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

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

This is a randomized, open-label, parallel, Phase 3 study with 2-arms for treatment.

The purpose of this study is to evaluate SC administration of frexalimab every 4 weeks (q4w) compared to IV administration of frexalimab q4w in male and female participants with RMS and nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with MS are eligible for enrollment as long as they meet all the inclusion criteria and none of the exclusion criteria.

Study details include:

The study intervention duration will be 48 weeks (12 months) for Parts A and B combined. Optional Part C will last until the initiation of a long term safety study for Frexalimab.The follow up duration after the end of study intervention (in case of discontinuation) will be 6 months.

The number of scheduled visits (Parts A and B) will be 17 or 11 for participants receiving frexalimab SC or IV, respectively, with an on-site visit frequency of every month between Week 4 and Week 24 in Part A, then every 1 to 3 months in Part B, then every 6 months in Part C. Participants discontinuing treatment before the End of Study will have an additional 3 follow-up visits.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Frexalimab; Drug: Frexalimab; Drug: MRI contrast-enhancing preparations

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-Us@sanofi.com

Study Locations

• Belgium
  • Bruges, Belgium, 8000
    • Recruiting
    • Investigational Site Number : 0560001
  • Ghent, Belgium, 9000
    • Recruiting
    • Investigational Site Number : 0560006
  • Kortrijk, Belgium, 8500
    • Recruiting
    • Investigational Site Number : 0560007
  • Overpelt, Belgium, 3900
    • Recruiting
    • Investigational Site Number : 0560005
• China
  • Chengdu, China, 610041
    • Recruiting
    • Investigational Site Number : 1560004
  • Chengdu, China, 610072
    • Recruiting
    • Investigational Site Number : 1561029
  • Jiazhuang, China, 050000
    • Recruiting
    • Investigational Site Number : 1560010
• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 063-0005
      • Recruiting
      • Investigational Site Number : 3920017
• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
      • Recruiting
      • North Central Neurology Associates- Site Number : 8401100
    • Homewood, Alabama, United States, 35209
      • Recruiting
      • Alabama Neurology Associates- Site Number : 8400115
  • Arizona
    • Scottsdale, Arizona, United States, 85253
      • Recruiting
      • Perseverance Research Center- Site Number : 8400138
  • California
    • West Hollywood, California, United States, 90048
      • Recruiting
      • Private Practice - Dr. Regina Berkovich- Site Number : 8400005
  • Colorado
    • Fort Collins, Colorado, United States, 80528
      • Recruiting
      • Advanced Neurology of Colorado- Site Number : 8400148
  • Florida
    • Altamonte Springs, Florida, United States, 32714
      • Recruiting
      • Neurology of Central Florida- Site Number : 8400147
    • Naples, Florida, United States, 34105
      • Recruiting
      • Aqualane Clinical Research- Site Number : 8400026
    • Ormond Beach, Florida, United States, 32174
      • Recruiting
      • Neurology Associates of Ormond Beach- Site Number : 8400086
    • West Palm Beach, Florida, United States, 33407
      • Recruiting
      • Palm Beach Neurology- Site Number : 8400105
  • Georgia
    • Smyrna, Georgia, United States, 30080
      • Recruiting
      • Joi Life Wellness Group LLC- Site Number : 8400192
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Recruiting
      • Michigan Institute for Neurological Disorders- Site Number : 8400004
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Recruiting
      • Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002
    • Raleigh, North Carolina, United States, 27607
      • Recruiting
      • Raleigh Neurology Associates- Site Number : 8400014
  • Tennessee
    • Knoxville, Tennessee, United States, 37922
      • Recruiting
      • Hope Neurology- Site Number : 8400019
  • Texas
    • El Paso, Texas, United States, 79912
      • Recruiting
      • ANESC Research- Site Number : 8400187
    • Plano, Texas, United States, 75024
      • Recruiting
      • North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frexalimab IV	Drug: Frexalimab; Pharmaceutical form:Solution for injection-Route of administration:SC injection; Other Names: SAR441344; Drug: Frexalimab; Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion; Other Names: SAR441344; Drug: MRI contrast-enhancing preparations; Route of administration:IV injection
Experimental: Frexalimab SC; Frexalimab SC (home self-administration via on-body delivery system(OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement)	Drug: Frexalimab; Pharmaceutical form:Solution for injection-Route of administration:SC injection; Other Names: SAR441344; Drug: Frexalimab; Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion; Other Names: SAR441344; Drug: MRI contrast-enhancing preparations; Route of administration:IV injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the curve over the interval W20 to W24(part A)	AUCW20-W24	Until Week 24
Trough concentration at steady state(part A)	Ctrough,SS	Until Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and potentially clinically significant abnormality(PCSA) in laboratory tests, and vital signs during the study period	Until Week 96
Frexalimab plasma concentrations over time(part A)	Until Week 24
Pharmacokinetic parameters: Cmax(part A)	Until Week 24
Pharmacokinetic parameters: Tmax(part A)	Until Week 24
Incidence of ADAs over time(part A)	Until Week 96
Total number of Gd-enhancing T1 lesions at W12 and W24(part A)	At Week 12 and Week 24
Time to onset of confirmed disability worsening (CDW)/ confirmed disability progression(CDP) confirmed over 3 months	Until week 96
Medical device AEs, ADEs, SAEs, SADEs and device deficiencies throughout the study	Until week 96
Percentage of participants that prefer SC administration over IV administration assessed by Items 13 and 14 of the PESQ at Week 48 completed by participants that switched from IV to SC in Part B.	From week 24 to week 48
Total number of GdE T1 lesions at W48(part B)	At week 48
Total number of GdE T1 lesions at W96 and yearly thereafter.(part C)	At week 96 and yearly thereafter

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• EFC18098 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: EFC18098; 2024-519304-28 (Registry Identifier: CTIS); U1111-1306-7563 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No