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
NCT05156281
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 13, 2021
Status verified
May 2026
Primary completion
Jul 23, 2026
Completion
Oct 30, 2030

Study Design

Enrollment
1,007 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 (50)

FacilityCityStateZIPSite coordinators
Ctr for Neurology and SpinePhoenixArizona85018-
Vladimir Royter MD APMCHanfordCalifornia93230-
VA Greater LA Healthcare SystemLos AngelesCalifornia90073-
Regina Berkovich MD PhD IncWest HollywoodCalifornia90048-
CU Anschutz Med CampusAuroraColorado80045-
Colorado Neurological Research PCDenverColorado80210-
New England Institute for Clinical ResearchStamfordConnecticut06905-
Georgetown University HospitalWashington D.C.District of Columbia20007-
Georgetown University Hospital ResearchWashington D.C.District of Columbia20007-
Nova Clinical Research LLCBradentonFlorida34209-
University of FloridaGainesvilleFlorida32610-
Memorial Healthcare SystemHollywoodFlorida33021-
Neurology Associates PAMaitlandFlorida32751-
Gables NeurologyMiamiFlorida33133-
UM Department Of NeurologyMiamiFlorida33136-
Aqualane Clinical ResearchNaplesFlorida34105-
Advent Health OrlandoOrlandoFlorida32803-
Humanity Clinical ResearchPembroke PinesFlorida33024-
Emerald Coast NeurologyPensacolaFlorida32514-
Brain and Spine InstitutePort OrangeFlorida32127-
Vero Beach NeurologyVero BeachFlorida32960-
Conquest ResearchWinter ParkFlorida32789-
Methodist Neuroscience InstituteMerrillvilleIndiana46410-
University of Kansas HospitalKansas CityKansas66160-
Baptist Physicians LexingtonNicholasvilleKentucky40356-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Clinre Comprehensive NeurologyFrederickMaryland21702-
Tufts Medical CenterBostonMassachusetts02111-
Kansas City VA Medical CenterKansas CityMissouri64128-
South Shore Neurologic AssociatesPatchogueNew York11772-
University Of NC At Chapel HillChapel HillNorth Carolina27599 9500-
Piedmont HealthCareCharlotteNorth Carolina28210-
The Boster Ctr for MSColumbusOhio43235-
Neurology Diagnostics IncDaytonOhio45408-
Penn State Hershey Medical CenterHersheyPennsylvania17033-
Premier NeurologyGreenvilleSouth Carolina29605-
Metrolina Neurological Associates PAOld Point StationSouth Carolina29707-
Sibyl Wray MD Neurology PCKnoxvilleTennessee37922-
Neurology Consultants Of Dallas PADallasTexas75231-
Med Research IncEl PasoTexas79935-
Lone Star NeurologyFriscoTexas75035-
Lonestar Neurology of San AntonioSan AntonioTexas78258-
UT Health MARC Medical Arts and Research CenterSan AntonioTexas78229-
Texas Institute for Neurological DisordersShermanTexas75092-
Baylor Scott and WhiteTempleTexas76508-
University of Washington MS ClinicSeattleWashington98133-
Virginia Mason Medical CentreSeattleWashington98101-
Elligo Health ResearchCrab OrchardWest Virginia25827-
Ascension St Francis CenterMilwaukeeWisconsin53215-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Phoenix, AZ

By research site
Ctr for Neurology and Spine· Phoenix, AZVladimir Royter MD APMC· Hanford, CAVA Greater LA Healthcare System· Los Angeles, CARegina Berkovich MD PhD Inc· West Hollywood, CACU Anschutz Med Campus· Aurora, COColorado Neurological Research PC· Denver, CO

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