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

Stopped early · Phase 4

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT05369832

Run by

Bristol-Myers Squibb

People needed

139

Starts

2022-12-16

Expected to finish

2025-04-11

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0206 — Chandler, Arizona, United States
• Local Institution - 0216 — Gilbert, Arizona, United States
• Local Institution - 0125 — Sun City, Arizona, United States
• Local Institution - 0195 — Tucson, Arizona, United States
• Local Institution - 0045 — North Little Rock, Arkansas, United States
• Local Institution - 0165 — Apple Valley, California, United States
• Local Institution - 0162 — Camarillo, California, United States
• Local Institution - 0014 — Lancaster, California, United States
• OM Research LLC - Lancaster - ClinEdge - PPDS — Lancaster, California, United States
• Local Institution - 0209 — Los Angeles, California, United States
• Local Institution - 0002 — San Diego, California, United States
• Local Institution - 0208 — San Diego, California, United States
• Local Institution - 0185 — San Jose, California, United States
• Local Institution - 0178 — Littleton, Colorado, United States
• Gastro Florida — Clearwater, Florida, United States
• Local Institution - 0018 — Clearwater, Florida, United States
• Local Institution - 0050 — Homestead, Florida, United States
• Local Institution - 0026 — Lighthouse PT, Florida, United States
• Local Institution - 0167 — Miami, Florida, United States
• Local Institution - 0049 — Miami Lakes, Florida, United States
• Wellness Clinical Research-Miami Florida — Miami Lakes, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Local Institution - 0003 — Naples, Florida, United States
• Local Institution - 0058 — Orange Park, Florida, United States
• Local Institution - 0048 — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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