Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT03950232
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2019-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000656249', 'term': 'etrasimod'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 896}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT06025227', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-06-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2019-05-13', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Histologic Improvement Assessed by the Geboes, Robarts, and Nancy Histopathology Scores', 'timeFrame': 'Week 52 and Week 104'}, {'measure': 'Percentage of Participants With Histologic Remission Assessed by the Geboes, Robarts, and Nancy Histopathology Scores', 'timeFrame': 'Week 52 and Week 104'}, {'measure': 'Time to Loss of Response Assessed by Mayo Component Sub-scores', 'timeFrame': 'Up to Week 260'}, {'measure': 'Proportion of Participants Achieving Improvement in Extraintestinal Manifestations (EIMs) in Participants With EIMs at Baseline', 'timeFrame': 'Baseline, Week 12, Week 52, Week 104, Week 156, Week 208, and Week 260'}], 'primaryOutcomes': [{'measure': 'Number and Severity of Safety Measures', 'timeFrame': 'Up to approximately 8 years', 'description': 'Safety as assessed by the evaluation of adverse events'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants Achieving Clinical Remission Assessed by Mayo Component Sub-scores', 'timeFrame': 'Week 52 and Week 104'}, {'measure': 'Proportion of Participants Achieving Clinical Remission at Weeks 52 and 104 Among Participants Achieving Clinical Remission at Study Entry', 'timeFrame': 'Week 52 and Week 104'}, {'measure': 'Change From Baseline in the Total Mayo Score', 'timeFrame': 'Baseline, Week 52, and Week 104', 'description': 'The total Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 12 points and consists of 4 components (endoscopic score, rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.'}, {'measure': 'Change From Baseline in Partial Mayo Score', 'timeFrame': 'Baseline, Week 52, Week 104, Week 156, Week 208 and Week 260', 'description': 'The partial Mayo score is a tool designed to measure disease activity for ulcerative colitis. Scoring ranges from 0 to 9 points and consists of 3 non-invasive components (rectal bleeding, stool frequency, and physicians global assessment), each graded 0 to 3 (0 = normal, 1 = mild, 2 = moderate, 3 = severe) with higher score indicating more severe disease.'}, {'measure': 'Proportion of Participants Achieving Endoscopic Improvement Assessed by Mayo Component Sub-scores', 'timeFrame': 'Week 52 and Week 104'}, {'measure': 'Proportion of Participants Achieving Clinical Response Assessed by Mayo Component Sub-scores', 'timeFrame': 'Week 52 and Week 104'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Etrasimod', 'APD334'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '39778975', 'type': 'DERIVED', 'citation': 'Vermeire S, Rubin DT, Peyrin-Biroulet L, Dubinsky MC, Regueiro M, Irving PM, Goetsch M, Lazin K, Gu G, Wu J, Modesto I, McDonnell A, Guo X, Green J, Dalam AB, Yarur AJ. Cardiovascular events observed among patients in the etrasimod clinical programme: an integrated safety analysis of patients with moderately to severely active ulcerative colitis. BMJ Open Gastroenterol. 2025 Jan 8;12(1):e001516. doi: 10.1136/bmjgast-2024-001516.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=APD334-303', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment (either etrasimod 2 mg per day or placebo) during participation in one of the qualified Phase 3 or Phase 2 double-blind, placebo-controlled parent studies including but not limited to: (APD334-301 \\[NCT03945188\\] or APD334-302 \\[NCT03996369\\] or APD334-210 \\[NCT04607837\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have met the eligibility criteria and have been enrolled in the qualified Phase 2 or 3 parent studies listed below or other qualified region-specific studies and meet the following additional criteria:\n\n 1. Participants previously enrolled in Study APD334-301 (NCT03945188) or APD334-210 (NCT04607837) must have completed the Week 12 visit and have been assessed to have active UC that has not improved or has worsened from baseline or completed the Week 52 visit\n 2. Participants previously enrolled in APD334-302 (NCT03996369) must have completed the Week 12 visit\n\nExclusion Criteria:\n\n* If Investigator considers the participant to be unsuitable for any reason to participate in the Open-Label Extension study\n* Experienced an adverse event that led to discontinuation from parent study'}, 'identificationModule': {'nctId': 'NCT03950232', 'acronym': 'ELEVATE UC OLE', 'briefTitle': 'An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'APD334-303'}, 'secondaryIdInfos': [{'id': 'C5041012', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2024-515156-21-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etrasimod 2 mg', 'interventionNames': ['Drug: Etrasimod']}], 'interventions': [{'name': 'Etrasimod', 'type': 'DRUG', 'otherNames': ['APD334'], 'description': "Etrasimod 2 mg tablet by mouth, once daily up to approximately 8 years or until marketing authorization is obtained in the participant's country, whichever comes first", 'armGroupLabels': ['Etrasimod 2 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Center for Digestive Health (Colonoscopy Location)', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36301', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pulmonary Associates (Secondary PFT Location)', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Gut P.C., dba Digestive Health Specialists of the Southeast (IP Address)', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '92532', 'city': 'Lake Elsinore', 'state': 'California', 'country': 'United States', 'facility': 'Inland Pulmonary Specialists [PFT Only]', 'geoPoint': {'lat': 33.66808, 'lon': -117.32726}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'A V Pediatrics,Allergy and Family Medicine', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Endoscopy and Pain Center(Colonoscopy)', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Antelope Valley Eye Care(Ophthalmologist)', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Jatinder S.Pruthi,MD FACG CPI', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Om Research LLC', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Renaissance Imaging Center(Chest X-Ray only)', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '92562', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'United Surgery Center Murrieta [Endoscopy Only]', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'United Medical Doctors', 'geoPoint': {'lat': 33.55391, 'lon': -117.21392}}, {'zip': '93551', 'city': 'Palmdale', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Imaging (Chest X-Ray)', 'geoPoint': {'lat': 34.57943, 'lon': -118.11646}}, {'zip': '92591', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'California Eye Professionals [OCT Only]', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '92592', 'city': 'Temecula', 'state': 'California', 'country': 'United States', 'facility': 'United Surgery Center Temecula [Endoscopy Only]', 'geoPoint': {'lat': 33.49364, 'lon': -117.14836}}, {'zip': '80903', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Front Range Endoscopy Center', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80920', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Peak Gastroenterology Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Bay Area Chest Physicians, P.A.,-(Pulmonary Function Test)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'West Coast Endoscopy Center (Endoscopy Procedures)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Northwood Vision-Optical Coherence Tomography-(OCT)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Safety Harbor Surgery (Endoscopy Facility)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33762', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastro Florida (Regulatory & Administrative Duties)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33762', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Gastro Florida-(Regulatory & Administrative Duties)', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 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'country': 'United States', 'facility': 'LoCicero Medical Group (PFT Procedure Only)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Lyracore Health Alliance (PFT Procedure only)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Newsome Eye Specialist (OCT Procedures Only)', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Health Morsani Center For Advanced Healthcare', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Guardian Angel Research Center, INC', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 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'city': 'Libertyville', 'state': 'Illinois', 'country': 'United States', 'facility': 'Libertyville Imaging Center (Diagnostic Imaging)', 'geoPoint': {'lat': 42.28308, 'lon': -87.95313}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Eye Medical Center (OCT location)', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Baton Rouge LA Endoscopy', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Chevy Chase Pulmonary Associate (PFT Only)', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'Retina Group Of Washington (OCT Only)', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish West County Hospital (Additional Endoscopy Location)', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89113', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Durango Surgical Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Abrams Eye Institute (OCT)', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Lung Center of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27704', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Medical Plaza North Duke Street', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Eye Center (OCT only)', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigational Drug Services (Pharmacy)', 'geoPoint': {'lat': 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'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center Investigational Pharmacy', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'UC Health (Pulmonary Function Testing)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Great Lakes Gastroenterology Research, LLC', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ophthalmic Physicians Incorporated (OCT Only)', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Endoscopy Center of Lake County', 'geoPoint': {'lat': 41.66616, 'lon': -81.33955}}, {'zip': '44060', 'city': 'Mentor', 'state': 'Ohio', 'country': 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