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

NCT ID: NCT04879628

Last Updated: 2025-09-30

Study Results

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2027-08-23

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intravenous (IV) SAR441344

SAR441344 IV

Group Type EXPERIMENTAL

SAR441344 IV

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: IV infusion

MRI contrast-enhancing preparations

Intervention Type DRUG

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

IV Placebo

Placebo IV

Group Type PLACEBO_COMPARATOR

placebo IV

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: IV infusion

MRI contrast-enhancing preparations

Intervention Type DRUG

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

Subcutaneous (SC) SAR441344

SAR441344 SC

Group Type EXPERIMENTAL

SAR441344 SC

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: SC injection

MRI contrast-enhancing preparations

Intervention Type DRUG

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

SC Placebo

Placebo SC

Group Type PLACEBO_COMPARATOR

placebo SC

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: SC injection

MRI contrast-enhancing preparations

Intervention Type DRUG

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

Interventions

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SAR441344 IV

Pharmaceutical form: Solution Route of administration: IV infusion

Intervention Type DRUG

placebo IV

Pharmaceutical form: Solution Route of administration: IV infusion

Intervention Type DRUG

SAR441344 SC

Pharmaceutical form: Solution Route of administration: SC injection

Intervention Type DRUG

placebo SC

Pharmaceutical form: Solution Route of administration: SC injection

Intervention Type DRUG

MRI contrast-enhancing preparations

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Center for Neurology and Spine- Site Number : 8400007

Phoenix, Arizona, United States

Site Status

University of South Florida Site Number : 8400001

Tampa, Florida, United States

Site Status

The Neurological Institute Site Number : 8400004

Charlotte, North Carolina, United States

Site Status

Medical College of Wisconsin- Site Number : 8400006

Milwaukee, Wisconsin, United States

Site Status

Investigational Site Number : 1000002

Pleven, , Bulgaria

Site Status

Investigational Site Number : 1000003

Sofia, , Bulgaria

Site Status

Investigational Site Number : 1000001

Sofia, , Bulgaria

Site Status

Investigational Site Number : 1240001

Gatineau, Quebec, Canada

Site Status

Investigational Site Number : 2030003

Brno, , Czechia

Site Status

Investigational Site Number : 2030002

Hradec Králové, , Czechia

Site Status

Investigational Site Number : 2030001

Jihlava, , Czechia

Site Status

Investigational Site Number : 2030005

Ostrava - Poruba, , Czechia

Site Status

Investigational Site Number : 2030004

Teplice, , Czechia

Site Status

Investigational Site Number : 2500006

Calais, , France

Site Status

Investigational Site Number : 2760012

Leipzig, , Germany

Site Status

Investigational Site Number : 2760004

Münster, , Germany

Site Status

Investigational Site Number : 6430002

Kazan', , Russia

Site Status

Investigational Site Number : 6430007

Moscow, , Russia

Site Status

Investigational Site Number : 6430006

Moscow, , Russia

Site Status

Investigational Site Number : 6430001

Moscow, , Russia

Site Status

Investigational Site Number : 6430003

Saint Petersburg, , Russia

Site Status

Investigational Site Number : 6430005

Saint Petersburg, , Russia

Site Status

Investigational Site Number : 6430004

Saint Petersburg, , Russia

Site Status

Investigational Site Number : 6430008

Tyumen, , Russia

Site Status

Investigational Site Number : 7240004

Barcelona, Barcelona [Barcelona], Spain

Site Status

Investigational Site Number : 7240002

Vigo, , Spain

Site Status

Investigational Site Number : 7920004

Eskişehir, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920003

Istanbul, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920001

İzmit, , Turkey (Türkiye)

Site Status

Investigational Site Number : 7920002

Mersin, , Turkey (Türkiye)

Site Status

Investigational Site Number : 8040010

Dnipro, , Ukraine

Site Status

Investigational Site Number : 8040006

Dnipro, , Ukraine

Site Status

Investigational Site Number : 8040008

Ivano-Frankivsk, , Ukraine

Site Status

Investigational Site Number : 8040002

Kyiv, , Ukraine

Site Status

Investigational Site Number : 8040004

Lviv, , Ukraine

Site Status

Investigational Site Number : 8040003

Odesa, , Ukraine

Site Status

Investigational Site Number : 8040005

Vinnytsia, , Ukraine

Site Status

Countries

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United States Bulgaria Canada Czechia France Germany Russia Spain Turkey (Türkiye) Ukraine

References

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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.

Reference Type DERIVED
PMID: 38354138 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1260-3962

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-513527-17-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-004785-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACT16877

Identifier Type: -

Identifier Source: org_study_id

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