Status:
COMPLETED
Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
Lead Sponsor:
Celgene
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com
- 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
- 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
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2023
Estimated Enrollment :
606 Patients enrolled
Trial Details
Trial ID
NCT03440385
Start Date
March 7 2018
End Date
November 21 2023
Last Update
December 5 2024
Active Locations (368)
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1
Local Institution - 202
Scottsdale, Arizona, United States, 85258
2
Ucsd Medical Center
La Jolla, California, United States, 92037
3
Local Institution - 010
Lancaster, California, United States, 93534
4
Southern California Research Institute Medical Group, Inc.
Los Angeles, California, United States, 90045