Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
Study NCT ID:
NCT05471492
Status:
WITHDRAWN
Last Update Posted:
2023-10-19
First Post:
2022-07-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D000742', 'term': 'Anemia, Dyserythropoietic, Congenital'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to one of two groups in parallel for the duration of the study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Trial not started; change in Sponsor, a new trial to be registered by the new Sponsor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-17', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-20', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with endoscopic response 50', 'timeFrame': 'Week 14', 'description': "Endoscopy response 50 (SES-CD50) is defined as a reduction from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) at least 50% or more. SES-CD score assesses the presence of ulcers, the percentage of ulcerated surface, the percentage of affected surface, and the presence of narrowing using scales ranging from 0 to 3 in each following bowel segment: Ileum, right colon, transverse colon, left colon, rectum. The score ranges from 0 to 60 with higher score indicating more severe disease."}], 'secondaryOutcomes': [{'measure': "Proportion of participants with a Crohn's Disease Activity Index (CDAI) clinical remission", 'timeFrame': 'Week 14', 'description': 'Clinical remission is defined as CDAI \\< 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.'}, {'measure': 'Proportion of participants achieving endoscopic remission', 'timeFrame': 'Week 14', 'description': 'Endoscopic remission is defined as SES-CD \\< 4 and at least 2-point reduction versus Baseline and no individual subscore \\> 1'}, {'measure': 'Proportion of participants achieving endoscopic mucosal healing', 'timeFrame': 'Week 14', 'description': 'Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD'}, {'measure': 'The proportion of participants with Inflammatory Bowel Disease Questioners (IBDQ) total score ≥170', 'timeFrame': 'Week 14', 'description': 'Inflammatory Bowel Disease Questionnaire (IBDQ) score ranges from 32 to 224. A higher score indicates better quality of life. A score of at least 170 corresponds to clinical remission.'}, {'measure': 'Proportion of participants achieving endoscopic response', 'timeFrame': 'Week 52', 'description': 'Endoscopic response defined as improvement of SES-CD score at least 50% from baseline'}, {'measure': 'Proportion of participants with a CDAI clinical remission', 'timeFrame': 'Week 52', 'description': 'Clinical remission is defined as CDAI \\< 150. CDAI is a composite index consisting of weighted scoring of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.'}, {'measure': 'Proportion of participants achieving endoscopic remission', 'timeFrame': 'Week 52', 'description': 'Endoscopic remission is defined as SES-CD \\< 4 and at least 2-point reduction versus Baseline and no individual subscore \\> 1'}, {'measure': 'Proportion of participants achieving endoscopic mucosal healing', 'timeFrame': 'Week 52', 'description': 'Endoscopic mucosal healing defined as complete absence of ulcers in SES-CD'}, {'measure': 'Proportion of participants with a CDAI clinical remission', 'timeFrame': 'up to week 52', 'description': 'CDAI \\< 150 overtime during induction treatment period'}, {'measure': 'Proportion of participants with a CDAI clinical response', 'timeFrame': 'Up to week 52', 'description': 'As defined by a decrease from baseline in CDAI score of at least 100 points or more'}, {'measure': 'Proportion of participants achieving Patient Reported Outcome 2 (PRO2) clinical response', 'timeFrame': 'Up to week 52', 'description': 'PRO2 clinical response is define by improvement in number of liquid/soft stool frequency and abdominal pain score at least 30% from baseline'}, {'measure': 'Proportion of participants achieving PRO2 clinical remission', 'timeFrame': 'Up to week 52', 'description': 'PRO2 clinical remission is defined as SF≤2.5 and AP≤1'}, {'measure': 'Incidence of AEs or SAEs including events leading to withdrawal due to abnormalities in laboratory, vital signs, and ECG.', 'timeFrame': 'up to week 52'}, {'measure': 'Incidence of development of severe and serious infections', 'timeFrame': 'Up to week 52'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Crohn Disease, PF-06480605, SES-CD, CDAI,'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B7541009', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to characterize safety, efficacy, pharmacokinetics, and immunogenicity"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of ileocolonic or colonic CD with at least 3 months or longer prior to the baseline;\n* Central read total SES-CD score of ≥7. For isolated ileal disease, SES-CD total score should be ≥4;\n* An average daily liquid/very soft SF ≥4 or daily AP score ≥2.0;\n* CDAI between 220 and 450 inclusive;\n* Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for CD\n\nExclusion Criteria:\n\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease, UC, or clinical findings suggestive of UC;\n* Presence of active (draining) fistulae or intra-abdominal or perineal abscesses;\n* Strictures or stenosis with obstructive symptoms;\n* Short bowel syndrome;\n* History of bowel perforation requiring surgical intervention within the past 12 months prior to baseline;\n* Previous bowel surgery resulting in an existing stoma. Participants who have a j-pouch are excluded, as a j-pouch can result in a stoma;\n* History of bowel surgery within 6 months prior to baseline.'}, 'identificationModule': {'nctId': 'NCT05471492', 'briefTitle': "Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Telavant, Inc.'}, 'officialTitle': "A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN LABEL CHRONIC TREATMENT PERIOD TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE CROHN'S DISEASE", 'orgStudyIdInfo': {'id': 'B7541009'}, 'secondaryIdInfos': [{'id': '2022-001259-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1', 'description': 'PF-06480605 150 mg', 'interventionNames': ['Drug: Investigational Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment Group 2', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Investigational Product', 'type': 'DRUG', 'description': 'PF-06480605 150 mg', 'armGroupLabels': ['Treatment Group 1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Treatment Group 2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Telavant, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}