Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
- Interventional
- Recruiting
- NCT03440385
Contact Information
Induction Study #2 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
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.
Gender
All
Age Group
18 Years to 75 Years
Accepting Healthy Volunteers?
No
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit: www.BMSStudyConnect.com
Inclusion Criteria:
- Crohn's disease for ≥ 3 months on endoscopy and on histological exam
- Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
- Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
- Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
- Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
Exclusion Criteria:
- Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
- 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
Inclusion Criteria:
- Crohn's disease for ≥ 3 months on endoscopy and on histological exam
- Inadequate response or loss of response to corticosteroids, immunomodulators, and/or biologic therapy
- Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450
- Average daily stool frequency ≥ 4 points and/or an abdominal pain of ≥ 2 points
- Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥ 6 (or SES-CD ≥ 4 in participants with isolated ileal disease)
Exclusion Criteria:
- Diagnosis of ulcerative colitis, indeterminate colitis, radiation colitis, or ischemic colitis, or has strictures with prestenotic dilatation requiring procedural intervention
- 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