Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis
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:
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Conditions:
Multiple Sclerosis
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Age: Between 18 Years - 55 Years
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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 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.
Updated on
21 Feb 2024.
Study ID: NCT04879628