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NCT05369832TerminatedPhase 4

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice

Source: ClinicalTrials.gov · Last updated 10 Feb 2026

Reason given: Business objectives have changed.

Brief summary (registry, in English)

The purpose of this study is to explore the safety, efficacy, effects on quality of life (QOL), and biomarker response of ozanimod in participants with moderate to severely active ulcerative colitis (UC) in clinical practice.

Status (registry)
Terminated
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
139 (actual)
First submitted
6 May 2022
Start date
16 Dec 2022
Primary completion date
21 Jan 2025
Lead sponsor
Bristol-Myers Squibb
NCT number
NCT05369832

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Extensive colonic resection or current stoma

Other illness

  • Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation

Other

  • Colonic dysplasia that has not been removed
    • Other protocol-defined inclusion/exclusion criteria apply

Who the study is looking for

  • A diagnosis of ulcerative colitis (UC), with signs and symptoms consistent with UC for at least 3 months prior to the first study intervention administration
  • Moderate to severely active UC disease activity, defined as a modified Mayo score of 4 through 9, inclusive, with the following minimum subscores:
    • An SF subscore ≥ 1, AND ii) An RB subscore ≥ 1, AND iii) An ES ≥ 2 (endoscopy performed within 60 days of the first study intervention administration).
  • Report of a previous colonoscopy that documents extent of disease

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (85)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-Apple ValleyUnited StatesUnknown status
-Arlington HeightsUnited StatesUnknown status
-Baton RougeUnited StatesUnknown status
-BellaireUnited StatesUnknown status
Novel Research LLCBellaireUnited StatesUnknown status
-BostonUnited StatesUnknown status
-BrooklynUnited StatesUnknown status
-CamarilloUnited StatesUnknown status
-ChandlerUnited StatesUnknown status
-ChesterfieldUnited StatesUnknown status
-Chevy ChaseUnited StatesUnknown status
-ChicagoUnited StatesUnknown status
-CincinnatiUnited StatesUnknown status
University of Cincinnati Physicians CompanyCincinnatiUnited StatesUnknown status
Gastro FloridaClearwaterUnited StatesUnknown status
-ClearwaterUnited StatesUnknown status
-ColumbusUnited StatesUnknown status
-CordovaUnited StatesUnknown status
-DallasUnited StatesUnknown status
-DothanUnited StatesUnknown status
-EnglewoodUnited StatesUnknown status
-GilbertUnited StatesUnknown status
-Glen BurnieUnited StatesUnknown status
Carolina Digestive DiseasesGreenvilleUnited StatesUnknown status
-GurneeUnited StatesUnknown status
-HomesteadUnited StatesUnknown status
-HoustonUnited StatesUnknown status
-HoustonUnited StatesUnknown status
Ace Clinical Research Group: Digestive Health AssociatesHoustonUnited StatesUnknown status
-HoustonUnited StatesUnknown status
Houston Methodist HospitalHoustonUnited StatesUnknown status
-Kansas CityUnited StatesUnknown status
-KatyUnited StatesUnknown status
OM Research LLC - Lancaster - ClinEdge - PPDSLancasterUnited StatesUnknown status
-LancasterUnited StatesUnknown status
-Lighthouse PTUnited StatesUnknown status
-LittletonUnited StatesUnknown status
-Los AngelesUnited StatesUnknown status
-LouisvilleUnited StatesUnknown status
-LubbockUnited StatesUnknown status
-LynchburgUnited StatesUnknown status
-MadisonUnited StatesUnknown status
University of Wisconsin Hospital and ClinicsMadisonUnited StatesUnknown status
GI Alliance: Mansfield - TDDCMansfieldUnited StatesUnknown status
-MansfieldUnited StatesUnknown status
-MentorUnited StatesUnknown status
-MiamiUnited StatesUnknown status
-Miami LakesUnited StatesUnknown status
Wellness Clinical Research-Miami FloridaMiami LakesUnited StatesUnknown status
Gastroenterology Group of NaplesNaplesUnited StatesUnknown status
-NaplesUnited StatesUnknown status
-NashvilleUnited StatesUnknown status
-New YorkUnited StatesUnknown status
NYU Langone Health -Inflammatory Bowel Disease CenterNew YorkUnited StatesUnknown status
-New YorkUnited StatesUnknown status
-New YorkUnited StatesUnknown status
-North Little RockUnited StatesUnknown status
-Ocean SpringsUnited StatesUnknown status
-OgdenUnited StatesUnknown status
-Orange ParkUnited StatesUnknown status
-OrlandoUnited StatesUnknown status
-Palm HarborUnited StatesUnknown status
-PlymouthUnited StatesUnknown status
-ProvidenceUnited StatesUnknown status
-RoswellUnited StatesUnknown status
-Salt Lake CityUnited StatesUnknown status
-San AntonioUnited StatesUnknown status
-San AntonioUnited StatesUnknown status
San Antonio GastroenterologySan AntonioUnited StatesUnknown status
-San DiegoUnited StatesUnknown status
-San DiegoUnited StatesUnknown status
-San JoseUnited StatesUnknown status
-San MarcosUnited StatesUnknown status
-SeattleUnited StatesUnknown status
-Sun CityUnited StatesUnknown status
-TacomaUnited StatesUnknown status
-TopekaUnited StatesUnknown status
-TucsonUnited StatesUnknown status
-TylerUnited StatesUnknown status
Tyler Research Institute, LLCTylerUnited StatesUnknown status
-UticaUnited StatesUnknown status
-WebsterUnited StatesUnknown status
-Weldon SpringUnited StatesUnknown status
-WellingtonUnited StatesUnknown status
-WorcesterUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.