Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT05147220
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

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

Interventions

  • Remibrutinib — DRUG
    tablet taken orally
  • Teriflunomide — DRUG
    capsule taken orally

Study Details

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

Key Dates

Start date
Dec 16, 2021
Status verified
May 2026
Primary completion
Jul 23, 2026
Completion
Oct 30, 2030

Study Design

Enrollment
1,000 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Remibrutinib - Core
    Remibrutinib tablet and matching placebo of teriflunomide capsule
  • Active Comparator: Teriflunomide - Core
    Teriflunomide capsule and matching placebo remibrutinib tablet
  • Experimental: Remibrutinib - Extension
    Participants on remibrutinib in Core will continue on remibrutinib tablet
  • Experimental: Remibrutinib - Extension (on teriflunomide in Core)
    Participants on teriflunomide in Core will switch to remibrutinib tablet

Primary Outcome Measure

Annualized relapse rate (ARR) of confirmed relapses [Core Part] [ Time Frame: From Baseline, up to 30 months ]

Locations (52)

FacilityCityStateZIPSite coordinators
AZ Integrated Neuro and SpinePhoenixArizona85037-
Center for NeurosciencesTucsonArizona85718-
The Belinga ClinicFort SmithArkansas72916-
The Research and Education Inst of Alta Bates Summit Med GrpBerkeleyCalifornia94705-
The Neuron ClinicChula VistaCalifornia91910-
Glendale Adventist Medical CenterGlendaleCalifornia91206-
Hoag Health SystemNewport BeachCalifornia92663-
SC3 Research PasadenaPasadenaCalifornia91105-
Neuro CenterPomonaCalifornia91767-
Alpine Clinical Research CenterBoulderColorado80301-
Christiana Care Health ServicesNewarkDelaware19713-
Washington Hospital CenterWashington D.C.District of Columbia20010-
Neurology of Central FL Res CtrAltamonte SpringsFlorida32714-
Arrow Clinical TrialsDaytona BeachFlorida32117-
Homestead Assoc In Research IncHomesteadFlorida33033-
Reliant Medical ResearchMiamiFlorida33165-
Comprehensive Neurology ClinicOrlandoFlorida32825-
Neurological Services of Orlando PAOrlandoFlorida32806-
Orlando Health Clinical TrialsOrlandoFlorida32806-
Neurology Associates of Ormond BeachOrmond BeachFlorida32174-
Neurostudies IncPort CharlotteFlorida33952-
Accel Research Sites St Pete-LargoSeminoleFlorida33777-
University Of South FloridaTampaFlorida33612-
Conquest ResearchWinter ParkFlorida32789-
Rush University Medical CenterChicagoIllinois60612-
IU Health IncFort WayneIndiana46815-
College Park Family Care CenterOverland ParkKansas66210-
Norton Neurology MS ServicesLouisvilleKentucky40207-
American Oncology Partners PA Center for Cancer and Blood DisordersBethesdaMaryland20817-
Neurology Center of New England PCFoxboroughMassachusetts02035-
Wayne State University Multiple Sclerosis ClinicDetroitMichigan48201-
The MS Center for Innovation in CareSt LouisMissouri63131-
SCL HealthBillingsMontana59101-
Jersey Shore University Medical CtrNeptune CityNew Jersey07753-
Neurological Associates of Long Island PCLake SuccessNew York11042-
NYU Langone Med Center CV ResearchNew YorkNew York10016-
The Neurological Institute PACharlotteNorth Carolina28204-
Velocity Clinical ResearchRaleighNorth Carolina27607-
Columbus NeuroscienceWestervilleOhio43082-
Multiple Sclerosis Center of Excellence of OMRFOklahoma CityOklahoma73104-
Providence St Vincent Med CenterPortlandOregon97225-
University Of Pittsburgh Medical Ctr Magee-Womens HospitalPittsburghPennsylvania15213-
Reading HospitalReadingPennsylvania19611-
Palmetto Clinical ResearchSummervilleSouth Carolina29485-
Texas NeurologyDallasTexas75206-
John Peter Smith HospitalFort WorthTexas76104-
Neuro Eye Clinical Trials IncHoustonTexas77074-
DHR Health InstituteMcAllenTexas78504-
Saturn Research Solutions LLCPlanoTexas75024-
MS Center of Greater Washington, P.C.ViennaVirginia22182-
University of Wisconsin MadisonMadisonWisconsin53792-
Neuroscience GroupNeenahWisconsin54956-

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