protocolSection identificationModule nctId: NCT06290934, orgStudyIdInfo id: GS-US-409-5704, secondaryIdInfos id: 2023-508304-38, type: OTHER, domain: European Medicines Agency, briefTitle: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis, acronym: SWIFT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2027-05, completionDateStruct date: 2028-03, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Gilead Sciences, class: INDUSTRY, descriptionModule briefSummary: The goal of this study is to learn if GS-1427 is effective and safe 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 (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2).The primary objectives of this study are:Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12, conditionsModule conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 423, type: ESTIMATED, armsInterventionsModule interventions name: GS-1427, interventions name: Ustekinumab, interventions name: Placebo-to-match GS-1427, outcomesModule primaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Response at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Clinical Response at Week 24, secondaryOutcomes measure: Parts 1 and 2: Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths., secondaryOutcomes measure: Parts 1 and 2: Incidence of Treatment-emergent Lab Abnormalities, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Clinical Remission at Week 12, secondaryOutcomes measure: Part 1: Proportion of Participants Achieving Clinical Remission at Week 52, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Clinical Remission at Week 24, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Partial Modified Mayo Score Remission at Week 52, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 24, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Mucosal Healing at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Mucosal Healing at Week 24, secondaryOutcomes measure: Parts 1 and 2: Proportion of Participants Achieving Endoscopic Improvement at Week 12, secondaryOutcomes measure: Part 2: Proportion of Participants Achieving Endoscopic Improvement at Week 24, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Om Research LLC, status: RECRUITING, city: Camarillo, state: California, zip: 93010, country: United States, geoPoint lat: 34.21639, lon: -119.0376, locations facility: VVCRD Research, status: RECRUITING, city: Garden Grove, state: California, zip: 92845, country: United States, geoPoint lat: 33.77391, lon: -117.94145, locations facility: Om Research LLC, status: RECRUITING, city: Lancaster, state: California, zip: 93534, country: United States, geoPoint lat: 34.69804, lon: -118.13674, locations facility: United Medical Doctors, status: RECRUITING, city: Murrieta, state: California, zip: 92563, country: United States, geoPoint lat: 33.55391, lon: -117.21392, locations facility: Encore Medical Research. LLC, status: RECRUITING, city: Hollywood, state: Florida, zip: 33021, country: United States, geoPoint lat: 26.0112, lon: -80.14949, locations facility: Encore Medical Research of Weston, LLC, status: RECRUITING, city: Weston, state: Florida, zip: 33331, country: United States, geoPoint lat: 26.10037, lon: -80.39977, locations facility: Clinical Research Institute of Michigan, LLC., status: RECRUITING, city: Chesterfield, state: Michigan, zip: 48047, country: United States, geoPoint lat: 42.66281, lon: -82.84242, locations facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center., status: RECRUITING, city: Wyoming, state: Michigan, zip: 49519, country: United States, geoPoint lat: 42.91336, lon: -85.70531, locations facility: Quality Medical Research, status: RECRUITING, city: Nashville, state: Tennessee, zip: 37211, country: United States, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Southwest Clinical Trials, status: RECRUITING, city: Houston, state: Texas, zip: 77074, country: United States, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Southern Star Research Institute, LLC., status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Tyler Research Institute, LLC., status: RECRUITING, city: Tyler, state: Texas, zip: 75701, country: United States, geoPoint lat: 32.35126, lon: -95.30106, hasResults: False