A Placebo Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohns Disease.
- Conditions
- Health Condition 1: K509- Crohns disease, unspecified
- Registration Number
- CTRI/2023/07/054673
- Lead Sponsor
- Celgene International II Sàrl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Subject fulfilled the inclusion criteria at time of entry into the Induction Study(RPC01-3201 or RPC01-3202) and has completed the Week 12 efficacy assessments of the Induction Study.
2. Subject should not have any constraints under local regulations, must provide written
informed consent prior to any study-related procedures, and must have the ability to
comply with the Table of Events.
3. Subject is in clinical response (a reduction from baseline in CDAI of = 100 points or CDAI score of < 150 points) and/or clinical remission (CDAI score of < 150 points) and/or has 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.
4. 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
1. Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
2. Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of participants with a Crohns Disease Activity Index (CDAI) score of less than 150 <br/ ><br>2. Proportion of participants with a Simple Endoscopic Score for Crohns Disease (SES-CD) score decrease from baseline of more than or equal to 50 percentTimepoint: Week 52
- Secondary Outcome Measures
Name Time Method 1. Proportion of participants with CDAI reduction from baseline of less than or equal to 100 points or CDAI score of less than 150 <br/ ><br>2. Proportion of participants with average daily abdominal pain score less than or equal to 1 point & average daily stool frequency less than or equal to 3 points with abdominal pain and stool frequency no worse than baseline <br/ ><br>3. Proportion of participants with a CDAI score less than 150 at Week 52, while remaining corticosteroid-free in the prior 12 weeks <br/ ><br>4. Proportion of participants with a CDAI score of less than 150 in participants with a CDAI score less than 150 at pre-randomizationTimepoint: Week 52