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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• North Central Neurology Associates- Site Number : 8401100
  Cullman, Alabama, United States Recruiting
• Alabama Neurology Associates- Site Number : 8400115
  Homewood, Alabama, United States Recruiting
• Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195
  Phoenix, Arizona, United States Recruiting
• Perseverance Research Center- Site Number : 8400138
  Scottsdale, Arizona, United States Recruiting
• Center for Neurosciences - Tucson- Site Number : 8400194
  Tucson, Arizona, United States Recruiting
• Chemidox Clinical Trials- Site Number : 8401157
  Lancaster, California, United States Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.