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Frexalimab Study for Multiple Sclerosis

This study is looking at frexalimab, a medication for multiple sclerosis (MS). Researchers want to see if giving frexalimab as an injection under the skin (subcutaneous or SC) works as well as giving it through a vein (intravenous or IV). This is important because SC injections can be more convenient for patients. The study will compare these two ways of giving frexalimab every four weeks in adults aged 18 to 60 who have relapsing-remitting MS (RMS) or non-relapsing secondary progressive MS (nrSPMS). The main goals are to measure how much frexalimab is in the body and how it works over 24 weeks. The study is currently recruiting participants.

Study design
This is a randomized, open-label, parallel, Phase 3 study with two treatment groups, aiming to enroll 160 participants.
What's involved
You would receive frexalimab either by SC injection or IV infusion every four weeks for 48 weeks (about 12 months). There is an optional Part C that could extend your participation. You would also have a follow-up period of 6 months after treatment ends.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after their study intervention ends.

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NCT07325292

Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis

Recruiting
PHASE3Ages 18–60InterventionalTreatment
Sanofi
~160 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:FrexalimabMRI contrast-enhancing preparations

At a glance

Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the curve over the interval W20 to W24(part A)
Measured over Until Week 24
+1 more outcome measured

Conditions

Multiple Sclerosis

Explore related trials

Multiple Sclerosis

Where it's being run

38 sites across 20 states
Belgium5
Florida4
China4
Texas3
Italy3
Alabama2
Arizona2
North Carolina2

Who to contact

Trial Transparency email recommended (Toll free for US & Canada)
[email protected]
800-633-1610 · ext. option 6
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

Exclusion

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.

What this trial measures

  • Area under the curve over the interval W20 to W24(part A)Until Week 24

    AUCW20-W24

  • Trough concentration at steady state(part A)Until Week 24

    Ctrough,SS