Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

Part of paid clinical trials in Cullman, Alabama.

Sponsor
Sanofi
Study ID
NCT04410991
Phase
PHASE3
Status
Completed

Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

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

Interventions

  • Tolebrutinib — DRUG
    Pharmaceutical form: Tablet Route of administration: Oral
  • Teriflunomide HMR1726 — DRUG
    Pharmaceutical form: Tablet Route of administration: Oral
  • Placebo to match Tolebrutinib — DRUG
    Pharmaceutical form: Tablet Route of administration: Oral
  • Placebo to match Teriflunomide — DRUG
    Pharmaceutical form: Tablet Route of administration: Oral

Study Details

Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168

Key Dates

Start date
Jun 11, 2020
Status verified
Jun 2025
Primary completion
Jul 16, 2024
Completion
Jul 16, 2024

Study Design

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

Arms

  • Experimental: SAR442168
    Dose 1 of oral SAR442168 daily + placebo to match the teriflunomide tablet once daily
  • Active Comparator: Teriflunomide
    Oral 14 mg oral teriflunomide + placebo to match the SAR442168 tablet once daily

Primary Outcome Measure

Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses [ Time Frame: Baseline (Day 1) to approximately 48 months ]

Locations (43)

FacilityCityStateZIPSite coordinators
North Central Neurology Associates, PC-Site Number:8400009CullmanAlabama35058-
Center for Neurology and Spine-Site Number:8400089PhoenixArizona84018-
Arcadia Neurology Center-Site Number:8400070ArcadiaCalifornia91006-
Multiple Sclerosis Center of California-Site Number:8400135Newport BeachCalifornia92663-
Harbor UCLA-Site Number:8400088TorranceCalifornia90502-
Mountain Neurological Research Center, Inc.-Site Number:8400128BasaltColorado81621-
Advanced Neurosciences Research-Site Number:8400025Fort CollinsColorado80528-
South Florida Neurology Associates-Site Number:8400029Boca RatonFlorida33487-
University of Florida Health-Site Number:8400159GainesvilleFlorida32608-
Neurology Associates, PA-Site Number:8400004MaitlandFlorida32761-
University of Miami-Site Number:8400063MiamiFlorida33136-
Infinity Clinical Research-Site Number:8400008SunriseFlorida33351-
University of South Florida-Site Number:8400006TampaFlorida33612-
Meridian Clinical Research-Site Number:8400003SavannahGeorgia31406-
Consultants In Neurology-Site Number:8400011NorthbrookIllinois60062-
Prairie Education and Research Cooperative-Site Number:8400071SpringfieldIllinois62701-
Fort Wayne Neurological Center-Site Number:8400039Fort WayneIndiana46804-
CHI Saint Joseph Medical Group Neurology-Site Number:8400110LexingtonKentucky40509-
University of Kentucky-Site Number:8400106LexingtonKentucky40536-
Norton Neurology MS Services-Site Number:8400127LouisvilleKentucky40207-
The NeuroMedical Center-Site Number:8400057Baton RougeLouisiana70810-
International Neurorehabilitation Institute-Site Number:8400034Lutherville-TimoniumMaryland21093-
Wayne State University-Site Number:8400046DetroitMichigan48201-
Minneapolis Clinic of Neurology-Site Number:8400051MinneapolisMinnesota55422-
Saint Luke's Hospital-Site Number:8400153Kansas CityMissouri64111-
University Of Nebraska-Site Number:8400129OmahaNebraska68198-
West Omaha Family Physicians-Site Number:8400139OmahaNebraska68130-
Hackensack University Hospital-Site Number:8400047HackensackNew Jersey07601-
University of New Mexico-Site Number:8400032AlbuquerqueNew Mexico87131-
South Shore Neurologic Associates-Site Number:8400100PatchogueNew York11772-
Novant Health Multiple Sclerosis Care Center - South Park-Site Number:8400120CharlotteNorth Carolina28210-
Meridian Clinical Research, LLC-Site Number:8400005RaleighNorth Carolina27607-
Sanford Brain & Spine Center-Site Number:8400126FargoNorth Dakota58103-
Dayton Center for Neurological Disorders-Site Number:8400081CentervilleOhio45459-
Jefferson Neurology Associates-Site Number:8400016PhiladelphiaPennsylvania19107-
Premier Neurology-Site Number:8400069GreerSouth Carolina29650-
Advanced Neuroscience Center-Site Number:8400035FranklinTennessee37064-
Sibyl Wray, MD, Neurology, PC-Site Number:8400007KnoxvilleTennessee37922-
Mt Olympus Medical Research-Site Number:8400163KatyTexas77450-
Neurology Center of San Antonio-Site Number:8400036San AntonioTexas78258-
Texas Institute for Neuroogical Disorders-Sherman-Site Number:8400151ShermanTexas75092-
Neurological Associates-Site Number:8400097RichmondVirginia23229-
Wheaton Franciscan Healthcare-Site Number:8400022MilwaukeeWisconsin53215-

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By research site
North Central Neurology Associates, PC· Cullman, ALCenter for Neurology and Spine· Phoenix, AZArcadia Neurology Center· Arcadia, CAMultiple Sclerosis Center of California· Newport Beach, CAHarbor UCLA· Torrance, CAMountain Neurological Research Center, Inc.· Basalt, CO

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