Phase III
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
- Study HIC#:2000024563
- Last Updated:04/21/2023
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
- Age18 years - 75 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
Elizabeth Ruggiero
- Phone Number: 1-203-785-4576
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Trial Purpose and Description
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 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