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Multiple SclerosisPhase 2NCT04879628

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

A Phase 2 study testing SAR441344 IV, SAR441344 SC and MRI contrast-enhancing preparations in people with Multiple Sclerosis, run by Sanofi at 37 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
SAR441344 IV, SAR441344 SC and MRI contrast-enhancing preparations
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
37 sitesin 10 countries
Study dates
7 Jun 2021to 23 Aug 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

37 sites in 10 countries.

37 sites in 10 countries

Russia8 sites

  • Investigational Site Number : 6430002

    Kazan', 420032

  • Investigational Site Number : 6430007

    Moscow, 117556

  • Investigational Site Number : 6430006

    Moscow, 117997

  • Investigational Site Number : 6430001

    Moscow, 127015

  • Investigational Site Number : 6430003

    Saint Petersburg, 194044

  • Investigational Site Number : 6430005

    Saint Petersburg, 197022

  • Investigational Site Number : 6430004

    Saint Petersburg, 197110

  • Investigational Site Number : 6430008

    Tyumen, 625000

Other trials in Russia

Ukraine7 sites

  • Investigational Site Number : 8040010

    Dnipro, 49005

  • Investigational Site Number : 8040006

    Dnipro, 49089

  • Investigational Site Number : 8040008

    Ivano-Frankivsk, 76493

  • Investigational Site Number : 8040002

    Kyiv, 01135

  • Investigational Site Number : 8040004

    Lviv, 79013

  • Investigational Site Number : 8040003

    Odesa, 65025

  • Investigational Site Number : 8040005

    Vinnytsia, 21001

Other trials in Ukraine

Czechia5 sites

  • Investigational Site Number : 2030003

    Brno, 65691

  • Investigational Site Number : 2030002

    Hradec Králové, 50005

  • Investigational Site Number : 2030001

    Jihlava, 58633

  • Investigational Site Number : 2030005

    Ostrava - Poruba, 70852

  • Investigational Site Number : 2030004

    Teplice, 415 29

Other trials in Czechia

United States4 sites

  • The Neurological Institute Site Number : 8400004

    Charlotte, North Carolina, 28204

  • Medical College of Wisconsin- Site Number : 8400006

    Milwaukee, Wisconsin, 53226

  • Center for Neurology and Spine- Site Number : 8400007

    Phoenix, Arizona, 85032

  • University of South Florida Site Number : 8400001

    Tampa, Florida, 33612

Other trials in United States

Turkey (Türkiye)4 sites

  • Investigational Site Number : 7920004

    Eskişehir, 26040

  • Investigational Site Number : 7920003

    Istanbul, 34265

  • Investigational Site Number : 7920001

    İzmit, 41380

  • Investigational Site Number : 7920002

    Mersin, 33070

Other trials in Turkey (Türkiye)

Bulgaria3 sites

  • Investigational Site Number : 1000002

    Pleven, 5809

  • Investigational Site Number : 1000003

    Sofia, 1113

  • Investigational Site Number : 1000001

    Sofia, 1407

Other trials in Bulgaria

Germany2 sites

  • Investigational Site Number : 2760012

    Leipzig, 04103

  • Investigational Site Number : 2760004

    Münster, 48149

Other trials in Germany

Spain2 sites

  • Investigational Site Number : 7240004

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7240002

    Vigo, 36312

Other trials in Spain

Canada1 site

  • Investigational Site Number : 1240001

    Gatineau, Quebec, J8Y 1W2

Other trials in Canada

France1 site

  • Investigational Site Number : 2500006

    Calais, 62107

Other trials in France

About this study

Official title: 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
Read the 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.

Being tested
SAR441344 IV, placebo IV, SAR441344 SC, placebo SC, 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.

  • SAR441344 IVDrug

    Pharmaceutical form: Solution Route of administration: IV infusion

  • placebo IVDrug

    Pharmaceutical form: Solution Route of administration: IV infusion

  • SAR441344 SCDrug

    Pharmaceutical form: Solution Route of administration: SC injection

  • placebo SCDrug

    Pharmaceutical form: Solution Route of administration: SC injection

  • MRI contrast-enhancing preparationsDrug

    gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem

Study groups in NCT04879628
Study groupRoleWhat they receive
Intravenous (IV) SAR441344ExperimentalSAR441344 IV
Receives: Drug: SAR441344 IV; Drug: MRI contrast-enhancing preparations
IV PlaceboPlacebo comparatorPlacebo IV
Receives: Drug: placebo IV; Drug: MRI contrast-enhancing preparations
Subcutaneous (SC) SAR441344ExperimentalSAR441344 SC
Receives: Drug: SAR441344 SC; Drug: MRI contrast-enhancing preparations
SC PlaceboPlacebo comparatorPlacebo SC
Receives: Drug: placebo SC; Drug: MRI contrast-enhancing preparations

What is being measured

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

  1. 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)

    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.

    Measured: Week 8 and Week 12

Secondary outcomes (7)

  1. Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8

    Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8.

    Measured: Week 8 and Week 12

  2. Mean Total Number of GdE T1 Lesions at Week 12

    Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12.

    Measured: Baseline (Day 1) and Week 12

  3. Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)

    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.

    Measured: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)

  4. Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344

    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.

    Measured: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)

  5. Maximum Plasma Concentration (Cmax) of SAR441344

    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.

    Measured: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)

  6. Time to Maximum Plasma Concentration (Tmax) of SAR441344

    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.

    Measured: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)

  7. Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344

    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.

    Measured: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)

Timeline

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

  1. First posted10 May 2021
  2. Study start7 Jun 2021
  3. Primary completion21 Sep 2022
  4. Study completion23 Aug 2027 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04879628
Sponsor's protocol ID
ACT16877
Other IDs
U1111-1260-3962, 2024-513527-17-00, 2020-004785-19
Status last verified
Sep 2026
First submitted
6 May 2021
Last updated
28 Sep 2026
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

Publications

  • Vermersch P, Granziera C, Mao-Draayer Y, Cutter G, Kalbus O, Staikov I, Dufek M, Saubadu S, Bejuit R, Truffinet P, Djukic B, Wallstroem E, Giovannoni G; Frexalimab Phase 2 Trial Group. Inhibition of CD40L with Frexalimab in Multiple Sclerosis. N Engl J Med. 2024 Feb 15;390(7):589-600. doi: 10.1056/NEJMoa2309439.

    PubMed 38354138

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR441344 IV, SAR441344 SC and MRI contrast-enhancing preparations in people with Multiple Sclerosis, run by Sanofi at 37 sites in 10 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 6 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Russia, Ukraine, Czechia, United States, Turkey (Türkiye) and 5 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). 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 NCT04879628, which also lists 1 linked publication.

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 28 Sep 2026.

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