Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sanofi
Study ID
NCT04410978
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 — 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 population pharmacokinetics (PK) of SAR442168 and relevant metabolites and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

Key Dates

Start date
Jun 30, 2020
Status verified
Jun 2025
Primary completion
Jul 15, 2024
Completion
Jul 15, 2024

Study Design

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

Arms

  • Experimental: SAR442168
    60 mg oral SAR442168 + placebo to match the teriflunomide tablet once daily
  • Active Comparator: Teriflunomide
    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 (23)

FacilityCityStateZIPSite coordinators
University of Alabama MS Center-Site Number:8400013BirminghamAlabama35233-
University of San Francisco, Sandler Neurosciences Center-Site Number:8400137San FranciscoCalifornia94158-
University of Colorado-Site Number:8400012AuroraColorado80045-
Georgetown University Medical Center-Site Number:8400119Washington D.C.District of Columbia20007-
Beth Israel Deaconess Medical Center-Site Number:8400064Fort MyersFlorida33919-
Axiom Clinical Research of Florida-Site Number:8400001TampaFlorida33609-4052-
University of South Florida-Site Number:8400006TampaFlorida33612-
Meridian Clinical Research-Site Number:8400003SavannahGeorgia31406-
Consultants In Neurology-Site Number:8400011NorthbrookIllinois60062-
Tufts Medical Center-Site Number:8400072BostonMassachusetts02111-
Michigan Institute For Neurological Disorders-Site Number:8400058Farmington HillsMichigan48334-
The Memorial Hospital-Site Number:8400033OwossoMichigan48867-
Sharlin Health & Neurology-Site Number:8400093OzarkMissouri65721-
Missouri Baptist Medical Center-Site Number:8400019St LouisMissouri63131-
Meridian Clinical Research, LLC-Site Number:8400005RaleighNorth Carolina27607-
Wake Forest University Baptist Medical Center-Site Number:8400116Winston-SalemNorth Carolina27157-
Optimed Research, LTD-Site Number:8400147ColumbusOhio43235-
The Ohio State University Wexner Medical Center-Site Number:8400150ColumbusOhio43221-
Columbus Neuroscience-Site Number:8400010WestervilleOhio40382-
Oklahoma Medical Research Foundation-Site Number:8400018Oklahoma CityOklahoma73104-
Providence Multiple Sclerosis Center-Site Number:8400020PortlandOregon97225-
University of Texas Southwestern Medical Center-Site Number:8400077DallasTexas75390-
Multiple Sclerosis Center, Swedish Neuroscience Institute-Site Number:8400121SeattleWashington98122-

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Find similar trials in Birmingham, AL

By research site
University of Alabama MS Center· Birmingham, ALUniversity of San Francisco, Sandler Neurosciences Center· San Francisco, CAUniversity of Colorado· Aurora, COGeorgetown University Medical Center· Washington D.C., DCBeth Israel Deaconess Medical Center· Fort Myers, FLAxiom Clinical Research of Florida· Tampa, FL

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