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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT04586010
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Fenebrutinib — DRUG
    Participants will receive fenebrutinib.
  • Teriflunomide — DRUG
    Participants will receive teriflunomide.
  • Placebo — DRUG
    Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.

Study Details

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.

Key Dates

Start date
Mar 17, 2021
Status verified
May 2026
Primary completion
Jan 27, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
746 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fenebrutinib
    Participants will receive oral (PO) fenebrutinib, with teriflunomide-matching placebo.
  • Active Comparator: Teriflunomide
    Participants will receive PO teriflunomide, with fenebrutinib-matching placebo in a blinded fashion.

Primary Outcome Measure

Annualized Relapse Rate (ARR) [ Time Frame: Minimum of 96 weeks ]

Locations (32)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233-
Alabama Neurology AssociatesHomewoodAlabama35209-
Center for Neurology and Spine - Phoenix - Hunt - PPDSPhoenixArizona85032-
Profound Research, LLCCarlsbadCalifornia92011-
University of California IrvineIrvineCalifornia92697-
Quantum Clinical Research, IncPasadenaCalifornia91106-
University of Colorado DenverAuroraColorado80045-
Mountain View Clinical ResearchDenverColorado80209-
Advanced Neurology of Colorado, LLCFort CollinsColorado80528-
Neurology Associates, PA; Research DepartmentMaitlandFlorida32751-
NorthShore University HealthSystemHighland ParkIllinois60035-
Fort Wayne Neurological CenterFort WayneIndiana46805-
The NeuroMedical CenterBaton RougeLouisiana70810-
Ochsner LSU HealthShreveportLouisiana71103-
Johns Hopkins University School Of Medicine; Outpatient CenterBaltimoreMaryland21287-
University of Massachusetts Medical SchoolWorcesterMassachusetts01655-
Henry Ford Health SystemDetroitMichigan48202-
Washington University School of MedicineSt LouisMissouri63110-
Holy Name Hospital; Institute For Clinical ResearchTeaneckNew Jersey07666-
University of New Mexico; MS Specialty ClinicAlbuquerqueNew Mexico87131-
Miami Valley Hospital South; Dayton Physician's OfficeCentervilleOhio45459-
OhioHealthColumbusOhio43214-
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare CompanyColumbusOhio43235-
Oklahoma Medical Research Foundation; MS Center of ExcellenceOklahoma CityOklahoma73104-
St. Luke's University Health networkBethlehemPennsylvania18015-
Premier NeurologyGreenvilleSouth Carolina29605-
New Orleans Center for Clinical ResearchKnoxvilleTennessee37920-
North Texas Institute of Neurology and Headache NextStage Clinical Research ClinicPlanoTexas75024-
Texas Institute for Neurological DisordersShermanTexas75092-
Multiple Sclerosis Center of Greater WashingtonViennaVirginia22182-
Evergreen MS CenterKirklandWashington98034-
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological DisordersMilwaukeeWisconsin53215-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By research site
University of Alabama Birmingham· Birmingham, ALAlabama Neurology Associates· Homewood, ALCenter for Neurology and Spine - Phoenix - Hunt - PPDS· Phoenix, AZProfound Research, LLC· Carlsbad, CAUniversity of California Irvine· Irvine, CAQuantum Clinical Research, Inc· Pasadena, CA

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