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RPC01-3204: A PHASE 3, MULTICENTER, OPEN-LABEL EXTENSION STUDY OF ORAL OZANIMOD FOR MODERATELY TO SEVERELY ACTIVE CROHN S DISEASE
Recruiting
This is a Phase 3, open-label, multicenter extension study to evaluate safety and efficacy of ozanimod in subjects with moderately to severely active CD. Approximately 1200 subjects who have previously participated in a study of ozanimod for CD will be eligible to participate in this study if they meet the eligibility criteria as outlined in the prior study (eg, RPC01-3201, RPC01-3202, RPC01-3203, or RPC01-2201).
All
18 Years to 75 Years old
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
• 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
Drug: Ozanimod
Digestive & Liver Health, Crohn Disease
inflammatory bowel disease, Crohn's Disease, Crohn Disease, Oral, Ozanimod, Moderately active, Severely active, RPC01, RPC01-3204, Clinics and Surgery Center (CSC)
Mary McDonald - mcdo0664@umn.edu
Eugenia Shmidt
Phase 3
STUDY00003229
NCT03467958
See this study on ClinicalTrials.gov