proof-of-concept study for sar441344 (frexalimab) in relapsing multiple sclerosis

Conditions: Multiple Sclerosis

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 sar441344

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:
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.