NCT04338022

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,124 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants with Relapsing Multiple Sclerosis (RMS). Participants who complete the double-blind treatment period (DBTP) and double-blind extension period (DBEP) prior to approval of a separate long-term follow-up study in their country will get an option for evobrutinib treatment continuation through a 96-week open-label extension (OLE) period.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Teriflunomide	Participants received Teriflunomide at a dose of 14 milligrams (mg) orally once daily up to 156 weeks in Double blind treatment period (DBTP) followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in double blind extension (DBE) period and followed by once daily oral doses of Teriflunomide 14 mg up to 96 weeks in open label extension (OLE) period.
DRUG	Evobrutinib	Participants received Evobrutinib at a dose of 45 mg orally twice daily up to 156 weeks in Double blind treatment period (DBTP) followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in double blind extension (DBE) period and followed by twice daily oral doses of Evobrutinib 45 mg up to 96 weeks in open label extension (OLE) period.

Timeline

• Start date: 2020-06-12
• Primary completion: 2023-10-02
• Completion: 2024-03-08
• First posted: 2020-04-08
• Last updated: 2025-06-12
• Results posted: 2025-06-12

Locations

279 sites across 31 countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Canada, Colombia, Croatia, Czechia, Estonia, Finland, France, Georgia, Germany, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russia, Serbia, South Korea, Spain, Taiwan, Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study