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First received: March 23, 2023

Clinical Trial: A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis

Study Status: Completed

Recruit Status: RECRUITING

Condition: Relapsing Forms of Multiple Sclerosis

Study Type: INTERVENTIONAL


Official Title: A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumar

Brief Summary: The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2).The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS…

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