NCT02975349

A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 267 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this protocol is to find out about the safety and effectiveness of M2951 in participants with relapsing multiple sclerosis. Participants were placed into 1 of 3 groups to receive M2951, placebo or tecfidera for 24 weeks. After 24 weeks, the participants on placebo were given M2951.

Conditions

• Relapsing-remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Evobrutinib	Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.
DRUG	Evobrutinib	Participants received Evobrutinib 25 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 25 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.
DRUG	Evobrutinib	Participants received Evobrutinib 75 mg orally, QD up to Week 48 in active treatment period 1 and BE period received Evobrutinib 75 mg QD orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.
DRUG	Placebo	Placebo were administered for 24 weeks in active treatment period.
DRUG	Tecfidera	Participants received Tecfidera 120 mg twice daily (BID) for first 7 days followed by 240 mg orally, BID up to Week 48 in active treatment period 1 and BE period received Tecfidera 120 mg BID orally from Week 48 of BE period (OLE period Day 1) to Week 336 in OLE period.

Timeline

• Start date: 2017-03-07
• Primary completion: 2018-01-24
• Completion: 2024-04-02
• First posted: 2016-11-29
• Last updated: 2025-05-14
• Results posted: 2021-02-05

Locations

56 sites across 8 countries: Bulgaria, Czechia, Poland, Russia, Serbia, Slovakia, Spain, Ukraine

Regulatory

• FDA-regulated drug study