A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
Condition(s) studied
Investigational drug(s) / intervention(s)
Fenebrutinib: Fenebrutinib will be administered orally.
Placebo: Placebo will be administered orally.
Study 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.
Eligibility
Primary outcome measure(s)
- DBT Phase: New Gadolinium (Gd) - Enhancing T1 Lesion Rate Observed on Magnetic Resonance Imaging (MRI) Scans of the Brain Over 12 Weeks — MRI scans performed at Weeks 4, 8 and 12
Radiologic evaluation for Gd enhancing T1 lesion rate was performed using a standardized MRI protocol at screening, and at Weeks 4, 8, and 12. All MRI scans were read by a centralized reading center for efficacy endpoints. The total number of new Gd-enhancing T1 lesions were calculated as the sum of the individual number of new lesions observed at Weeks 4, 8 and 12. The lesion rate (new lesions per scan) was estimated from a negative binomial regression model for the total number of events and was adjusted for the covariate 'presence or absence of T1 Gd+ lesions on the screening MRI'. Log-transformed number of scans were included in the negative binomial model as an "offset" variable to account for different number of scans.
Trial sites (17)
| Facility | City | Region | Status |
|---|---|---|---|
| Fullerton Neurology and Headache Center | Fullerton | California | |
| Cleveland Clinic Lou Ruvo | Las Vegas | Nevada | |
| 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 | |
| Nemocnice Jihlava, prispevkova organizace | Jihlava | Vyso?ina | |
| Fakultni nemocnice u sv. Anny v Brne | Brno | Czechia | |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 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 |
More Hoffmann-La Roche trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05119569 on ClinicalTrials.gov ↗ ← All trials in the USA