Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
- Registration Number
- NCT03440372
- Lead Sponsor
- Celgene
- Brief Summary
This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 625
- Crohn's disease for ≥ 3 months on endoscopy and on histological exam
- Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapies
- Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
- An average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
- Has Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
- Has a diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
- Has extensive small bowel resection (>100cm) or known diagnosis of short bowel syndrome, or requires total parenteral nutrition
- Current stoma, ileal-anal pouch anastomosis, or fistula
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Administration of oral Ozanimod Ozanimod - Administration of Placebo Placebo -
- Primary Outcome Measures
Name Time Method Proportion of participants with a Crohn's Disease Activity Index (CDAI) score < 150 Week 12
- Secondary Outcome Measures
Name Time Method Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 Week 12 Proportion of participants with CDAI reduction from baseline of ≥ 100 points or CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% Week 12 Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD ≤ 4 points and decrease ≥2 points Week 12 Histologic Improvement based on differences between ozanimod and placebo in histologic disease activity scores (ie, Global Histologic Disease Activity Score changes) Week 12 Proportion of participants with average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points with abdominal pain and stool frequency no worse than baseline Week 12 Proportion of participants with CDAI reduction from baseline of ≥ 70 points Week 12 Proportion of participants with a Simple Endoscopic Score for Crohn's Disease (SES-CD) score decrease from baseline of ≥ 50% Week 12 Proportion of participants with absence of ulcers ≥ 0.5 cm with no segment with any ulcerated surface ≥ 10% Week 12 Proportion of participants with a Crohn's Disease Endoscopic Index of Severity (CDEIS) decrease from baseline of ≥ 50% Week 12 Proportion of participants with CDAI score < 150 and SES-CD decrease from baseline of ≥ 50% Week 12 Proportion of participants with an average daily abdominal pain score ≤ 1 point, and average daily stool frequency score ≤ 3 points and both no worse than baseline AND an SES-CD decrease from baseline of ≥ 50% Week 12
Trial Locations
- Locations (408)
Holland Center for Family Health
🇺🇸Peoria, Arizona, United States
Local Institution - 026
🇺🇸North Little Rock, Arkansas, United States
Local Institution - 284
🇺🇸Camarillo, California, United States
Local Institution - 165
🇺🇸Chula Vista, California, United States
Local Institution - 039
🇺🇸Garden Grove, California, United States
San Diego Clinical Trials
🇺🇸La Mesa, California, United States
Local Institution - 061
🇺🇸Los Angeles, California, United States
Local Institution - 110
🇺🇸Los Angeles, California, United States
Local Institution - 140
🇺🇸Mission Viejo, California, United States
Alliance Clinical Research
🇺🇸Oceanside, California, United States
Scroll for more (398 remaining)Holland Center for Family Health🇺🇸Peoria, Arizona, United States