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MS patients may soon swap IV drips for quick shots

NCT ID NCT07325292

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 5 times

Summary

This Phase 3 trial tests whether a simple injection of frexalimab every 4 weeks works as well as the standard IV infusion for adults with relapsing or non-active progressive multiple sclerosis. About 160 participants will be randomly assigned to one of the two methods. The study lasts 48 weeks and aims to see if the injection provides similar drug levels 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
frexalimab
What this could lead to
If successful, this could show that a simple injection works as well as an IV infusion for controlling multiple sclerosis, making treatment more convenient.
What could go wrong
This is an early-stage Phase 3 trial with only 160 participants, so results may not apply to everyone. The study compares two ways of giving the same drug, not against a placebo, so it won't prove the drug itself works.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Nov 2028

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 60 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: The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group: Group A (RMS) * 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 in accordance with the 2017 revised McDonald criteria. * The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (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. Group B (nrSPMS) * Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria * The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent. * The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013. * The participant must have documented evidence of disability progression observed during the 12 months before screening. * The participant must have an absence of clinical relapses for at least 24 months. * The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit). Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply: \- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria. * The participant has a history of infection or may be at risk for infection: * Fever within 28 days of the Screening Visit * Presence of psychiatric disturbance or substance abuse * History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment. * Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia. * A history or presence of disease that can mimic MS symptoms. * The participant has a contraindication for MRI. 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 secondary progressive multiple sclerosis

As listed by the trial registrant

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

Multiple sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    40 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ANESC Research- Site Number : 8400187

    RECRUITING

    El Paso, Texas, 79912, United States

  • Advanced Neurology of Colorado- Site Number : 8400148

    RECRUITING

    Fort Collins, Colorado, 80528, United States

  • Alabama Neurology Associates- Site Number : 8400115

    RECRUITING

    Homewood, Alabama, 35209, United States

  • Aqualane Clinical Research- Site Number : 8400026

    RECRUITING

    Naples, Florida, 34105, United States

  • Azienda Ospedaliera San Camillo Forlanini Site Number : 3800001

    RECRUITING

    Roma, 00152, Italy

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia Site Number : 3800019

    RECRUITING

    Foggia, 71122, Italy

  • Baltimore Veterans Affairs Medical Center- Site Number : 8400163

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195

    RECRUITING

    Phoenix, Arizona, 85032, United States

  • Consultants in Neurology- Site Number : 8400020

    RECRUITING

    Northbrook, Illinois, 60062, United States

  • Fondazione Policlinico Universitario Campus Bio-Medico Site Number : 3800038

    RECRUITING

    Roma, 00128, Italy

  • Holy Name Medical Center- Site Number : 8400101

    RECRUITING

    Teaneck, New Jersey, 07666, United States

  • Hope Neurology- Site Number : 8400019

    RECRUITING

    Knoxville, Tennessee, 37922, United States

  • Investigational Site Number : 0560001

    RECRUITING

    Bruges, 8000, Belgium

  • Investigational Site Number : 0560005

    RECRUITING

    Overpelt, 3900, Belgium

  • Investigational Site Number : 0560006

    RECRUITING

    Ghent, 9000, Belgium

  • Investigational Site Number : 0560007

    RECRUITING

    Kortrijk, 8500, Belgium

  • Investigational Site Number : 0560008

    RECRUITING

    Brussels, 1200, Belgium

  • Investigational Site Number : 1560004

    RECRUITING

    Chengdu, 610041, China

  • Investigational Site Number : 1560005

    RECRUITING

    Beijing, 100034, China

  • Investigational Site Number : 1560010

    RECRUITING

    Jiazhuang, 050000, China

  • Investigational Site Number : 1561029

    RECRUITING

    Chengdu, 610072, China

  • Investigational Site Number : 3800016

    RECRUITING

    Milan, Milano, 20133, Italy

  • Investigational Site Number : 3920001

    RECRUITING

    Kyoto, 616-8255, Japan

  • Investigational Site Number : 3920008

    RECRUITING

    Yahaba, Iwate, 028-3695, Japan

  • Investigational Site Number : 3920012

    RECRUITING

    Tokyo, 160-8582, Japan

  • Investigational Site Number : 3920017

    RECRUITING

    Sapporo, Hokkaido, 063-0005, Japan

  • Joi Life Wellness Group LLC- Site Number : 8400192

    RECRUITING

    Smyrna, Georgia, 30080, United States

  • Michigan Institute for Neurological Disorders- Site Number : 8400004

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Neurology Associates of Ormond Beach- Site Number : 8400086

    RECRUITING

    Ormond Beach, Florida, 32174, United States

  • Neurology of Central Florida- Site Number : 8400147

    RECRUITING

    Altamonte Springs, Florida, 32714, United States

  • North Central Neurology Associates- Site Number : 8401100

    RECRUITING

    Cullman, Alabama, 35058, United States

  • North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082

    RECRUITING

    Plano, Texas, 75024, United States

  • North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083

    RECRUITING

    Plano, Texas, 75024, United States

  • Palm Beach Neurology- Site Number : 8400105

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Perseverance Research Center- Site Number : 8400138

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

    RECRUITING

    Charlotte, North Carolina, 28210, United States

  • Private Practice - Dr. Regina Berkovich- Site Number : 8400005

    RECRUITING

    West Hollywood, California, 90048, United States

  • Raleigh Neurology Associates- Site Number : 8400014

    RECRUITING

    Raleigh, North Carolina, 27607, United States

  • The Boster Center for Multiple Sclerosis- Site Number : 8400006

    RECRUITING

    Columbus, Ohio, 43235, United States

  • The Ohio State University- Site Number : 8400009

    RECRUITING

    Columbus, Ohio, 43210, United States

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