A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Study Overview
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Brief Summary
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This is a study to demonstrate the effect of oral ozanimod as maintenance therapy in participants with moderately to severely active Crohn's Disease.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: Ozanimod
* Other: Placebo


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: Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study In clinical response and/or clinical remission and/or an average daily stool frequency score ≤ 3 and an average abdominal pain score ≤ 1 with abdominal pain and stool frequency no worse than baseline at Week 12 of the Induction Study Exclusion Criteria: Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ozanimod<br> | Drug: Ozanimod<br>* Specified dose on specified days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<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 Crohn's Disease Activity Index (CDAI) score of < 150 | The Crohn's Disease Activity Index (CDAI) is a composite score that is used to measure the clinical activity of CD | Weekk 52 | 
| Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score of < 150 |  | Week 52 | 
| Proportion of participants with average daily abdominal pain score ≤ 1 point and average daily stoolfrequency ≤ 3 points with abdominal pain and stool frequency no worse than baseline |  | Week 52 | 
| Proportion of participants with a CDAI score < 150 at Week 52, while remaining corticosteroid-free in the prior 12 weeks |  | Week 52 | 
| Proportion of participants with a CDAI score of < 150 in participants with a CDAI score < 150 at pre-randomization |  | Week 52 | 
| Proportion of participants with a CDAI score of < 150 at Week 52 and at ≥ 80% of visits between Week 8 and Week 52, inclusive, in participants with a CDAI score <150 at pre-randomization |  | Week 52 | 
| Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% at Week 52 |  | Week 52 | 
| Histologic improvement based on differences between ozanimod and placebo in histologic diseaseactivity scores (ie, Global Histologic Disease Activity Score [GHAS] changes) |  | Week 52 | 
| Proportion of participants with average daily abdominal pain score ≤ 1 point, with average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD decrease from baseline of ≥ 50% |  | Week 52 | 
| Proportion of participants with CDAI score of < 150 and SES-CD decrease from baseline of ≥ 50% |  | Week 52 | 
| Proportion of participants with average daily abdominal pain score ≤ 1 point, with average daily stoolfrequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline and an SES-CD ≤ 4 points and a SES-CD decrease ≥2 points |  | Week 52 | 
| Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 with SES-CD decrease from baseline of ≥ 50% |  | Week 52 | 
| Proportion of participants with CDAI score < 150 at Week 12 and SES-CD decrease from baseline of ≥50% |  | Week 52 | 
| Proportion of participants with CDAI reduction from baseline of ≥ 70 points |  | Week 52 | 
| Proportion of participants with mucosal healing (SES-CD ≤ 4 points and a SES-CD decrease ≥ 2 points) with histologic improvement by GHAS or Robarts Histologic Index |  | Week 52 | 
| Time to relapse and exclusion of other causes of an increase in disease activity unrelated tounderlying CD (eg, infections, change in medication) |  | Week 52 | 
| Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% |  | Week 52 | 

 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, RPC01-3203