Proof-of-concept Study for SAR441344 in Relapsing Multiple Sclerosis

Brief description of study

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

The duration of each participant will be no longer than 116 weeks in both parts of the study, including 4 weeks of screening, at maximum 88 weeks of treatment and 24 weeks of follow-up.

Clinical Study Identifier: NCT04879628

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

  • Conditions: Multiple Sclerosis
  • Age: Between 18 Years - 55 Years
  • Gender: Male or Female

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 has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
  • The participant has conditions or situations that would adversely affect participation in this study.
  • The participant has 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 has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.
  • The participant has taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.
  • The participant has an EDSS score >5.5 at the first screening visit.
  • The participant has 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.

Last updated on 09 May 2022

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