Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (EVOLUTION RMS2)

The study will evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Interferon-beta-1a (Avonex®), once a week intramuscularly in participants with Relapsing Multiple Sclerosis (RMS).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety
Estimated Study Start Date: August 19, 2019
Estimated Primary Completion Date: June 30, 2023
Estimated Study Completion Date: June 30, 2023

Arms:
- Experimental: Evobrutinib + Avonex® matched Placebo: Double-Blinded Period
- Active Comparator: Avonex® + Evobrutinib matched Placebo: Double-Blinded Period
- Experimental: Evobrutinib: Open-Label Extension Period