CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 109 enrolled
Drug / intervention
Fenebrutinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05119569
NCT05119569Phase 2Active
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis

Hoffmann-La Roche·interventional·Posted Nov 15, 2021·Updated May 19, 2026

In Brief

A Phase 2 clinical trial evaluating Fenebrutinib and Placebo for Relapsing Multiple Sclerosis. Active but no longer recruiting, targeting 109 participants across 17 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsing Multiple Sclerosis
CountriesBosnia and Herzegovina, Croatia, Czechia, Serbia, Slovakia, United States
Collaborators--

Timeline

Phase 2Active
202220232024202520262027
First PostedNov 15, 2021
Enrollment StartMar 1, 2022
Primary CompletionMar 29, 2023
Study CompletionDec 30, 2026
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.6 years ago

Interventions

Fenebrutinibdrug

Fenebrutinib will be administered orally.

Placebodrug

Placebo will be administered orally.