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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 55 Years
Gender	All

More Inclusion & Exclusion 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 primary progressive MS (PPMS) or non-active secondary progressive MS (SPMS).

- Any known or suspected active infection at screening, including but not limited to a positive screening test 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, that could interfere with the diagnosis of MS or assessments of efficacy or safety during the study and 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.

- Presence of cirrhosis (Child-Pugh Class A, B, or C) 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 human immunodeficiency virus (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 accelerated teriflunomide elimination procedure (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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04586010
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hoffmann-La Roche
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trials
Principal Investigator Affiliation	Hoffmann-La Roche
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Algeria, Argentina, China, Dominican Republic, Finland, Georgia, Germany, Hong Kong, Hungary, Italy, Kenya, Mexico, Morocco, Netherlands, North Macedonia, Peru, Poland, Portugal, Russian Federation, Serbia, Spain, Switzerland, Taiwan, Tunisia, Ukraine, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Fenebrutinib

Participants will receive oral fenebrutinib with teriflunomide-matching placebo.

Active Comparator: Teriflunomide

Participants will receive oral teriflunomide with fenebrutinib-matching placebo in a blinded fashion.

Interventions

Drug: - Fenebrutinib

Participants will receive fenebrutinib.

Drug: - Teriflunomide

Participants will receive teriflunomide.

Drug: - Placebo

Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama Birmingham, Birmingham, Alabama

Status

Active, not recruiting

Address

University of Alabama Birmingham

Birmingham, Alabama, 35233

Site Contact

Clinical Trial Finder

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Study Purpose

Recruitment Criteria

Inclusion Criteria:

Exclusion Criteria:

Inclusion Criteria:

Trial Details

Arms

Interventions

Contact a Trial Team

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