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New MS drug shows promise in Long-Term safety trial

NCT ID NCT03996291

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the long-term safety of the drug SAR442168 in 125 people with relapsing multiple sclerosis who had already completed a previous study. Researchers monitored side effects and checked brain scans for disease activity over about 4.5 years. The goal was to see if the drug remains safe and helps control the disease over time.

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

125 people

The number who actually took part.

Started

Sep 2019

Finished

Nov 2024

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: * 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.

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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

  • Consultants In Neurology Site Number : 8400001

    Northbrook, Illinois, 60062, United States

  • Investigational Site Number : 1240001

    Greenfield Park, Quebec, J4V 2J2, Canada

  • Investigational Site Number : 1240003

    Vancouver, British Columbia, 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 : 2500004

    Nancy, 54035, France

  • Investigational Site Number : 5280001

    Amsterdam, 1081 HV, Netherlands

  • Investigational Site Number : 6430001

    Saint Petersburg, 197110, Russia

  • Investigational Site Number : 6430003

    Moscow, 125367, Russia

  • Investigational Site Number : 6430005

    Saint Petersburg, 194044, Russia

  • Investigational Site Number : 6430006

    Kazan', 420032, Russia

  • Investigational Site Number : 6430007

    Tyumen, 625000, Russia

  • Investigational Site Number : 7240001

    Madrid, 28007, Spain

  • Investigational Site Number : 7240002

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240003

    Seville, Andalusia, 41009, Spain

  • Investigational Site Number : 7240004

    Murcia, 30120, Spain

  • Investigational Site Number : 7240005

    Salt, Girona [Gerona], 17190, Spain

  • Investigational Site Number : 8040001

    Lviv, 79010, Ukraine

  • Investigational Site Number : 8040002

    Chernivtsi, 58000, Ukraine

  • Investigational Site Number : 8040003

    Vinnytsia, 21005, Ukraine

  • Investigational Site Number : 8040005

    Dnipro, 49038, Ukraine

  • Investigational Site Number : 8040006

    Lviv, 79013, Ukraine

  • Investigational Site Number : 8040007

    Zhytomyr, 10002, Ukraine

  • Investigational Site Number : 8040009

    Odesa, 65025, Ukraine

  • MDH Research LLC Site Number : 8400006

    Westerville, Ohio, 43081, United States

  • Neurology Associates, PA Site Number : 8400002

    Maitland, Florida, 32761, United States

  • Neurology PC Site Number : 8400003

    Knoxville, Tennessee, 37922, United States

  • North Central Neurology Associates, PC Site Number : 8400005

    Cullman, Alabama, 35058, United States

  • UC Health, LLC Site Number : 8400008

    Dayton, Ohio, 45417, United States

  • University of South Florida Site Number : 8400009

    Tampa, Florida, 33612, United States

  • Velocity Clinical Research Site Number : 8400007

    Savannah, Georgia, 31406, United States

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