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
746
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), as Measured by the Multiple Sclerosis Impact Scale (29-item), Version 2 (MSIS-29) Physical Scale
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
Time frame: Minimum of 96 weeks
Percent Change From Baseline to Week 48 in the Concentration of Blood Neurofilament Light Chain (NfL)
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University of Alabama Birmingham
Birmingham, Alabama, United States
Alabama Neurology Associates
Homewood, Alabama, United States
Center for Neurology and Spine - Phoenix - Hunt - PPDS
Phoenix, Arizona, United States
Profound Research, LLC
Carlsbad, California, United States
University of California Irvine
Irvine, California, United States
Quantum Clinical Research, Inc
Pasadena, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Mountain View Clinical Research
Denver, Colorado, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Neurology Associates, PA; Research Department
Maitland, Florida, United States
...and 148 more locations
Time frame: Baseline, Week 48
Time to Onset of Composite 12-week Confirmed Progression Independent of Relapse Activity (cPIRA12)
Time frame: Minimum of 96 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