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OpenTrials
Active, Not Recruiting

NCT Number: NCT04879628

Proof-of-concept Study for SAR441344 (Frexalimab) in 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational Site Number : 1000002, Pleven, Bulgaria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAR441344 IV

Drug

Pharmaceutical form: Solution Route of administration: IV infusion

Placebo IV

Drug

Pharmaceutical form: Solution Route of administration: IV infusion

SAR441344 SC

Drug

Pharmaceutical form: Solution Route of administration: SC injection

Placebo SC

Drug

Pharmaceutical form: Solution Route of administration: SC injection

MRI contrast-enhancing preparations

Drug

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

Primary outcomes

  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)

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2027
First posted
May 10, 2021
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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