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

Part of paid clinical trials in Cullman, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT04586023
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 24, 2021
Status verified
Mar 2026
Primary completion
Sep 5, 2025
Completion
Jul 9, 2027

Study Design

Enrollment
751 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 (13)

FacilityCityStateZIPSite coordinators
North Central Neurology AssociatesCullmanAlabama35058-
XenosciencePhoenixArizona85004-
Los Angeles Biomedical Research Institute at Harbor-UCLATorranceCalifornia90502-
KI Health Partners, LLCStamfordConnecticut06905-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
University of South FloridaTampaFlorida33612-
American Health Network Institute, LLCAvonIndiana46123-
University of Kansas Medical CenterKansas CityKansas66160-
Neuro Institute of New England P.C.FoxboroughMassachusetts02035-
University of CincinnatiCincinnatiOhio45219-
Hope NeurologyKnoxvilleTennessee37922-
Integrated Neurology Services PLLCFalls ChurchVirginia22043-
Medical College of Wisconsin, Inc.MilwaukeeWisconsin53226-3596-

Related coverage on Hipa.ai

Find similar trials in Cullman, AL

By research site
North Central Neurology Associates· Cullman, ALXenoscience· Phoenix, AZLos Angeles Biomedical Research Institute at Harbor-UCLA· Torrance, CAKI Health Partners, LLC· Stamford, CTGeorgetown University Medical Center· Washington D.C., DCUniversity of South Florida· Tampa, FL

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