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Comparing under-the-skin versus intravenous frexalimab for adults with multiple sclerosis

A Randomized, Phase 3, Open-label Study to Investigate Pharmacokinetics, Safety, and Efficacy of Subcutaneous Compared to Intravenous Frexalimab in Adult Participants With Multiple Sclerosis

Phase 3 Interventional Sanofi · NCT07325292

This will test whether subcutaneous frexalimab given every 4 weeks works as well as intravenous frexalimab every 4 weeks for adults with relapsing MS or non-relapsing secondary progressive MS.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsfrexalimab
Locations18 sites (Cullman, Alabama and 17 other locations)
Trial IDNCT07325292 on ClinicalTrials.gov

What this trial studies

This is a randomized, open-label, parallel Phase 3 comparison of subcutaneous (SC) versus intravenous (IV) frexalimab given every 4 weeks in adults with relapsing multiple sclerosis (RMS) or non-relapsing secondary progressive MS (nrSPMS). Participants are assigned to one of two arms and treated over a 48-week intervention period (Parts A and B) with an optional Part C extension until a long-term safety study begins; follow-up after treatment discontinuation lasts 6 months. The protocol includes more frequent on-site visits for the SC arm and regular MRI monitoring, with eligibility defined by 2017 McDonald criteria, age ranges for each group, and disability/activity requirements. Safety, tolerability, and clinical and radiologic outcomes will be compared between the routes of administration.

Who should consider this trial

Good fit: Adults diagnosed with RMS or nrSPMS per the 2017 McDonald criteria who meet the age limits (commonly 18–55 for RMS and up to 60 for nrSPMS), have the required recent relapse or MRI activity (for RMS), and meet baseline disability criteria are the ideal candidates.

Not a fit: People with more advanced disability outside the study EDSS limits, progressive disease not meeting the nrSPMS definition, contraindications to monoclonal antibody therapy, or inability to attend required on-site visits are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, subcutaneous dosing could provide similar clinical benefit with easier administration and fewer or shorter clinic visits compared with IV dosing.

How similar studies have performed: Other MS treatments have successfully moved from IV to subcutaneous delivery (for example, ofatumumab), supporting the plausibility of similar effectiveness, though frexalimab-specific phase 3 data are needed.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Cullman, Alabama and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Sclerosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.