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

Phase 4

Terminated

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Ozanimod

• Registration Number: NCT05369832
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Study Start: 2022-12-16
• Primary Completion: 2025-01-21
• Study Completion: 2025-04-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 139

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2 - Advanced therapy-exposed	Ozanimod	-
Cohort 1 - Advanced therapy-naive	Ozanimod	-

Primary Outcome Measures

Name	Time	Method
Clinical response as measured by modified Mayo score	Up to approximately 26 weeks	Cohort 1 and 2

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with Adverse Events (AEs)	Up to approximately 2 years	Cohort 1 and 2
Proportion of participants who achieve endoscopic response	Up to approximately 26 weeks	Cohort 1 and 2
Proportion of participants who achieve histological improvement	Up to approximately 26 weeks	Cohort 1 and 2
Proportion of participants with IBDQ remission with total score of ≥ 170 points	Up to approximately 26 weeks	Cohort 1 and 2
Clinical remission as measured by modified Mayo score	Up to approximately 26 weeks	Cohort 1 and 2
Proportion of participants with change in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score from baseline	Up to approximately 26 weeks	Cohort 1 and 2
Proportion of participants who achieve endoscopic improvement	Up to approximately 26 weeks	Cohort 1 and 2
Proportion of participants with histo-endoscopic mucosal improvement	Up to approximately 26 weeks	Cohort 2 only
Proportion of participants with AEs of interest (AEI)	Up to approximately 2 years	Cohort 1 and 2
Clinical response by partial Mayo score	Up to approximately 104 weeks	Cohort 1 and 2
Proportion of participants with change in total score (≥ 16 points) of IBDQ response from baseline	Up to approximately 26 weeks	Cohort 1 and 2
Proportion of participants who achieve histological remission	Up to approximately 26 weeks	Cohort 2 only
Proportion of participants with Serious Adverse Events (SAEs)	Up to approximately 2 years	Cohort 1 and 2
Clinical remission by partial Mayo score	Up to approximately 104 weeks	Cohort 1 and 2
Corticosteroid-free clinical remission by partial Mayo	Up to approximately 104 weeks	Cohort 1 and 2
Proportion of participants who achieve endoscopic remission	Up to approximately 26 weeks	Cohort 2 only
Corticosteroid-free clinical remission as measured by modified Mayo score	Up to approximately 26 weeks	Cohort 2 only
Proportion of participants with clinical laboratory abnormalities	Up to approximately 2 years	Cohort 1 and 2
Proportion of participants with AEs leading to discontinuation	Up to approximately 2 years	Cohort 1 and 2

Trial Locations

Locations (85)

Local Institution - 0048; 🇺🇸 Dothan, Alabama, United States

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 - 0162; 🇺🇸 Camarillo, California, United States

Local Institution - 0014; 🇺🇸 Lancaster, California, United States

Local Institution - 0002; 🇺🇸 San Diego, California, United States

Local Institution - 0208; 🇺🇸 San Diego, California, United States

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