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

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

  • Colitis, Ulcerative

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

More Details

Status
Terminated
Sponsor
Bristol-Myers Squibb

Study Contact