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

• Status: Recruiting
• Trial end date: 2025-11-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Teriflunomide

Criteria

Inclusion Criteria:

• Expanded Disability Status Scale (EDSS) score of 0 - 5.5 at screening.

• A diagnosis of RMS in accordance with the revised 2017 McDonald Criteria.

• Ability to complete the 9-Hole Peg Test (9-HPT) for each hand in < 240 seconds.

• Ability to perform the Timed 25-Foot Walk Test (T25FWT) in <150 seconds.

• 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.

• Hypoproteinemia.

• Participants with severe 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.

OLE 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.