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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
751
Participants will receive fenebrutinib.
Participants will receive teriflunomide.
Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
Annualized Relapse Rate (ARR)
Time frame: Minimum of 96 weeks
Time to Onset of Composite 12-week Confirmed Disability Progression (cCDP12)
Time frame: Minimum of 96 weeks
Time to Onset of Composite 24-week Confirmed Disability Progression (cCDP24)
Time frame: Minimum of 96 weeks
Time to Onset of 12-week Confirmed Disability Progression (CDP12)
Time frame: Minimum of 96 weeks
Time to Onset of 24-week Confirmed Disability Progression (CDP24)
Time frame: Minimum of 96 weeks
Total Number of T1 Gadolinium-enhancing (Gd+) Lesions, New and/or Enlarging T2-weighted Lesions, as Detected by Magnetic Resonance Imaging (MRI)
Time frame: Baseline, Weeks 12, 24, 48 and 96
Percentage Change in Total Brain Volume From Week 24, as Assessed by MRI
Time frame: From Week 24 to Week 96
Change in Participant-reported Physical Impacts of Multiple Sclerosis (MS), Measured by the Multiple Sclerosis, Impact Scale (29-Item), Version 2 (MSIS-29 v2) Physical Scale
The MSIS-29 v2 is a 29-item participant-reported measure of the physical and psychological impacts of MS. Participants are asked to rate how much their functioning and well-being have been impacted over the past 14 days on a 4-point scale, ranging from "Not at all" (1) to "Extremely" (4). The physical score is the sum of items 1-20, which is then transformed to a 0-100 scale. The psychological score is the sum of items 21-29, transformed to a 0-100 scale. Higher scores indicate a greater impact of MS.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
North Central Neurology Associates
Cullman, Alabama, United States
Xenoscience
Phoenix, Arizona, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance, California, United States
KI Health Partners, LLC
Stamford, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
University of South Florida
Tampa, Florida, United States
American Health Network Institute, LLC
Avon, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Neuro Institute of New England P.C.
Foxborough, Massachusetts, United States
University of Cincinnati
Cincinnati, Ohio, United States
...and 98 more locations
Time frame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84 and 96
Time to Onset of 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) Score
The SDMT is used for detecting the presence of cognitive impairment and changes in cognitive functioning over time and in response to treatment. The SDMT is a brief, easy-to-administer test, involving a simple substitution task. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected only orally, and the administration time is approximately 5 minutes. The number of correct responses in 90 seconds will be considered the SDMT score. A decrease by 4 points on the SDMT score from baseline represents a clinically meaningful change in cognitive processing. The SDMT score ranges from 0 to 110. The higher the results, the better processing speed/working memory.
Time frame: Minimum of 96 weeks
Change From Baseline to Week 48 in the Concentration of Blood Neurofilament Light Chain (NfL)
Time frame: Up to 48 weeks
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to 4.5 years
Plasma Concentrations of Fenebrutinib at Specified Timepoints
Time frame: Up to 4.5 years
Time to Onset of Composite 12-week Confirmed Progression Independent of Relapse Activity (cPIRA12)
Time frame: Minimum of 96 weeks