Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

September 11, 2025 updated by: Sanofi

A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

Primary Objective:

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions

Secondary Objective:

  • To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures
  • To evaluate the safety and tolerability of SAR441344
  • To evaluate pharmacokinetics of SAR441344

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Pleven, Bulgaria, 5809
        • Investigational Site Number : 1000002
      • Sofia, Bulgaria, 1407
        • Investigational Site Number : 1000001
      • Sofia, Bulgaria, 1113
        • Investigational Site Number : 1000003
  • Canada
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 1W2
        • Investigational Site Number : 1240001
  • Czechia
      • Brno, Czechia, 65691
        • Investigational Site Number : 2030003
      • Hradec Králové, Czechia, 50005
        • Investigational Site Number : 2030002
      • Jihlava, Czechia, 58633
        • Investigational Site Number : 2030001
      • Ostrava - Poruba, Czechia, 70852
        • Investigational Site Number : 2030005
      • Teplice, Czechia, 415 29
        • Investigational Site Number : 2030004
  • France
      • Calais, France, 62107
        • Investigational Site Number : 2500006
  • Germany
      • Leipzig, Germany, 04103
        • Investigational Site Number : 2760012
      • Münster, Germany, 48149
        • Investigational Site Number : 2760004
  • Russia
      • Kazan', Russia, 420032
        • Investigational Site Number : 6430002
      • Moscow, Russia, 117556
        • Investigational Site Number : 6430007
      • Moscow, Russia, 117997
        • Investigational Site Number : 6430006
      • Moscow, Russia, 127015
        • Investigational Site Number : 6430001
      • Saint Petersburg, Russia, 194044
        • Investigational Site Number : 6430003
      • Saint Petersburg, Russia, 197022
        • Investigational Site Number : 6430005
      • Saint Petersburg, Russia, 197110
        • Investigational Site Number : 6430004
      • Tyumen, Russia, 625000
        • Investigational Site Number : 6430008
  • Spain
      • Vigo, Spain, 36312
        • Investigational Site Number : 7240002
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Investigational Site Number : 7240004
  • Turkey (Türkiye)
      • Eskişehir, Turkey (Türkiye), 26040
        • Investigational Site Number : 7920004
      • Istanbul, Turkey (Türkiye), 34265
        • Investigational Site Number : 7920003
      • Mersin, Turkey (Türkiye), 33070
        • Investigational Site Number : 7920002
      • İzmit, Turkey (Türkiye), 41380
        • Investigational Site Number : 7920001
  • Ukraine
      • Dnipro, Ukraine, 49005
        • Investigational Site Number : 8040010
      • Dnipro, Ukraine, 49089
        • Investigational Site Number : 8040006
      • Ivano-Frankivsk, Ukraine, 76493
        • Investigational Site Number : 8040008
      • Kyiv, Ukraine, 01135
        • Investigational Site Number : 8040002
      • Lviv, Ukraine, 79013
        • Investigational Site Number : 8040004
      • Odesa, Ukraine, 65025
        • Investigational Site Number : 8040003
      • Vinnytsia, Ukraine, 21001
        • Investigational Site Number : 8040005
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Center for Neurology and Spine- Site Number : 8400007
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida Site Number : 8400001
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • The Neurological Institute Site Number : 8400004
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin- Site Number : 8400006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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 (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
  • The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
  • Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed informed consent.

Exclusion criteria:

  • The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
  • The participant had conditions or situations that would adversely affect participation in this study.
  • The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
  • History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
  • Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.
  • The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.
  • The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.
  • The participant had an EDSS score >5.5 at the first screening visit.
  • The participant had a relapse in the 30 days prior to randomization.
  • Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
  • Abnormal laboratory test(s) at Screening.
  • Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention.
  • Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: IV Placebo
Placebo IV
Drug: placebo IV
Pharmaceutical form: Solution Route of administration: IV infusion
Drug: MRI contrast-enhancing preparations
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem
Placebo Comparator: SC Placebo
Placebo SC
Drug: placebo SC
Pharmaceutical form: Solution Route of administration: SC injection
Drug: MRI contrast-enhancing preparations
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem
Experimental: Intravenous (IV) SAR441344
SAR441344 IV
Drug: SAR441344 IV
Pharmaceutical form: Solution Route of administration: IV infusion
Drug: MRI contrast-enhancing preparations
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem
Experimental: Subcutaneous (SC) SAR441344
SAR441344 SC
Drug: SAR441344 SC
Pharmaceutical form: Solution Route of administration: SC injection
Drug: MRI contrast-enhancing preparations
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)
Time Frame: Week 8 and Week 12
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
Week 8 and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8
Time Frame: Week 8 and Week 12
Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8.
Week 8 and Week 12
Mean Total Number of GdE T1 Lesions at Week 12
Time Frame: Baseline (Day 1) and Week 12
Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12.
Baseline (Day 1) and Week 12
Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344
Time Frame: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
Blood samples were collected at specified timepoints to assess the presence of ADAs against SAR441344. Treatment-emergent ADA was defined as at least 1 treatment-induced/boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA are presented.
From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
Maximum Plasma Concentration (Cmax) of SAR441344
Time Frame: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Blood samples were collected at the specified timepoints for the assessment of Cmax. Cmax was assessed by a Bayesian approach using the population pharmacokinetic (PK) model.
After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Time to Maximum Plasma Concentration (Tmax) of SAR441344
Time Frame: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Blood samples were collected at the specified timepoints for the assessment of tmax. tmax was assessed by a Bayesian approach using the population PK model.
After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344
Time Frame: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Blood samples were collected at the specified timepoints for the assessment of AUC0-tau. AUC0-tau was assessed by a Bayesian approach using the population PK model.
After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ACT16877
  • 2020-004785-19 (EudraCT Number)
  • U1111-1260-3962 (Registry Identifier: ICTRP)
  • 2024-513527-17-00 (Registry Identifier: CTIS)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on SAR441344 IV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings