An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
- Interventional
- Recruiting
- NCT03467958
Contact Information
A Phase 3, Multicenter, Open-Label Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
This is an extension study to evaluate safety and efficacy of ozanimod in 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:
- 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 Criteria:
- 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 within the CYP2C8 inhibitors, inducers and Monoamine oxidase inhibitors
Other protocol-defined inclusion/exclusion criteria apply
Inclusion Criteria:
- 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 Criteria:
- 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 within the CYP2C8 inhibitors, inducers and Monoamine oxidase inhibitors
Other protocol-defined inclusion/exclusion criteria apply