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Multiple SclerosisPhase 3FrexciteNCT07325292

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

A Phase 3 study testing Frexalimab and MRI contrast-enhancing preparations in people with Multiple Sclerosis, run by Sanofi at 68 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
Frexalimab and MRI contrast-enhancing preparations
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
68 sitesin 7 countries
Study dates
14 Jan 2026to 30 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

68 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

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

800-633-1610 ext. option 6

Contact-US@sanofi.com

68 sites in 7 countries

United States34 sites, 34 recruiting

  • Abington Neurological Associates- Site Number : 8401065

    Abington, Pennsylvania, 19001

    Recruiting

  • Neurology of Central Florida- Site Number : 8400147

    Altamonte Springs, Florida, 32714

    Recruiting

  • Atlanta Neuroscience Institute- Site Number : 8400075

    Atlanta, Georgia, 30327

    Recruiting

  • Rocky Mountain Regional VA Medical Center- Site Number : 8400121

    Aurora, Colorado, 80045

    Recruiting

  • Baltimore Veterans Affairs Medical Center- Site Number : 8400163

    Baltimore, Maryland, 21201

    Recruiting

  • Piedmont HealthCare - Lake Norman Neurology- Site Number : 8400002

    Charlotte, North Carolina, 28210

    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

  • North Central Neurology Associates- Site Number : 8401100

    Cullman, Alabama, 35058

    Recruiting

  • ANESC Research- Site Number : 8400187

    El Paso, Texas, 79912

    Recruiting

  • Michigan Institute for Neurological Disorders- Site Number : 8400004

    Farmington Hills, Michigan, 48334

    Recruiting

  • Advanced Neurology of Colorado- Site Number : 8400148

    Fort Collins, Colorado, 80528

    Recruiting

  • Neurology Center of New England- Site Number : 8400164

    Foxborough, Massachusetts, 02035

    Recruiting

  • Norman Fixel Institute for Neurological Diseases (FIND)- Site Number : 8400054

    Gainesville, Florida, 32608

    Recruiting

  • Alabama Neurology Associates- Site Number : 8400115

    Homewood, Alabama, 35209

    Recruiting

  • Hope Neurology- Site Number : 8400019

    Knoxville, Tennessee, 37922

    Recruiting

  • Chemidox Clinical Trials- Site Number : 8401157

    Lancaster, California, 93534

    Recruiting

  • Medical College of Wisconsin - Milwaukee Campus- Site Number : 8400038

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Aqualane Clinical Research- Site Number : 8400026

    Naples, Florida, 34105

    Recruiting

  • Consultants in Neurology- Site Number : 8400020

    Northbrook, Illinois, 60062

    Recruiting

  • Orlando Health Neuroscience Institute - Downtown Pavilion- Site Number : 8400060

    Orlando, Florida, 32806

    Recruiting

  • Neurology Associates of Ormond Beach- Site Number : 8400086

    Ormond Beach, Florida, 32174

    Recruiting

  • Center for Neurology and Spine - Phoenix - East Bell Road- Site Number : 8400195

    Phoenix, Arizona, 85032

    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

  • Raleigh Neurology Associates- Site Number : 8400014

    Raleigh, North Carolina, 27607

    Recruiting

  • Neurology Center of San Antonio- Site Number : 8400099

    San Antonio, Texas, 78258

    Recruiting

  • Perseverance Research Center- Site Number : 8400138

    Scottsdale, Arizona, 85253

    Recruiting

  • Joi Life Wellness Group Llc- Site Number : 8400192

    Smyrna, Georgia, 30080

    Recruiting

  • University of South Florida- Site Number : 8400013

    Tampa, Florida, 33612

    Recruiting

  • Holy Name Medical Center- Site Number : 8400101

    Teaneck, New Jersey, 07666

    Recruiting

  • Center for Neurosciences - Tucson- Site Number : 8400194

    Tucson, Arizona, 85718

    Recruiting

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

    West Hollywood, California, 90048

    Recruiting

  • Palm Beach Neurology- Site Number : 8400105

    West Palm Beach, Florida, 33407

    Recruiting

Other trials in United States

China7 sites, 7 recruiting

  • Investigational Site Number : 1560005

    Beijing, 100034

    Recruiting

  • Investigational Site Number : 1560004

    Chengdu, 610041

    Recruiting

  • Investigational Site Number : 1561029

    Chengdu, 610072

    Recruiting

  • Investigational Site Number : 1560020

    Dongguan, 523000

    Recruiting

  • Investigational Site Number : 1560002

    Guangzhou, 510630

    Recruiting

  • Investigational Site Number : 1560010

    Jiazhuang, 050000

    Recruiting

  • Investigational Site Number : 1560014

    Shenyang, 110004

    Recruiting

Other trials in China

Italy7 sites, 7 recruiting

  • Investigational Site Number : 3801007

    Cagliari, 09126

    Recruiting

  • Azienda Ospedaliero-Universitaria Ospedali Riuniti di Foggia Site Number : 3800019

    Foggia, 71122

    Vincenzo Di Gioia, 0039 0881 733882, vincenzo_digioia.561582@unifg.it

    Emanuele D'Amico, Prof.

    Recruiting

  • Investigational Site Number : 3800016

    Milan, Milano, 20133

    Recruiting

  • Investigational Site Number : 3800037

    Montichiari, Brescia, 25018

    Recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico Site Number : 3800038

    Roma, 00128

    Felice Altieri, felice.altieri@policlinicocampus.it

    Fioravante Capone, Dr.

    Recruiting

  • Azienda Ospedaliera San Camillo Forlanini Site Number : 3800001

    Roma, 00152

    0039 06 58704272, CGasperini@scamilloforlanini.rm.it

    Claudio Gasperini, Prof.

    Recruiting

  • Investigational Site Number : 3800036

    Rozzano, Milano, 20089

    Recruiting

Other trials in Italy

Japan7 sites, 7 recruiting

  • Investigational Site Number : 3920015

    Higashi-Matsuyama, Saitama, 355-0005

    Recruiting

  • Investigational Site Number : 3920016

    Kodaira, Tokyo, 187-8551

    Recruiting

  • Investigational Site Number : 3920003

    Kōriyama, Fukushima, 963-8052

    Recruiting

  • Investigational Site Number : 3920001

    Kyoto, 616-8255

    Recruiting

  • Investigational Site Number : 3920017

    Sapporo, Hokkaido, 063-0005

    Recruiting

  • Investigational Site Number : 3920012

    Tokyo, 160-8582

    Recruiting

  • Investigational Site Number : 3920008

    Yahaba, Iwate, 028-3695

    Recruiting

Other trials in Japan

Belgium5 sites, 5 recruiting

  • Investigational Site Number : 0560001

    Bruges, 8000

    Recruiting

  • Investigational Site Number : 0560008

    Brussels, 1200

    Recruiting

  • Investigational Site Number : 0560006

    Ghent, 9000

    Recruiting

  • Investigational Site Number : 0560007

    Kortrijk, 8500

    Recruiting

  • Investigational Site Number : 0560005

    Overpelt, 3900

    Recruiting

Other trials in Belgium

Spain5 sites, 5 recruiting

  • Investigational Site Number : 7240010

    Barcelona, Catalunya [Cataluña], 08035

    Recruiting

  • Investigational Site Number : 7240023

    Madrid, 28007

    Recruiting

  • Investigational Site Number : 7240005

    Málaga, 29010

    Recruiting

  • Investigational Site Number : 7240001

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • Investigational Site Number : 7240014

    Vigo, Pontevedra [Pontevedra], 36312

    Recruiting

Other trials in Spain

Brazil3 sites, 3 recruiting

  • L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760003

    Brasília, Federal District, 70200-730

    Recruiting

  • Instituto de Neurologia de Curitiba - Ecoville- Site Number : 0760001

    Curitiba, Paraná, 81210-310

    Recruiting

  • Clínica Neurológica- Site Number : 0760007

    Joinville, Santa Catarina, 89202-165

    Recruiting

Other trials in Brazil

About this study

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

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.

Read more

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.

Being tested
Frexalimab, MRI contrast-enhancing preparations
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FrexalimabDrug

    Also called SAR441344

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

  • FrexalimabDrug

    Also called SAR441344

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

  • MRI contrast-enhancing preparationsDrug

    Route of administration:IV injection

Study groups in NCT07325292
Study groupRoleWhat they receive
Frexalimab SCExperimentalFrexalimab 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)
Receives: Drug: Frexalimab; Drug: MRI contrast-enhancing preparations
Frexalimab IVExperimentalFrexalimab IV
Receives: Drug: Frexalimab; Drug: MRI contrast-enhancing preparations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve over the interval W20 to W24(part A)

    AUCW20-W24

    Measured: Until Week 24

  2. Trough concentration at steady state(part A)

    Ctrough,SS

    Measured: Until Week 24

Secondary outcomes (11)

  1. Frexalimab plasma concentrations over time (part A for IV Arm Part A, B, C for SC arm)

    Measured: Until Week 24 for IV arm, Until EOS for SC arm ( until Week 96)

  2. Pharmacokinetic parameters: Cmax(part A)

    Measured: Until Week 24

  3. Pharmacokinetic parameters: Tmax(part A)

    Measured: Until Week 24

  4. 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

    Measured: Until Week 96

  5. Incidence of ADAs over time. (part A, B and C)

    Measured: through study completion, an average of 48 weeks

  6. Total number of Gd-enhancing T1 lesions at W12 and W24(part A)

    Measured: At Week 12 and Week 24

  7. Time to onset of confirmed disability worsening (CDW)/ confirmed disability progression(CDP) confirmed over 3 months

    Measured: Until week 96

  8. Medical device AEs, ADEs, SAEs, SADEs and device deficiencies throughout the study

    Measured: Until week 96

  9. 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.

    Measured: From week 24 to week 48

  10. Total number of GdE T1 lesions at W48(part B)

    Measured: At week 48

  11. Total number of GdE T1 lesions at W96 and yearly thereafter.(part C)

    Measured: At week 96 and yearly thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start14 Jan 2026
  3. Primary completion15 Jul 2027 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07325292
Sponsor's protocol ID
EFC18098
Other IDs
2024-519304-28, U1111-1306-7563
Acronym
Frexcite
Status last verified
Oct 2026
First submitted
23 Dec 2025
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Frexalimab and MRI contrast-enhancing preparations in people with Multiple Sclerosis, run by Sanofi at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, China, Italy, Japan, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the curve over the interval W20 to W24(part A) (time frame: Until Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07325292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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