Status:
TERMINATED
An Extension Study of Oral Ozanimod 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 an extension study to evaluate safety and efficacy of ozanimod 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
- Is not in clinical response or clinical remission after completing 12 weeks in the Induction Studies
- Experience relapse or who complete the Maintenance Study
- Complete a study of ozanimod for Crohn's Disease and meet the criteria for participation
Exclusion
- Has any clinically relevant hepatic, neurological, pulmonary, ophthalmological, endocrine, psychiatric, or other major systemic disease making implementation of the protocol or interpretation of the study difficult or that would put the subject at risk by participating in the study
- Has suspected or diagnosed intra-abdominal or perianal abscess that has not been appropriately treated
- Is receiving treatment with any of the following drugs or interventions: CYP2C8 inducers; Monoamine oxidase inhibitors
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
August 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
854 Patients enrolled
Trial Details
Trial ID
NCT03467958
Start Date
August 24 2018
End Date
October 31 2024
Last Update
September 17 2025
Active Locations (766)
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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