Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT06290934
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-02-16', 'studyFirstSubmitQcDate': '2024-03-01', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants Achieving Clinical Response at Week 12', 'timeFrame': 'Week 12', 'description': 'Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1. The mMCS is a scoring system for assessment of Ulcerative Colitis (UC) activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths.', 'timeFrame': 'First dose date up to 76 weeks plus 28 days'}, {'measure': 'Incidence of Treatment-emergent Lab Abnormalities', 'timeFrame': 'First dose date up to 76 weeks plus 28 days'}, {'measure': 'Proportion of Participants Achieving Clinical Remission at Week 12', 'timeFrame': 'Week 12', 'description': 'Clinical remission is defined as a mMCS of ≤ 2, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability).The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.'}, {'measure': 'Proportion of Participants Achieving Clinical Remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Clinical remission is defined as a mMCS of ≤ 2, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability). The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.'}, {'measure': 'Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12', 'timeFrame': 'Week 12', 'description': 'Histologic-endoscopic mucosal improvement is a composite endpoint that uses different units of measure for histologic and endoscopic activities.Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils \\& eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Histologic-endoscopic mucosal improvement is defined as achieving both Geboes score ≤ 3.1 and endoscopic subscore ≤ 1'}, {'measure': 'Proportion of Participants Achieving Mucosal Healing at Week 12', 'timeFrame': 'Week 12', 'description': 'Mucosal healing is a composite endpoint that uses different units of measure for histologic and endoscopic activities. Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils \\& eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Mucosal healing is defined as achieving both Geboes score ≤ 2B.1 and endoscopic subscore ≤ 1.'}, {'measure': 'Proportion of Participants Achieving Endoscopic Improvement at Week 12', 'timeFrame': 'Week 12', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of ≤ 1. Endoscopic subscore is a part of the modified Mayo Clinic Score which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'To Assess the Efficacy of GS-1427 in Achieving Partial Modified Mayo Clinic Score (mMCS) remission at Week 76', 'timeFrame': 'Week 76'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT06290934', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo.\n\nThe primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.\n* Individuals have UC with minimum disease extent of 15 cm from the anal verge.\n* Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.\n* Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy.\n* Individuals have an inadequate response or loss of response or are intolerant to \\< 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action)\n\nKey Exclusion Criteria:\n\n* Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis.\n* Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.\n* Have any history of exposure to vedolizumab or other integrin antagonists\n* Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT06290934', 'acronym': 'SWIFT', 'briefTitle': 'Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)', 'orgStudyIdInfo': {'id': 'GS-US-409-5704'}, 'secondaryIdInfos': [{'id': '2023-508304-38', 'type': 'OTHER', 'domain': 'European Medicines Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A, Part B, Part C: GS-1427 Dose A', 'description': 'Participants will receive GS-1427 Dose A Day 1 through Week 12 (Part A).\n\nParticipants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part B).\n\nParticipants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 24 weeks (through Week 76).', 'interventionNames': ['Drug: GS-1427']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Part B, Part C: GS-1427 Dose B', 'description': 'Participants will receive GS-1427 Dose B Day 1 through Week 12 (Part A).\n\nParticipants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part B).\n\nParticipants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 24 weeks (through Week 76).', 'interventionNames': ['Drug: GS-1427']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Part B, Part C: GS-1427 Dose C', 'description': 'Participants will receive GS-1427 Dose C Day 1 through Week 12 (Part A).\n\nParticipants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part B).\n\nParticipants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 24 weeks (through Week 76).', 'interventionNames': ['Drug: GS-1427']}, {'type': 'EXPERIMENTAL', 'label': 'Part A, Placebo; Part B, Part C: GS-1427', 'description': 'Participants will receive Placebo to match GS-1427 Day 1 through Week 12 (Part A). Part A placebo participants will be eligible to undergo re-randomization in a double-blind manner after endoscopy assessment at Week 12 to receive one of the GS-1427 dose A, B, or C treatments.\n\nParticipants will be eligible to continue and remain on the new dose through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 24 weeks (through Week 76).', 'interventionNames': ['Drug: GS-1427', 'Drug: Placebo-to-match GS-1427']}], 'interventions': [{'name': 'GS-1427', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part A, Part B, Part C: GS-1427 Dose A', 'Part A, Part B, Part C: GS-1427 Dose B', 'Part A, Part B, Part C: GS-1427 Dose C', 'Part A, Placebo; Part B, Part C: GS-1427']}, {'name': 'Placebo-to-match GS-1427', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Part A, Placebo; Part B, Part C: GS-1427']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Onyx Clinical Research (Clinic Location)', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '93010', 'city': 'Camarillo', 'state': 'California', 'country': 'United States', 'facility': 'Om Research LLC', 'geoPoint': {'lat': 34.21639, 'lon': -119.0376}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'VVCRD Research', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': '310 Clinical Research', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'US San Diego Health System', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Om Research LLC', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "UCSF Benioff Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University Of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'SDG Clinical Research, LLC', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Acclaim Clinical Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Peak Gastroenterology Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80921', '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', 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Care & Research, Inc', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34653', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Alliance Clinical Research of Tampa, LLC', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '32825', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Digestive and Liver Center of Florida, LLC', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34741', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research of Osceola', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33331', 'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Encore Medical Research of Weston, LLC', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'EBGS Clinical Research Center', 'geoPoint': {'lat': 33.85733, 'lon': 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'Wyoming', 'state': 'Michigan', 'country': 'United States', 'facility': 'Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '38655', 'city': 'Oxford', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Gastroenterology Associates of North Mississippi', 'geoPoint': {'lat': 34.3665, 'lon': -89.51925}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Digestive Health Specialists (Clinic Visits)', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '63304', 'city': 'Weldon Spring', 'state': 'Missouri', 'country': 'United States', 'facility': 'St Charles Clinical Research', 'geoPoint': {'lat': 38.71339, 'lon': -90.68929}}, {'zip': '07728', 'city': 'Freehold', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Tandem - Allied Clinical Research, LLC', 'geoPoint': {'lat': 40.26011, 'lon': -74.27376}}, {'zip': '11215', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'N.Y. Total Medical Care, PC', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Long Island Clinical Research Associates', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Lenox Hill Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Grossman School of Medicne', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Research', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '28625', 'city': 'Statesville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Healthcare', 'geoPoint': {'lat': 35.78264, 'lon': -80.8873}}, {'zip': '45440', 'city': 'Beavercreek', 'state': 'Ohio', 'country': 'United States', 'facility': 'Dayton Gastroenterology, LLC', 'geoPoint': {'lat': 39.70923, 'lon': -84.06327}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gastro Health Research', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45801', 'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'facility': 'NexGen Research', 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'country': 'United States', 'facility': 'Gastro Intestinal Research Institute of Northern Ohio, LLC', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '38301', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Skyline gastroenterology of west Tennessee', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '37211', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Quality Medical Research', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Inflammatory Bowel Disease Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78624', 'city': 'Fredericksburg', 'state': 'Texas', 'country': 'United States', 'facility': 'Gastroenterology Research of San Antonio', 'geoPoint': {'lat': 30.2752, 'lon': -98.87198}}, {'zip': '78628', 'city': 'Georgetown', 'state': 'Texas', 'country': 'United States', 'facility': 'Amel Med Llc', 'geoPoint': {'lat': 30.63269, 'lon': -97.67723}}, {'zip': '76063', 'city': 'Mansfield', 'state': 'Texas', 'country': 'United States', 'facility': 'GI Alliance - 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