-PBO', 'description': 'Participants received a PBO SC QW for 2 weeks in Run-In period. All study participants received placebo during the Run-in Period.'}, {'id': 'OG001', 'title': 'TP1-RLZ', 'description': 'Participants received RLZ 560 mg SC in TP1 up to Week 12.'}, {'id': 'OG002', 'title': 'TP1-PBO', 'description': 'Participants received PBO SC QW in TP1 up to Week 12. Pooled data is reported for placebo (Sequence 2 and Sequence 3).'}, {'id': 'OG003', 'title': 'TP2-RLZ/RLZ', 'description': 'Participants who received RLZ in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24. One participant of "TP2-RLZ/RLZ" arm started TP2 but discontinued before receiving IMP.'}, {'id': 'OG004', 'title': 'TP2-PBO/RLZ', 'description': 'Participants who received PBO in TP1 continued RLZ 560 mg SC in Treatment Period 2 (TP2) up to Week 24.'}, {'id': 'OG005', 'title': 'TP2-PBO/PBO', 'description': 'Participants who received PBO in TP1 continued PBO SC in Treatment Period 2 (TP2) up to Week 24.'}, {'id': 'OG006', 'title': 'Run-Out and SFU-RLZ/RLZ', 'description': 'Participants who received RLZ in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had safety-follow-up (SFU), up to 5 weeks.'}, {'id': 'OG007', 'title': 'Run-Out and SFU-PBO/RLZ', 'description': 'Participants who received PBO in TP1 and continued RLZ 560 mg SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.'}, {'id': 'OG008', 'title': 'Run-Out and SFU-PBO/PBO', 'description': 'Participants who received PBO in TP1 and continued PBO SC up to Week 24 in TP2 received placebo SC, QW for 2 weeks in Run-Out period and had SFU, up to 5 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline till end of Safety Follow-up (up to Week 33)', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of IMP in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The SS-t included all study participants who received any study treatment, including during Run-In period.'}, {'type': 'SECONDARY', 'title': 'Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 24 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.'}, {'id': 'OG001', 'title': 'RLZ 24 Weeks', 'description': 'Participants who received 24 weeks of RLZ 560 mg SC treatment during any sequence.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.30', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '7.01'}, {'value': '5.79', 'groupId': 'OG001', 'lowerLimit': '4.97', 'upperLimit': '6.60'}]}]}], 'analyses': [{'pValue': '0.358', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-1.60', 'ciUpperLimit': '0.58', 'estimateComment': 'The difference presented is RLZ 24 weeks minus PBO 24 weeks.', 'statisticalMethod': 'Longitudinal mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 24 weeks of treatment', 'description': "The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference.", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment. Here 'overall number of participants analyzed' signifies participants evaluable for this Outcome measure."}, {'type': 'SECONDARY', 'title': 'Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.'}, {'id': 'OG001', 'title': 'RLZ 12 Weeks', 'description': 'Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.70', 'groupId': 'OG000', 'lowerLimit': '64.90', 'upperLimit': '76.50'}, {'value': '62.30', 'groupId': 'OG001', 'lowerLimit': '57.32', 'upperLimit': '67.28'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.40', 'ciLowerLimit': '-13.84', 'ciUpperLimit': '-2.96', 'estimateComment': 'The difference presented is RLZ 12 weeks minus Placebo', 'statisticalMethod': 'Longitudinal mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 12 weeks of treatment', 'description': 'The Revised Fibromyalgia Impact Questionnaire (FIQR) was a 21-item questionnaire with a recall period of 7 days. The FIQR included 3 domains: activities, overall impact, and symptoms. Each item was based on an 11-point numeric rating scale. The FIQR total score was calculated by taking the sum of the following: Activities domain subtotal divided by 3, overall impact" domain subtotal and symptoms domain subtotal divided by 2. The total score ranged from 0 to 100, with 0 denoting the best possible condition and 100 denoting the worst possible condition. Higher scores indicated more severe impact.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.'}, {'type': 'SECONDARY', 'title': 'Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.'}, {'id': 'OG001', 'title': 'RLZ 12 Weeks', 'description': 'Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.59', 'groupId': 'OG000', 'lowerLimit': '5.96', 'upperLimit': '7.21'}, {'value': '6.63', 'groupId': 'OG001', 'lowerLimit': '6.09', 'upperLimit': '7.18'}]}]}], 'analyses': [{'pValue': '0.878', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Differences from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.55', 'ciUpperLimit': '0.64', 'estimateComment': 'The differences presented is RLZ 12 weeks minus Placebo.', 'statisticalMethod': 'Longitudinal mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 12 Weeks of treatment', 'description': 'The Pain Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much pain have you experienced on average over the past 24 hours?" The 11-point Pain NRS ranged 0 (no pain) to 10 (pain as bad as you can imagine). Mean pain scores were derived the average of the daily assessment over the past 7 days. The higher score represented worst possible pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.'}, {'type': 'SECONDARY', 'title': 'Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo (PBO)', 'description': 'Participants received a PBO SC QW exposure up to 12 weeks and/or extended exposure from 12 to 24 weeks.'}, {'id': 'OG001', 'title': 'RLZ 12 Weeks', 'description': 'Participants who received 12 weeks of RLZ 560 mg SC treatment during any sequence.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.26', 'groupId': 'OG000', 'lowerLimit': '6.66', 'upperLimit': '7.86'}, {'value': '6.98', 'groupId': 'OG001', 'lowerLimit': '6.45', 'upperLimit': '7.51'}]}]}], 'analyses': [{'pValue': '0.352', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference from Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.28', 'ciLowerLimit': '-0.86', 'ciUpperLimit': '0.31', 'estimateComment': 'The difference presented is RLZ 12 weeks minus Placebo.', 'statisticalMethod': 'Longitudinal mixed effects model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 12 weeks of treatment', 'description': 'The Fatigue Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much fatigue have you experienced on average over the past 24 hours?" The 11-point Fatigue NRS ranged 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Mean fatigue scores were derived the average of the daily assessment over the past 7 days. Higher score represented worst possible fatigue.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all study participants who received any study treatment, including during the run-in period, had a baseline value and at least one post-baseline efficacy endpoint assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1: RLZ 12w + RLZ 12w', 'description': 'Participants received placebo, subcutaneously (SC), once weekly (QW) for 2 weeks (Run-in Period), then rozanolixizumab (RLZ) 560 milligrams (mg), SC, QW, weekly (w) for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The safety follow-up (SFU) included all the participants who received the investigational medicinal product (IMP), regardless of discontinuation.'}, {'id': 'FG001', 'title': 'Sequence 2: PBO + RLZ 12w', 'description': 'Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 12 weeks (Treatment Period 1), followed by rozanolixizumab 560 mg, SC, QW for 12 weeks (Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The SFU included all the participants who received the IMP, regardless of discontinuation.'}, {'id': 'FG002', 'title': 'Sequence 3: PBO + PBO', 'description': 'Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Run-out Period). The SFU included all the participants who received the IMP, regardless of discontinuation.'}], 'periods': [{'title': 'Run-In (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 1 (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Consent Withdrawn by Study Participant (Not Due to Adverse Event)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Consent Withdrawn by Study Participant (Not Due to Adverse Event)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'New Work Commitments', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Run-Out Period (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Safety Follow-up Period (5 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The SFU included all the participants who received the IMP at any point in the study, regardless of treatment discontinuation.', 'groupId': 'FG000', 'numSubjects': '22'}, {'comment': 'The SFU included all the participants who received the IMP at any point in the study, regardless of treatment discontinuation.', 'groupId': 'FG001', 'numSubjects': '20'}, {'comment': 'The SFU included all the participants who received the IMP at any point in the study, regardless of treatment discontinuation.', 'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study started to enroll participants in December 2022 and concluded in July 2024.', 'preAssignmentDetails': 'The Participant Flow refers to the Randomized Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence 1: RLZ 12w + RLZ 12w', 'description': 'Participants received placebo, subcutaneously (SC), once weekly (QW) for 2 weeks (Run-in Period), then rozanolixizumab (RLZ) 560 milligrams (mg), SC, QW, weekly (w) for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The safety follow-up (SFU) included all the participants who received the investigational medicinal product (IMP), regardless of discontinuation.'}, {'id': 'BG001', 'title': 'Sequence 2: PBO + RLZ 12w', 'description': 'Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 12 weeks (Treatment Period 1), followed by rozanolixizumab 560 mg, SC, QW for 12 weeks (Treatment Period 2), followed by placebo SC, QW for 2 weeks (Runout Period). The SFU included all the participants who received the IMP, regardless of discontinuation.'}, {'id': 'BG002', 'title': 'Sequence 3: PBO + PBO', 'description': 'Participants received placebo SC, QW for 2 weeks (Run-in Period), then placebo SC, QW for 24 weeks (Treatment Period 1 + Treatment Period 2), followed by placebo SC, QW for 2 weeks (Run-out Period). The SFU included all the participants who received the IMP, regardless of discontinuation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '47.3', 'spread': '9.5', 'groupId': 'BG002'}, {'value': '47.1', 'spread': '9.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Randomized Set (RS) included all enrolled participants who were randomized into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-14', 'size': 2407102, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-16T08:57', 'hasProtocol': True}, {'date': '2024-04-30', 'size': 1886373, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-16T08:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2022-11-30', 'resultsFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2022-11-30', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-26', 'studyFirstPostDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 12 Weeks of Treatment', 'timeFrame': 'At 12 weeks of treatment', 'description': "The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study', 'timeFrame': 'From Baseline till end of Safety Follow-up (up to Week 33)', 'description': 'An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of investigational medicinal product (IMP) in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death. A TEAE is also defined as any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment.'}, {'measure': 'Number of Participants With TEAEs Leading to Withdrawal of IMP', 'timeFrame': 'From Baseline till end of Safety Follow-up (up to Week 33)', 'description': 'An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. A TEAE was defined as any AE with an onset date on or after the first dose of IMP in Run-In and on or before the earliest of the following: the last date of infusion (including Run-Out) +56 days, final contact date, or death.'}, {'measure': 'Brief Pain Inventory Short Form (BPI-SF) Average Interference Score at 24 Weeks of Treatment', 'timeFrame': 'At 24 weeks of treatment', 'description': "The BPI-SF was a self-administered questionnaire used to evaluate the severity of a study participant's pain and the impact of this pain on the study participant's daily functioning. The BPI-SF assesses for the location of pain, pain intensity and functional interference from pain. The 7 BPI-SF interference items included: general activity, mood, walking ability, normal work (including housework), relations with other people, sleep, and enjoyment of life. Each item was rated on a 0 (did not interfere) to 10 (completely interfere) scale with a recall period of 24 hours. The BPI-SF interference score ranges 0-70. Higher scores indicated greater interference."}, {'measure': 'Revised Fibromyalgia Impact Questionnaire (FIQR) Score at 12 Weeks of Treatment', 'timeFrame': 'At 12 weeks of treatment', 'description': 'The Revised Fibromyalgia Impact Questionnaire (FIQR) was a 21-item questionnaire with a recall period of 7 days. The FIQR included 3 domains: activities, overall impact, and symptoms. Each item was based on an 11-point numeric rating scale. The FIQR total score was calculated by taking the sum of the following: Activities domain subtotal divided by 3, overall impact" domain subtotal and symptoms domain subtotal divided by 2. The total score ranged from 0 to 100, with 0 denoting the best possible condition and 100 denoting the worst possible condition. Higher scores indicated more severe impact.'}, {'measure': 'Mean 7-day Average Daily Pain Score Assessed With Pain Numeric Rating Scale (NRS) at 12 Weeks of Treatment', 'timeFrame': 'At 12 Weeks of treatment', 'description': 'The Pain Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much pain have you experienced on average over the past 24 hours?" The 11-point Pain NRS ranged 0 (no pain) to 10 (pain as bad as you can imagine). Mean pain scores were derived the average of the daily assessment over the past 7 days. The higher score represented worst possible pain.'}, {'measure': 'Mean 7-day Fatigue Score Assessed With Fatigue Numeric Rating Scale at 12 Weeks of Treatment', 'timeFrame': 'At 12 weeks of treatment', 'description': 'The Fatigue Numeric Rating Scale (NRS) was a scale in which a respondent selected a whole number that best described "How much fatigue have you experienced on average over the past 24 hours?" The 11-point Fatigue NRS ranged 0 (no fatigue) to 10 (fatigue as bad as you can imagine). Mean fatigue scores were derived the average of the daily assessment over the past 7 days. Higher score represented worst possible fatigue.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Phase 2', 'Fibromyalgia', 'rozanolixizumab'], 'conditions': ['Fibromyalgia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate efficacy and safety of rozanolixizumab to treat adult study participants with severe fibromyalgia syndrome (FMS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Study participant must be ≥18 years and ≤70 years of age at the time of signing the informed consent form (ICF)\n* Study participant with a diagnosis of fibromyalgia as defined by the 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria (American College of Rheumatology Preliminary\n\nDiagnostic Criteria) plus the following characteristics during the Screening Period:\n\n1. Brief Pain Inventory-short form (BPI-SF) interference score ≥6.\n2. Study participant has been diagnosed with fibromyalgia syndrome (FMS) for at least 6 months.\n3. Study participant has been having FMS symptomatology for at least 2 years before enrollment - Capable of giving signed informed consent as described in the Protocol which includes compliance with the requirements and restrictions listed in the ICF and in the Study Protocol\n\nExclusion Criteria:\n\n* Study participant has been diagnosed with fibromyalgia syndrome (FMS) for \\>15 years\n* Study participant has any systemic autoimmune inflammatory disease\n* Study participant has any medical or psychiatric or separate chronic pain condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study or the ability to assess FMS-related pain\n* Study participant has severe renal impairment, defined as estimated glomerular filtration rate \\<30 mL/min/1.73 m\\^2, (calculated using Modification of Diet in Renal Disease \\[MDRD\\] study equation), at Screening visit\n* Study participant has a clinically important active infection (including unresolved or not adequately treated infection) as assessed by the investigator\n* Study participant has chronic inflammatory demyelinating polyneuropathy\n* Study participant has a current or medical history of primary immunodeficiency\n* Study participant is pregnant or lactating\n* Study participant\n\n * Has suicide attempt in the past 2 years (including an active attempt, interrupted attempt, or aborted attempt),\n * OR had suicidal ideation with at least some intent to act in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening or Baseline (Visit 3);\n * OR is otherwise judged clinically to be at a serious suicidal risk based on the investigator's judgment"}, 'identificationModule': {'nctId': 'NCT05643794', 'briefTitle': 'A Proof-of-concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2A, Proof-Of-Concept Study to Evaluate the Efficacy and Safety of Rozanolixizumab to Treat Adult Study Participants With Severe Fibromyalgia Syndrome', 'orgStudyIdInfo': {'id': 'FM0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 1', 'description': 'Study participants on Treatment sequence 1 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.', 'interventionNames': ['Drug: rozanolixizumab', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment sequence 2', 'description': 'Study participants on Treatment sequence 2 will receive rozanolixizumab and Placebo during the dosing period at pre-specified timepoints.', 'interventionNames': ['Drug: rozanolixizumab', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment sequence 3', 'description': 'Study participants on Treatment sequence 3 will receive Placebo during the dosing period at pre-specified timepoints.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'rozanolixizumab', 'type': 'DRUG', 'otherNames': ['UCB7665'], 'description': 'Study participants will receive rozanolixizumab during the dosing periods as pre-defined.', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['PBO'], 'description': 'Study participants will receive Placebo during the dosing periods as pre-defined.', 'armGroupLabels': ['Treatment sequence 1', 'Treatment sequence 2', 'Treatment sequence 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Fm0001 4405', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'city': 'Cannock', 'country': 'United Kingdom', 'facility': 'Fm0001 4406', 'geoPoint': {'lat': 52.69045, 'lon': -2.03085}}, {'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Fm0001 4407', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Fm0001 4404', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Fm0001 4402', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Stockton-on-Tees', 'country': 'United Kingdom', 'facility': 'Fm0001 4403', 'geoPoint': {'lat': 54.56848, 'lon': -1.3187}}, {'city': 'Tankersley', 'country': 'United Kingdom', 'facility': 'Fm0001 4401', 'geoPoint': {'lat': 53.49096, 'lon': -1.48697}}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '001 844 599 2273 (UCB)'}]}, 'ipdSharingStatementModule': {'url': 'http://www.vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.', 'ipdSharing': 'YES', 'description': 'Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.', 'accessCriteria': 'Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}