A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) (FENhance)

  • End date
    Nov 27, 2025
  • participants needed
  • sponsor
    Hoffmann-La Roche
Updated on 10 August 2022
Reference Study ID Number: GN41851 https://forpatients.roche.com/
Primary Contact
Advanced Neurology of Colorado, LLC (7.5 mi away) Contact
+105 other location


A study to evaluate the efficacy and safety of fenebrutinib on disability progression and relapse rate in adult participants with RMS. Eligible participants will be randomized 1:1 to either fenebrutinib or teriflunomide. Open-Label Extension (OLE) phase is contingent on a positive benefit-risk result in the Primary Analysis of the study.

Condition Relapsing Multiple Sclerosis
Treatment Placebo, Teriflunomide, Fenebrutinib
Clinical Study IdentifierNCT04586010
SponsorHoffmann-La Roche
Last Modified on10 August 2022


Yes No Not Sure

Inclusion Criteria

Completed the Double-Blind Treatment (DBT) phase of the study (remaining on study treatment; no other Disease-Modifying Therapy (DMT) administered) and who, in the opinion of the investigator, may benefit from treatment with fenebrutinib
Participants randomized to the teriflunomide treatment arm during the DBT phase must undergo the ATEP prior to the first administration of open-label fenebrutinib
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 PPMS or non-active 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
Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
Participants with several renal or hepatic disease impairment or Gilbert's Syndrome
Participants with significantly impaired bone marrow function or significant anemia, leukopenia, neutropenia or thrombocytopenia
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 (inhaled and topical corticosteroids are allowed)
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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