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New antibody shows promise in shrinking MS brain lesions

NCT ID NCT04879628

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 2 trial tests a drug called SAR441344, which blocks a protein (CD40L) involved in immune attacks. The goal is to see if it can reduce new active brain lesions in people with relapsing multiple sclerosis. About 129 adults aged 18-55 with relapsing MS are participating, and they receive either the drug or a placebo. The study is active but not recruiting, and results will help determine if larger trials are warranted.

What this could mean

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

Active substance
SAR441344 (a CD40L-blocking antibody)
What this could lead to
If successful, this could lead to a new treatment option that reduces brain lesion activity in people with relapsing multiple sclerosis.
What could go wrong
This is an early Phase 2 trial with only 129 participants, so results may not confirm effectiveness or safety. The drug may not work better than placebo or could have side effects.

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

129 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

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. * The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria. * The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening. * Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening. * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent. Exclusion criteria: * The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS. * The participant had conditions or situations that would adversely affect participation in this study. * The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study. * History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment. * Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule. * The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment. * The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit. * The participant had an EDSS score \>5.5 at the first screening visit. * The participant had a relapse in the 30 days prior to randomization. * Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission. * Abnormal laboratory test(s) at Screening. * Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention. * Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention. The above information is 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.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis

Contacts and locations

Locations

  • Center for Neurology and Spine- Site Number : 8400007

    Phoenix, Arizona, 85032, United States

  • Investigational Site Number : 1000001

    Sofia, 1407, Bulgaria

  • Investigational Site Number : 1000002

    Pleven, 5809, Bulgaria

  • Investigational Site Number : 1000003

    Sofia, 1113, Bulgaria

  • Investigational Site Number : 1240001

    Gatineau, Quebec, J8Y 1W2, Canada

  • Investigational Site Number : 2030001

    Jihlava, 58633, Czechia

  • Investigational Site Number : 2030002

    Hradec Králové, 50005, Czechia

  • Investigational Site Number : 2030003

    Brno, 65691, Czechia

  • Investigational Site Number : 2030004

    Teplice, 415 29, Czechia

  • Investigational Site Number : 2030005

    Ostrava - Poruba, 70852, Czechia

  • Investigational Site Number : 2500006

    Calais, 62107, France

  • Investigational Site Number : 2760004

    Münster, 48149, Germany

  • Investigational Site Number : 2760012

    Leipzig, 04103, Germany

  • Investigational Site Number : 6430001

    Moscow, 127015, Russia

  • Investigational Site Number : 6430002

    Kazan', 420032, Russia

  • Investigational Site Number : 6430003

    Saint Petersburg, 194044, Russia

  • Investigational Site Number : 6430004

    Saint Petersburg, 197110, Russia

  • Investigational Site Number : 6430005

    Saint Petersburg, 197022, Russia

  • Investigational Site Number : 6430006

    Moscow, 117997, Russia

  • Investigational Site Number : 6430007

    Moscow, 117556, Russia

  • Investigational Site Number : 6430008

    Tyumen, 625000, Russia

  • Investigational Site Number : 7240002

    Vigo, 36312, Spain

  • Investigational Site Number : 7240004

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7920001

    İzmit, 41380, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Mersin, 33070, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Istanbul, 34265, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Eskişehir, 26040, Turkey (Türkiye)

  • Investigational Site Number : 8040002

    Kyiv, 01135, Ukraine

  • Investigational Site Number : 8040003

    Odesa, 65025, Ukraine

  • Investigational Site Number : 8040004

    Lviv, 79013, Ukraine

  • Investigational Site Number : 8040005

    Vinnytsia, 21001, Ukraine

  • Investigational Site Number : 8040006

    Dnipro, 49089, Ukraine

  • Investigational Site Number : 8040008

    Ivano-Frankivsk, 76493, Ukraine

  • Investigational Site Number : 8040010

    Dnipro, 49005, Ukraine

  • Medical College of Wisconsin- Site Number : 8400006

    Milwaukee, Wisconsin, 53226, United States

  • The Neurological Institute Site Number : 8400004

    Charlotte, North Carolina, 28204, United States

  • University of South Florida Site Number : 8400001

    Tampa, Florida, 33612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.