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

NCT07325292 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: EFC180982024-519304-28U1111-1306-7563
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 18

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• 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

• 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

• Incidence of ADAs over time(part A)

  Until Week 96

Study Arms (2)

Frexalimab SC

EXPERIMENTAL

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; Drug: MRI contrast-enhancing preparations

Frexalimab IV

EXPERIMENTAL

Frexalimab IV

Drug: Frexalimab; Drug: MRI contrast-enhancing preparations

Interventions

Frexalimab DRUG

Pharmaceutical form:Solution for injection-Route of administration:SC injection

Also known as: SAR441344

Frexalimab SC

MRI contrast-enhancing preparations DRUG

Route of administration:IV injection

Frexalimab IV; Frexalimab SC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• documented relapse within the previous year OR
• documented relapses within the previous 2 years, OR
• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (18)

North Central Neurology Associates- Site Number : 8401100

Cullman, Alabama, 35058, United States

RECRUITING

Alabama Neurology Associates- Site Number : 8400115

Homewood, Alabama, 35209, United States

RECRUITING

Perseverance Research Center- Site Number : 8400138

Scottsdale, Arizona, 85253, United States

RECRUITING

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

West Hollywood, California, 90048, United States

RECRUITING

Neurology of Central Florida- Site Number : 8400147

Altamonte Springs, Florida, 32714, United States

RECRUITING

Aqualane Clinical Research- Site Number : 8400026

Naples, Florida, 34105, United States

RECRUITING

Neurology Associates of Ormond Beach- Site Number : 8400086

Ormond Beach, Florida, 32174, United States

RECRUITING

Palm Beach Neurology- Site Number : 8400105

West Palm Beach, Florida, 33407, United States

RECRUITING

Joi Life Wellness Group LLC- Site Number : 8400192

Smyrna, Georgia, 30080, United States

RECRUITING

Michigan Institute for Neurological Disorders- Site Number : 8400004

Farmington Hills, Michigan, 48334, United States

RECRUITING

Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

Charlotte, North Carolina, 28210, United States

RECRUITING

Raleigh Neurology Associates- Site Number : 8400014

Raleigh, North Carolina, 27607, United States

RECRUITING

Hope Neurology- Site Number : 8400019

Knoxville, Tennessee, 37922, United States

RECRUITING

ANESC Research- Site Number : 8400187

El Paso, Texas, 79912, United States

RECRUITING

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

Plano, Texas, 75024, United States

RECRUITING

Investigational Site Number : 0560001

Bruges, 8000, Belgium

RECRUITING

Investigational Site Number : 0560007

Kortrijk, 8500, Belgium

RECRUITING

Investigational Site Number : 0560005

Overpelt, 3900, Belgium

RECRUITING

Related Links

• EFC18098 Plain Language Results Summary

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 8, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (15); BE (3)