Status:
TERMINATED
A Placebo-Controlled Study of Oral Ozanimod as Maintenance 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 demonstrate the effect of oral ozanimod as maintenance therapy in 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
- Fulfilled the inclusion criteria at time of entry into the induction study and completed the week 12 efficacy assessments of the induction study
- 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
Exclusion
- Partial or total colectomy, small bowel resection, or an ostomy since day 1 of the induction studies or has developed a symptomatic fistula
- Had a rectal steroid therapy, rectal 5-aminosalicylates, parenteral corticosteroids, immunomodulatory agents, investigational agents or apheresis
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
June 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT03464097
Start Date
June 27 2018
End Date
October 3 2024
Last Update
October 9 2025
Active Locations (765)
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1
Holland Center for Family Health
Peoria, Arizona, United States, 85381
2
Local Institution - 202
Scottsdale, Arizona, United States, 85258
3
Local Institution - 026
North Little Rock, Arkansas, United States, 72117
4
Local Institution - 284
Camarillo, California, United States, 93012