A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)

NCT05119569 ↗

Phase 2 Active not recruiting 109 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (MRI) in participants with RMS. The safety and pharmacokinetics of fenebrutinib will also be evaluated. Participants will be randomized to receive either fenebrutinib or placebo. This study consists of two parts: Double-blind treatment (DBT) phase and an optional Open-label extension (OLE) phase.

Timeline

Start: 2022-03-01
Primary completion: 2023-03-29
Completion: 2027-06-30

Outcome

Met primary endpoint

registry analysis (superiority test); DBT Phase: Fenebrutinib vs DBT Phase: Placebo; p = 0.0022; Rate Ratio 0.313 (95% CI 0.149 to 0.658); Negative Binomial Regression Model NCT05119569 ↗

paper (69% relative reduction [95% CI 34-85]; p=0·0022). PMID 40683275 ↗

Publications

Bar-Or A, Dufek M, Budincevic H, Drulovic J, Habek M, Hua LH, Weber MS, Thomas P, Napieralski J, Mitzner MC, Ratchford JN, Clayton D, Harp CT, Kuruvilla D, Qi Q, Chen YF, Xu Y, Goodyear A, Oh J; FENopta Study Group. Safety and efficacy of fenebrutinib in relapsing multiple sclerosis (FENopta): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial and open-label extension study. Lancet Neurol. 2025 Aug;24(8):656-666. doi: 10.1016/S1474-4422(25)00174-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fenebrutinib	Small molecule	200 mg	Oral