NCT04032158

Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Evobrutinib	Participants received evobrutinib twice daily (BID).
DRUG	Avonex®	Participants received avonex® IM injection once a week.
DRUG	Avonex® matched Placebo	Participants received IM injection of placebo matched to Avonex® once a week.
DRUG	Evobrutinib matched Placebo	Participants received placebo matched to evobrutinib twice a day.

Timeline

• Start date: 2019-08-26
• Primary completion: 2020-04-16
• Completion: 2020-04-16
• First posted: 2019-07-25
• Last updated: 2021-08-05
• Results posted: 2021-08-05

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study