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

NCT ID: NCT07325292

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2028-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Frexalimab SC

Frexalimab SC

Group Type: EXPERIMENTAL

Frexalimab

Intervention Type: DRUG

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

MRI contrast-enhancing preparations

Intervention Type: DRUG

Route of administration:IV injection

Frexalimab IV

Frexalimab IV

Group Type: EXPERIMENTAL

Frexalimab

Intervention Type: DRUG

Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

MRI contrast-enhancing preparations

Intervention Type: DRUG

Route of administration:IV injection

Interventions

Frexalimab

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

Intervention Type: DRUG

Frexalimab

Pharmaceutical form:Concentrate for solution for infusion-Route of administration:IV infusion

Intervention Type: DRUG

MRI contrast-enhancing preparations

Route of administration:IV injection

Intervention Type: DRUG

Other Intervention Names

SAR441344; SAR441344

Eligibility Criteria

Inclusion Criteria

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.
• 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.
• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

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

Role: CONTACT

Contact-US@sanofi.com

800-633-1610 ext. option 6

Other Identifiers

2024-519304-28

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1306-7563

Identifier Type: REGISTRY

Identifier Source: secondary_id

EFC18098

Identifier Type: -

Identifier Source: org_study_id