Fenebrutinib: Participants will receive fenebrutinib.
Teriflunomide: Participants will receive teriflunomide.
Placebo: Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Study 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 in a 1:1 ratio to receive either fenebrutinib or teriflunomide. At the end of the double-blind treatment (DBT) phase (after disclosure of the DBT results), the Sponsor will determine whether or not to initiate the open-label extension (OLE) phase of the study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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
OLE Inclusion Criteria:
* Completed the 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
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 (HBV) and hepatitis C (HCV), 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 (GI) disease
* Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption
* Hypoproteinemia
* Acute liver disease
* Chronic liver disease unless considered stable for \> 6 months
* 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 Exclusion Criteria:
* Chronic liver disease unless considered stable for \> 6 months
* Acute liver disease
Primary outcome measure(s)
Annualized Relapse Rate (ARR) — Minimum of 96 weeks
Trial sites (106)
Facility
City
Region
Status
North Central Neurology Associates
Cullman
Alabama
Xenoscience
Phoenix
Arizona
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance
California
Georgetown University Medical Center
Washington D.C.
District of Columbia
University of South Florida
Tampa
Florida
American Health Network Institute, LLC
Avon
Indiana
University of Kansas Medical Center
Kansas City
Kansas
Neuro Institute of New England P.C.
Foxborough
Massachusetts
University of Cincinnati
Cincinnati
Ohio
Hope Neurology
Knoxville
Tennessee
Integrated Neurology Services PLLC
Falls Church
Virginia
Medical College of Wisconsin, Inc.
Milwaukee
Wisconsin
Kepler Universitätskliniken GmbH - Med Campus III
Linz
Austria
L2 Ip Instituto de Pesquisas Clinicas Ltda ME
Brasília
Federal District
Freire Pesquisa Clinica
Belo Horizonte
Minas Gerais
Instituto de Neurologia de Curitiba
Curitiba
Paraná
IMV Pesquisa Neurológica
Porto Alegre
Rio Grande do Sul
Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre
Rio Grande do Sul
Hospital Sao Lucas - PUCRS
Porto Alegre
Rio Grande do Sul
Clinica Neurologica
Joinville
Santa Catarina
Praxis Pesquisa Médica
Santo André
São Paulo
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo
São Paulo
Centro de Pesquisas Clinicas
São Paulo
São Paulo
Hospital Santa Marcelina
São Paulo
São Paulo
Jordy Sinapse Medicina LTDA ME
São Paulo
Brazil
UMHAT Dr. Georgi Stranski
Pleven
Bulgaria
MHATNP Sveti Naum EAD
Sofia
Bulgaria
University of Alberta Hospital
Edmonton
Alberta
The Ottawa Hospital - General Campus
Ottawa
Ontario
CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital
Chicoutimi
Quebec
MUCH - Montreal Neurological Institute & Hospital
Montreal
Quebec
CHU de Québec
Québec
Quebec
Sydvestjysk Sygehus Esbjerg
Esbjerg
Denmark
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
Sønderborg
Denmark
Hopital Gabriel Montpied CHU de Clermont-Ferrand
Clermont-Ferrand
France
Hôpital Pasteur
Nice
France
Hôpital Charles Nicolle
Rouen
France
CHU toulouse - Hôpital Purpan
Toulouse
France
Hospital Eginition
Athens
Greece
University General Hospital of Larisa
Larissa
Greece
+ 66 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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