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COMPLETEDPHASE3

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

A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis

NCT04410978•Sanofi

View on ClinicalTrials.gov

Summary

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

Detailed Description

This was an event-driven (6-month confirmed disability worsening \[CDW\]) trial with a variable treatment duration (end-of-study \[EOS\] duration: up to approximately 48 months).

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent
•The participant must have been diagnosed with RMS according to the 2017 revision of the McDonald diagnostic criteria
•The participant has an expanded disability status scale (EDSS) score ≤5.5 at the first Screening Visit
•The participant must have at least 1 of the following prior to screening:
•* ≥1 documented relapse within the previous year OR
•* ≥2 documented relapses within the previous 2 years, OR
•* ≥1 documented Gd enhancing lesion on an MRI scan within the previous year
•Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
•Male participants are eligible to participate if they agree to the following during the intervention period and until accelerated elimination procedure:
•* Refrain from donating sperm
+11 more criteria

Exclusion Criteria

•The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with nonrelapsing secondary progressive multiple sclerosis (SPMS)
•The participant has a history of infection or may be at risk for infection including but not limited to: HIV, transplantation, live attenuated vaccines, progressive multifocal leukoencephalopathy, tuberculosis, any persistent chronic or active recurring infection
•Clinically significant laboratory abnormalities (including evidence of liver injury) or electrocardiogram abnormalities at Screening.
•The participant has conditions or situations that would adversely affect participation in this study, including but not limited to:
•* A short life expectancy due to pre-existing health condition(s) as determined by their treating neurologist
•* Medical condition(s) or concomitant disease(s) making them nonevaluable for the primary efficacy endpoint or that would adversely affect participation in this study, as judged by the Investigator
•* A requirement for concomitant treatment that could bias the primary evaluation
•The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study
•At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody
•The participant has any of the following:
+8 more criteria

Locations (179)

University of Alabama MS Center-Site Number:8400013

Birmingham, Alabama, United States

University of San Francisco, Sandler Neurosciences Center-Site Number:8400137

San Francisco, California, United States

University of Colorado-Site Number:8400012

Aurora, Colorado, United States

Georgetown University Medical Center-Site Number:8400119

Washington D.C., District of Columbia, United States

Beth Israel Deaconess Medical Center-Site Number:8400064

Fort Myers, Florida, United States

Axiom Clinical Research of Florida-Site Number:8400001

Tampa, Florida, United States

University of South Florida-Site Number:8400006

Tampa, Florida, United States

Meridian Clinical Research-Site Number:8400003

Savannah, Georgia, United States

Consultants In Neurology-Site Number:8400011

Northbrook, Illinois, United States

Tufts Medical Center-Site Number:8400072

Boston, Massachusetts, United States

Key Dates

Start Date

June 30, 2020

Primary Completion Date

July 15, 2024

Completion Date

July 15, 2024

Last Updated

July 2, 2025

Enrollment

974

ACTUAL participants

Conditions

Relapsing Multiple Sclerosis

Interventions

Tolebrutinib

DRUG

Teriflunomide

DRUG

Placebo to match Tolebrutinib

DRUG

Placebo to match Teriflunomide

DRUG

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

NCT07426991

Multiple SclerosisRemitting-Relapsing Multiple Sclerosis+4 more

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RECRUITING

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

NCT06433752

Relapsing Multiple SclerosisMultiple Sclerosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis

A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)

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