Long Term Safety and Efficacy Study of Tolebrutinib (SAR442168) in Participants With Relapsing Multiple Sclerosis

Part of paid clinical trials in Cullman, Alabama.

Sponsor
Sanofi
Study ID
NCT03996291
Phase
PHASE2
Status
Completed

Conditions

  • Relapsing Multiple Sclerosis

Eligibility Criteria

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

Interventions

  • Tolebrutinib — DRUG
    Pharmaceutical form: Film coated tablet Route of administration: Oral

Study Details

Primary Objective: To determine the long-term safety and tolerability of SAR442168 in RMS participants Secondary Objective: To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging methods

Key Dates

Start date
Sep 23, 2019
Status verified
Oct 2025
Primary completion
Nov 26, 2024
Completion
Nov 26, 2024

Study Design

Enrollment
125 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SAR442168
    SAR442168 : Experimental - Part A: Double-blind period of continued treatment with the respective SAR442168 dose was administered in the DRI15928 study until selection of Phase 3 dose. Part B: Open-label period of a single-group treatment with SAR442168 selected Phase 3 dose of 60 mg. All participants were switched to this 60 mg dose.

Primary Outcome Measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) [ Time Frame: From first dose of study drug (Day 1) up to maximum exposure, 39 weeks in Part A and 222 weeks in Part B ]

Locations (8)

FacilityCityStateZIPSite coordinators
North Central Neurology Associates, PC Site Number : 8400005CullmanAlabama35058-
Neurology Associates, PA Site Number : 8400002MaitlandFlorida32761-
University of South Florida Site Number : 8400009TampaFlorida33612-
Velocity Clinical Research Site Number : 8400007SavannahGeorgia31406-
Consultants In Neurology Site Number : 8400001NorthbrookIllinois60062-
UC Health, LLC Site Number : 8400008DaytonOhio45417-
MDH Research LLC Site Number : 8400006WestervilleOhio43081-
Neurology PC Site Number : 8400003KnoxvilleTennessee37922-

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By research site
North Central Neurology Associates, PC· Cullman, ALNeurology Associates, PA· Maitland, FLUniversity of South Florida· Tampa, FLVelocity Clinical Research· Savannah, GAConsultants In Neurology· Northbrook, ILUC Health, LLC· Dayton, OH

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