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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 4, Prospective, Open-label Study of Ozanimod to Explore the Safety, Efficacy, Quality of Life, and Biomarker Response in Participants With Moderate to Severe Ulcerative Colitis in Clinical Practice

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Drug: Ozanimod


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 - Advanced therapy-naive<br> | Drug: Ozanimod<br>* Specified dose on specified days<br>* Other names: BMS-986374;|
| Experimental: Cohort 2 - Advanced therapy-exposed<br> | Drug: Ozanimod<br>* Specified dose on specified days<br>* Other names: BMS-986374;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response as measured by modified Mayo score at Week 12 | Cohort 1 and 2 | Up to approximately 26 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Ozanimod, RPC-1063, Zeposia®, Inflammatory bowel disease