A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy of Fenebrutinib in Relapsing Multiple Sclerosis (FENopta)

  • End date
    Sep 26, 2024
  • participants needed
  • sponsor
    Hoffmann-La Roche
Updated on 27 October 2022


This is a study evaluating the effect of fenebrutinib on brain 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.

Condition Relapsing Multiple Sclerosis
Treatment Placebo, Fenebrutinib
Clinical Study IdentifierNCT05119569
SponsorHoffmann-La Roche
Last Modified on27 October 2022


Yes No Not Sure

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
Known presence of other neurological disorders, 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 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
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