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

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 4

Conditions: Colitis, Ulcerative

Treatments: Drug: Ozanimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT05369832

IM047-029

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Cohort 1 - Advanced therapy-naive

Experimental group

Treatment:

Drug: Ozanimod

Cohort 2 - Advanced therapy-exposed

Experimental group

Treatment:

Drug: Ozanimod