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

Investigation of an Investigational Medication in Relapsing Multiple Sclerosis

Not Recruiting
18 years - 55 years
All
Phase 2
129 participants needed

Study Overview

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 Details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Multiple Sclerosis
  • Age: 18 years - 55 years
  • Gender: All

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.

This study investigates the effects of an investigational medication on individuals with relapsing multiple sclerosis (RMS), which includes relapsing-remitting MS and secondary progressive MS with relapses. This study aims to determine if the investigational medication can reduce the number of new active brain lesions, which are areas of damage in the brain visible on MRI scans.

Participants in this study will undergo procedures such as MRI scans to monitor brain lesions and other disease activities. Safety and tolerability will also be assessed, alongside the pharmacokinetics, which is how the investigational medication is absorbed, distributed, metabolized, and excreted in the body. These procedures will help evaluate the overall effectiveness and safety of the investigational medication.

  • Who can participate: Adults aged 18 to 55 years with a diagnosis of relapsing multiple sclerosis, who have experienced recent relapses or have active brain lesions, may be eligible. Participants must meet specific health criteria, including body weight and BMI requirements, and must not have primary progressive MS or certain medical conditions.
  • Study details: Participants will receive the investigational medication and undergo regular MRI scans to assess the impact on brain lesions. The study will also monitor participants for safety and tolerability. A placebo, an inactive substance that looks like the investigational medicine but does not contain any medicine, may be used for comparison.
  • Study timelines: The study will last 320 weeks.
Updated on 30 Sep 2025. Study ID: NCT04879628