Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

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.

Timeline

Start

2020-06-12

Primary completion

2023-10-02

Completion

2024-03-08

Outcome

Missed primary endpoint

Stopped: “Primary analysis of the RMS phase 3 study (MS200527\_0080) resulted in the early termination of the study.”

paper adjusted RR 1·02 [0·75-1·39]; p=0·55) in evolutionRMS1 PMID 39307151 ↗

paper The efficacy of evobrutinib was not superior to that of teriflunomide. PMID 39307151 ↗

release “evolutionRMS 1 and evolutionRMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints” emdserono.com ↗

Publications

• Results Montalban X, Vermersch P, Arnold DL, Bar-Or A, Cree BAC, Cross AH, Kubala Havrdova E, Kappos L, Stuve O, Wiendl H, Wolinsky JS, Dahlke F, Le Bolay C, Shen Loo L, Gopalakrishnan S, Hyvert Y, Javor A, Guehring H, Tenenbaum N, Tomic D; evolutionRMS investigators. Safety and efficacy of evobrutinib in relapsing multiple sclerosis (evolutionRMS1 and evolutionRMS2): two multicentre, randomised, double-blind, active-controlled, phase 3 trials. Lancet Neurol. 2024 Nov;23(11):1119-1132. doi: 10.1016/S1474-4422(24)00328-4. Epub 2024 Sep 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evobrutinib	Small molecule	45 mg	Oral
Comparator	Teriflunomide	Small molecule	14 mg	Oral

Indications