Bristol Myers Squibb is conducting a Phase 3b Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod. The study is actively enrolling subjects within USA and Canada. Subjects ages 18 to 65 who have had relapsing MS for 5 years or less, and have been treated with < 1 Disease-Modifying Therapy at time of study entry may qualify to participate. For more information on this trial, please refer to BMS Study Connect.
Details of the Study:
- A Phase 3b Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)
- Expecting to enroll (randomize) 250 patients in the United States and Canada
- Key Inclusion criteria:
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- Subject is male or female 18 to 65 years of age (inclusive) at the time of signing of the ICF.
- Subject has a diagnosis of MS according to the 2010 or 2017 Revised McDonald criteria.
- Subjects has ≤ 5 years since time of RMS diagnosis.
- Subject has ≤ 1 approved RMS DMT (Disease-Modifying Therapy) at time of study entry
- Oral Zeposia (ozanimod) has been approved by the FDA and Health Canada for relapsing-remitting MS
- Recruitment is expected to run through 31Dec21
- Expecting ~62 sites (inclusive of USA and CAN) – there are currently ~42 sites that are recruiting; however, additional sites will be recruiting very soon
