Phase 2 Study of SAR441344 (Frexalimab) in Human MS Patients

study phasePatient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.

subjects"populationDescription": "The safety population included all randomized participants who took at least 1 dose (regardless of the amount) of study drug.",

randomized"populationDescription": "The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint.

controlled"description": "An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.

peer reviewed"eligibilityCriteria": "Inclusion criteria:\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* 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.\n* 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.\n* 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.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent.\n\nExclusion criteria:\n\n* The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.\n* The participant had conditions or situations that would adversely affect participation in this study.\n* The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.\n* 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.\n* Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.\n* The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.\n* The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.\n* The participant had an EDSS score \\>5.5 at the first screening visit.\n* The participant had a relapse in the 30 days prior to randomization.\n* Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.\n* Abnormal laboratory test(s) at Screening.\n* 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.\n* Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",

intervention"eligibilityCriteria": "Inclusion criteria:\n\n* Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n* 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.\n* 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.\n* 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.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent.\n\nExclusion criteria:\n\n* The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.\n* The participant had conditions or situations that would adversely affect participation in this study.\n* The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.\n* 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.\n* Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.\n* The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.\n* The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.\n* The participant had an EDSS score \\>5.5 at the first screening visit.\n* The participant had a relapse in the 30 days prior to randomization.\n* Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.\n* Abnormal laboratory test(s) at Screening.\n* 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.\n* Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",

comparator"populationDescription": "The safety population included all randomized participants who took at least 1 dose (regardless of the amount) of study drug.",

findings"briefSummary": "Primary Objective:\n\nTo determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions\n\nSecondary Objective:\n\n* To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures\n* To evaluate the safety and tolerability of SAR441344\n* To evaluate pharmacokinetics of SAR441344",

limitationsTrial registry record. Publication date: unknown. Sponsor-submitted results are available; this does not establish peer review.