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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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: i) 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

Exclusion Criteria

  • Current or recent (within 3 months of screening) evidence of fulminant colitis, toxic megacolon, or bowel perforation - Extensive colonic resection or current stoma - Colonic dysplasia that has not been removed Other protocol-defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1 - Advanced therapy-naive
  • Drug: Ozanimod
    Specified dose on specified days
    Other names:
    • Zeposia®
    • RPC-1063
    • BMS-986374
Experimental
Cohort 2 - Advanced therapy-exposed
  • Drug: Ozanimod
    Specified dose on specified days
    Other names:
    • Zeposia®
    • RPC-1063
    • BMS-986374

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160-8500
Contact:
Shadi Hamdeh, Site 0192
913-588-6019

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.