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Capital Digestive Care | Chevy Chase Clinical Research

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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Enrolling
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

415 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)

415 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

Trial contacts and locations

80

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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