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A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
Sponsor: Hoffmann-La Roche
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
109
Start Date
2022-03-01
Completion Date
2026-12-30
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
Fenebrutinib
Fenebrutinib will be administered orally.
Placebo
Placebo will be administered orally.
Locations (17)
Fullerton Neurology and Headache Center
Fullerton, California, United States
Cleveland Clinic Lou Ruvo
Las Vegas, Nevada, United States
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
Clinical Hospital Center Rijeka - PPDS
Rijeka, Croatia
General Hospital Varazdin
Varaždin, Croatia
Klinicki bolnicki centar Zagreb
Zagreb, Croatia
Poliklinika Solmed
Zagreb, Croatia
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia
Nemocnice Jihlava
Jihlava, Czechia
Vseobecna Fakultni Nemocnice V Praze - CRC - PPDS
Prague, Czechia
Clinical Center of Serbia
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Clinical center Kragujevac
Kragujevac, Serbia
Clinical Center Nis
Niš, Serbia
Clinical Hospital Centre Zemun
Zemun, Serbia
Univerzitna nemocnica Bratislava
Bratislava, Slovakia