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

ClinicalTrials.gov ID: NCT07325292

Public ClinicalTrials.gov record NCT07325292. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 2:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 for participants receiving frexalimab SC or IV, 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 identification

NCT ID: NCT07325292
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Sanofi; Industry
Enrollment: 160 participants

Conditions and interventions

Conditions

Multiple Sclerosis

Interventions

Frexalimab Drug
MRI contrast-enhancing preparations Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 60 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 13, 2026
Primary completion: Jul 14, 2027
Completion: Nov 29, 2028
Last update posted: Aug 13, 2026

2026 – 2028

United States locations

U.S. sites: 22
U.S. states: 13
U.S. cities: 20

Facility	City	State	ZIP	Site status
North Central Neurology Associates- Site Number : 8401100	Cullman	Alabama	35058	Recruiting
Alabama Neurology Associates- Site Number : 8400115	Homewood	Alabama	35209	Recruiting
Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195	Phoenix	Arizona	85032	Recruiting
Perseverance Research Center- Site Number : 8400138	Scottsdale	Arizona	85253	Recruiting
Private Practice - Dr. Regina Berkovich- Site Number : 8400005	West Hollywood	California	90048	Recruiting
Advanced Neurology of Colorado- Site Number : 8400148	Fort Collins	Colorado	80528	Recruiting
Neurology of Central Florida- Site Number : 8400147	Altamonte Springs	Florida	32714	Recruiting
Aqualane Clinical Research- Site Number : 8400026	Naples	Florida	34105	Recruiting
Neurology Associates of Ormond Beach- Site Number : 8400086	Ormond Beach	Florida	32174	Recruiting
Palm Beach Neurology- Site Number : 8400105	West Palm Beach	Florida	33407	Recruiting
Joi Life Wellness Group LLC- Site Number : 8400192	Smyrna	Georgia	30080	Recruiting
Consultants in Neurology- Site Number : 8400020	Northbrook	Illinois	60062	Recruiting
Michigan Institute for Neurological Disorders- Site Number : 8400004	Farmington Hills	Michigan	48334	Recruiting
Holy Name Medical Center- Site Number : 8400101	Teaneck	New Jersey	07666	Recruiting
Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002	Charlotte	North Carolina	28210	Recruiting
Raleigh Neurology Associates- Site Number : 8400014	Raleigh	North Carolina	27607	Recruiting
The Ohio State University- Site Number : 8400009	Columbus	Ohio	43210	Recruiting
The Boster Center for Multiple Sclerosis- Site Number : 8400006	Columbus	Ohio	43235	Recruiting
Hope Neurology- Site Number : 8400019	Knoxville	Tennessee	37922	Recruiting
ANESC Research- Site Number : 8400187	El Paso	Texas	79912	Recruiting
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400082	Plano	Texas	75024	Recruiting
North Texas Institute of Neurology & Headache - Plano- Site Number : 8400083	Plano	Texas	75024	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07325292, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 13, 2026 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT07325292 live on ClinicalTrials.gov.

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