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Clinical Trials in the USA / NCT05119569
Active, not recruiting Phase 2

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

NCT05119569 · tracked via the Priya Life Science USA tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2022-03-01
Last updated
2026-08-19

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

FenebrutinibPlacebo

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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: * A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria. * Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening. * For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs. * For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm. Exclusion Criteria: * Disease duration of \> 10 years from the onset of symptoms and an EDSS score at screening \< 2.0. * Female participants who are pregnant or breastfeeding, or intending to become pregnant. * Male participants who intend to father a child during the study. * A diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or non-active Secondary Progressive Multiple Sclerosis (SPMS). * Any known or suspected active infection at screening, including but not limited to a positive screening tests for Hepatitis B and C, an active or latent or inadequately treated infection with tuberculosis (TB), a confirmed or suspected progressive multifocal leukoencephalopathy (PML). * History of cancer including hematologic malignancy and solid tumors within 10 years of screening. * Presence of other neurological disorders that could interfere with the diagnosis of MS or with the assessments of safety or efficacy during the study. * Clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease. * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study. * History of alcohol or other drug abuse within 12 months prior to screening. * History of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of human immunodeficiency virus (HIV) infection. * Inability to complete an MRI scan. * Adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening. * Receipt of a live-attenuated vaccine within 6 weeks prior to randomization. * Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.

Primary outcome measure(s)

Trial sites (17)

FacilityCityRegionStatus
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

Official registry record

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