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

NCT ID: NCT03996291

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-23
• Study Completion Date: 2024-11-26

Brief Summary

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

Detailed Description

Approximately 62 months including the 8 weeks post-treatment visit

Conditions

Relapsing Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tolebrutinib

Intervention Type: DRUG

Pharmaceutical form: Film coated tablet Route of administration: Oral

Interventions

Tolebrutinib

Pharmaceutical form: Film coated tablet Route of administration: Oral

Intervention Type: DRUG

Other Intervention Names

SAR442168

Eligibility Criteria

Inclusion Criteria

• Participants had to have completed treatment in the DRI15928 study
• Female participants had to continue to use an acceptable effective contraception method of birth control from inclusion and until the last dose of study drug, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for ≥12 months with plasma follicle stimulating hormone (FSH) level >30 UI/L.
• The participant had to have given written informed consent prior to undertaking any study related procedure.

Exclusion Criteria

• The participant had a confirmed concomitant laboratory or ECG abnormality or medical condition deemed by the investigator incompatible with continuation of SAR442168 treatment.
• The participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) between the last DRI15928 visit and the first treatment visit in the LTS16004 study.
• The participant had received a non-study MS disease modifying treatment between the last IMP treatment in Study DRI15928 and inclusion in Study LTS16004, which by judgement of the Investigator may add unjustified risk to switching back and continuing treatment with SAR442168. Washout periods after treatment with non-study DMTs had to be respected except for interferons or glatiramer acetate treatment.
• The participant was receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes.
• The participant was receiving anticoagulant/antiplatelet therapies, including:

• Acetylsalicylic acid (aspirin)
• Antiplatelet drugs (eg, clopidogrel)
• Warfarin (vitamin K antagonist)
• Heparin, including low molecular weight heparin (antithrombin agents)
• Dabigatran (direct thrombin inhibitor)
• Apixaban, edoxaban, rivaroxaban (direct factor Xa inhibitors)

Note: All above drugs needed to be stopped at least 5 half-lives before study drug administration except for aspirin, which needed to be stopped at least 8 days beforehand.

• Prior/concurrent clinical study experience. The participant was taking part in another interventional clinical trial of another drug substance.
• Uncooperative behavior or any condition that could make the participant potentially non-adherent with the study procedures
• The participant was pregnant or was a breastfeeding woman.

The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

North Central Neurology Associates, PC Site Number : 8400005

Cullman, Alabama, United States

Neurology Associates, PA Site Number : 8400002

Maitland, Florida, United States

University of South Florida Site Number : 8400009

Tampa, Florida, United States

Velocity Clinical Research Site Number : 8400007

Savannah, Georgia, United States

Consultants In Neurology Site Number : 8400001

Northbrook, Illinois, United States

UC Health, LLC Site Number : 8400008

Dayton, Ohio, United States

MDH Research LLC Site Number : 8400006

Westerville, Ohio, United States

Neurology PC Site Number : 8400003

Knoxville, Tennessee, United States

Investigational Site Number : 1240003

Vancouver, British Columbia, Canada

Investigational Site Number : 1240001

Greenfield Park, Quebec, Canada

Investigational Site Number : 2030007

Brno, , Czechia

Investigational Site Number : 2030004

Hradec Králové, , Czechia

Investigational Site Number : 2030003

Jihlava, , Czechia

Investigational Site Number : 2030005

Ostrava - Poruba, , Czechia

Investigational Site Number : 2030006

Pardubice, , Czechia

Investigational Site Number : 2030001

Prague, , Czechia

Investigational Site Number : 2030002

Praha 5 - Motol, , Czechia

Investigational Site Number : 2330001

Tallinn, , Estonia

Investigational Site Number : 2500004

Nancy, , France

Investigational Site Number : 5280001

Amsterdam, , Netherlands

Investigational Site Number : 6430006

Kazan', , Russia

Investigational Site Number : 6430003

Moscow, , Russia

Investigational Site Number : 6430005

Saint Petersburg, , Russia

Investigational Site Number : 6430001

Saint Petersburg, , Russia

Investigational Site Number : 6430007

Tyumen, , Russia

Investigational Site Number : 7240003

Seville, Andalusia, Spain

Investigational Site Number : 7240002

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240005

Salt, Girona [Gerona], Spain

Investigational Site Number : 7240001

Madrid, , Spain

Investigational Site Number : 7240004

Murcia, , Spain

Investigational Site Number : 8040002

Chernivtsi, , Ukraine

Investigational Site Number : 8040005

Dnipro, , Ukraine

Investigational Site Number : 8040001

Lviv, , Ukraine

Investigational Site Number : 8040006

Lviv, , Ukraine

Investigational Site Number : 8040009

Odesa, , Ukraine

Investigational Site Number : 8040003

Vinnytsia, , Ukraine

Investigational Site Number : 8040007

Zhytomyr, , Ukraine

Countries

United States; Canada; Czechia; Estonia; France; Netherlands; Russia; Spain; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://sanofi.trialsummaries.com/Study/StudyDetails?id=25300&tenant=MT_SNY_9011

LTS16004 Plain Language Results Summary

Other Identifiers

U1111-1223-4256

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-004731-76

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

LTS16004

Identifier Type: -

Identifier Source: org_study_id