Overview

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.