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New pill shows promise in shrinking MS brain lesions

NCT ID NCT03889639

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2b trial tested an experimental oral drug called SAR442168 in 130 adults with relapsing multiple sclerosis. The goal was to find the best dose to reduce new active brain lesions seen on MRI scans. Participants took the drug or a placebo for 12 to 16 weeks, and researchers measured lesion counts and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR442168 (a Bruton's tyrosine kinase inhibitor, taken as a pill)
What this could lead to
If successful, this could lead to a new oral treatment option that reduces brain lesion activity in people with relapsing multiple sclerosis.
What could go wrong
This is a phase 2b dose-finding study with only 130 participants, so results may not confirm effectiveness or safety in larger, longer trials. The drug may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

130 people

The number who actually took part.

Started

Mar 2019

Finished

Jan 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent. * Participant was diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria. * Participant must had at least 1 documented relapse within the previous year, OR greater than or equal to (\>=) 2 documented relapses within the previous 2 years, OR \>=1 active Gadolinium (Gd) enhancing brain lesion on an MRI scan in the past 6 months and prior to screening. * A female participant must had used a double contraception method including a highly effective method of birth control from inclusion and up to 2 months after the last study dose, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for \>=12 months with serum follicle-stimulating hormone (FSH) level greater than (\>) 30 International Units per liters. * Male participants, whose partners were of childbearing potential (including breastfeeding women), must had accepted to use, during sexual intercourse, a double contraceptive method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from inclusion up to 3 months after the last dose. * Male participants whose partners were pregnant must had used, during sexual intercourse, a condom from inclusion up to 3 months after the last dose. * Male participants had agreed not to donate sperm from the inclusion up to 3 months after the last dose. * Participant had given written informed consent prior to undertaking any study-related procedure. Exclusion criteria: * The participant had been diagnosed with primary progressive multiple sclerosis according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis. * Requirement for concomitant treatment that could bias the primary evaluation. * Contraindication for MRI. * Contraindications to use MRI Gd contrast-enhancing preparations. * History of infection with the human immunodeficiency virus (HIV). * History of active or latent tuberculosis. * Any other active infections that would adversely affect participation or investigational medicinal product administration in this study, as judged by the Investigator. * Presence of any screening laboratory or electrocardiogram values outside normal limits that were considered in the Investigator's judgment to be clinically significant. * Presence of liver injury. * At screening, the participant was positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or was positive for hepatitis C antibody. * Bleeding disorder or known platelet dysfunction at any time prior to screening visit. * Participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit. * Participant was receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes. * Participant was receiving anticoagulant/antiplatelet therapies. * Participant had taken other investigational drugs within 3 months or 5 half lives, whichever was longer, before screening visit. * Participant had an Expanded Disability Status Scale score \>5.5 at first screening visit. * Participant had a relapse in the 30 days prior to randomization. * Participant was pregnant or a breastfeeding woman. * History or presence of significant other concomitant illness. * The participant had received medications/treatments for multiple sclerosis within a specified time frame. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

Contacts and locations

Locations

  • Investigational Site Number 1240001

    Greenfield Park, J4V 2J2, Canada

  • Investigational Site Number 1240002

    Gatineau, J8Y 1W2, Canada

  • Investigational Site Number 1240003

    Vancouver, V6T 2B5, Canada

  • Investigational Site Number 2030001

    Prague, 12808, Czechia

  • Investigational Site Number 2030002

    Praha 5 - Motol, 15006, Czechia

  • Investigational Site Number 2030003

    Jihlava, 58633, Czechia

  • Investigational Site Number 2030004

    Hradec Králové, 50005, Czechia

  • Investigational Site Number 2030005

    Ostrava - Poruba, 70852, Czechia

  • Investigational Site Number 2030006

    Pardubice, 53203, Czechia

  • Investigational Site Number 2030007

    Brno, 62500, Czechia

  • Investigational Site Number 2330001

    Tallinn, 11315, Estonia

  • Investigational Site Number 2500001

    Nantes, 44093, France

  • Investigational Site Number 2500002

    Strasbourg, 67098, France

  • Investigational Site Number 2500003

    Toulouse, 31059, France

  • Investigational Site Number 2500004

    Nancy, 54035, France

  • Investigational Site Number 5280001

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number 5280002

    Sittard-Geleen, 6162 BG, Netherlands

  • Investigational Site Number 6430001

    Saint Petersburg, 197110, Russia

  • Investigational Site Number 6430002

    Moscow, 127015, Russia

  • Investigational Site Number 6430003

    Moscow, 125367, Russia

  • Investigational Site Number 6430004

    Saint Petersburg, 197022, Russia

  • Investigational Site Number 6430005

    Saint Petersburg, 194044, Russia

  • Investigational Site Number 6430006

    Kazan', 420021, Russia

  • Investigational Site Number 6430007

    Tyumen, 625000, Russia

  • Investigational Site Number 7030001

    Bratislava, 82606, Slovakia

  • Investigational Site Number 7030002

    Martin, 03659, Slovakia

  • Investigational Site Number 7240001

    Madrid, 28007, Spain

  • Investigational Site Number 7240002

    Barcelona, 08035, Spain

  • Investigational Site Number 7240003

    Seville, 41071, Spain

  • Investigational Site Number 7240004

    Murcia, 30120, Spain

  • Investigational Site Number 7240005

    Salt, 17190, Spain

  • Investigational Site Number 7240006

    Barakaldo, 48903, Spain

  • Investigational Site Number 8040001

    Lviv, 79010, Ukraine

  • Investigational Site Number 8040002

    Chernivtsi, 58018, Ukraine

  • Investigational Site Number 8040003

    Vinnytsia, 21005, Ukraine

  • Investigational Site Number 8040005

    Dnipro, 49005, Ukraine

  • Investigational Site Number 8040006

    Lviv, 79013, Ukraine

  • Investigational Site Number 8040007

    Zhytomyr, 10002, Ukraine

  • Investigational Site Number 8040009

    Odesa, 65025, Ukraine

  • Investigational Site Number 8400001

    Northbrook, Illinois, 60062, United States

  • Investigational Site Number 8400002

    Maitland, Florida, 32761, United States

  • Investigational Site Number 8400003

    Knoxville, Tennessee, 37922, United States

  • Investigational Site Number 8400004

    Sunrise, Florida, 33351, United States

  • Investigational Site Number 8400005

    Cullman, Alabama, 35058, United States

  • Investigational Site Number 8400006

    Westerville, Ohio, 43081, United States

  • Investigational Site Number 8400007

    Savannah, Georgia, 31406, United States

  • Investigational Site Number 8400008

    Dayton, Ohio, 45417, United States

  • Investigational Site Number 8400009

    Tampa, Florida, 33612, United States

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