©2022 Stanford Medicine
Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)
Recruiting
Trial ID: NCT04586023
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.
Official Title
A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis
Stanford Investigator(s)
Lucas Kipp
Clinical Associate Professor, Neurology & Neurological Sciences
Eligibility
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 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, 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.
Intervention(s):
drug: fenebrutinib
drug: teriflunomide
drug: placebo
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305