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

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

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.

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.