An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Study Overview
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Brief Summary
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This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.

Official Title
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A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: Ozanimod


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com Inclusion Criteria: Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies Experience relapse or who complete the Maintenance Study Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation Exclusion Criteria: Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors Other protocol-defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of oral Ozanimod<br> | Drug: Ozanimod<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a CDAI score of < 150 | The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinicalactivity of CD | Up to 264 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with a simple endoscopy score (SES-CD) decrease from baseline of ≥ 50% |  | Up to 264 Weeks | 
| Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline |  | Up to 264 Weeks | 
| Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 |  | Up to 264 Weeks | 
| Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% |  | Up to 264 Weeks | 
| Proportion of participants with CDAI reduction from baseline of ≥ 70 points |  | Up to 264 Weeks | 
| Change from baseline in CDAI |  | Up to 264 Weeks | 
| Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% |  | Up to 264 Weeks | 
| Proportion of participants with CDAI score of < 150 and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points |  | Up to 264 Weeks | 
| Proportion of participants with average daily abdominal pain score ≤ 1 point and average daily stool frequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline and SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points |  | Up to 264 Weeks | 
| Proportion of participants with SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points |  | Up to 264 Weeks | 
| Proportion of participants with a CDAI score < 150 in participants off corticosteroids |  | Up to 264 Weeks | 
| Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% |  | Up to 264 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease, Crohn Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3204