A Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (RMS)
Running, not enrolling · Phase 2 · Has a placebo group
Conditions studied: Relapsing Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05119569
- Run by
- Hoffmann-La Roche
- People needed
- 109
- Starts
- 2022-03-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-05-19
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.