Status:
TERMINATED
Induction Study #1 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
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT03440372
Start Date
February 27 2018
End Date
October 1 2024
Last Update
November 4 2025
Active Locations (408)
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1
Holland Center for Family Health
Peoria, Arizona, United States, 85381
2
Local Institution - 026
North Little Rock, Arkansas, United States, 72117
3
Local Institution - 284
Camarillo, California, United States, 93012
4
Local Institution - 165
Chula Vista, California, United States, 91911