1. For the mandatory data collection for safety, subjects who enrolled in the Phase 1 studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or investigational product (IP) as applicable per the parent studies are eligible, except for subjects who discontinued during Period 1 of study RPC01-1913.

2. For the optional sparse sampling for PK/PD, subjects must satisfy the following criteria:

1. Subjects in study RPC01-1913 have completed the study at least through Period 2 and completed the 7 ± 2 days postdose follow-up assessments; or subjects in study RPC01-1914 have completed the study through the 7 ± 2 days postdose follow-up.

2. Subjects had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.

3. Subjects must be able to comprehend and provide written informed consent, and must be able to comply with the requirements of the study, including the study visit schedule and other protocol requirements or restrictions.

Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites

What this study is about