Multiple Sclerosis Clinical Trial
Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions.
To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures.
To evaluate the safety and tolerability of SAR442168.
The total study duration was 24 weeks which included a screening period of 4 weeks, a treatment period of 16 weeks, and a follow-up period of up to 4 weeks. Participants who completed the Week 16 visit were proposed to be enrolled in a long-term extension safety and efficacy study to assess safety, tolerability and efficacy of SAR442168.
Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
Participant was diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria.
Participant must had at least 1 documented relapse within the previous year, OR greater than or equal to (>=) 2 documented relapses within the previous 2 years, OR >=1 active Gadolinium (Gd) enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
A female participant must had used a double contraception method including a highly effective method of birth control from inclusion and up to 2 months after the last study dose, except if she had undergone sterilization at least 3 months earlier or was postmenopausal. Menopause was defined as being amenorrheic for >=12 months with serum follicle-stimulating hormone (FSH) level greater than (>) 30 International Units per liters.
Male participants, whose partners were of childbearing potential (including breastfeeding women), must had accepted to use, during sexual intercourse, a double contraceptive method according to the following algorithm: (condom) plus (intrauterine device or hormonal contraceptive) from inclusion up to 3 months after the last dose.
Male participants whose partners were pregnant must had used, during sexual intercourse, a condom from inclusion up to 3 months after the last dose.
Male participants had agreed not to donate sperm from the inclusion up to 3 months after the last dose.
Participant had given written informed consent prior to undertaking any study-related procedure.
The participant had been diagnosed with primary progressive multiple sclerosis according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis.
Requirement for concomitant treatment that could bias the primary evaluation.
Contraindication for MRI.
Contraindications to use MRI Gd contrast-enhancing preparations.
History of infection with the human immunodeficiency virus (HIV).
History of active or latent tuberculosis.
Any other active infections that would adversely affect participation or investigational medicinal product administration in this study, as judged by the Investigator.
Presence of any screening laboratory or electrocardiogram values outside normal limits that were considered in the Investigator's judgment to be clinically significant.
Presence of liver injury.
At screening, the participant was positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or was positive for hepatitis C antibody.
Bleeding disorder or known platelet dysfunction at any time prior to screening visit.
Participant had received any live (attenuated) vaccine (including but not limited to varicella zoster, oral polio, and nasal influenza) within 2 months before first treatment visit.
Participant was receiving strong inducers or inhibitors of cytochrome P450 3A (CYP3A) or CYP2C8 hepatic enzymes.
Participant was receiving anticoagulant/antiplatelet therapies.
Participant had taken other investigational drugs within 3 months or 5 half lives, whichever was longer, before screening visit.
Participant had an Expanded Disability Status Scale score >5.5 at first screening visit.
Participant had a relapse in the 30 days prior to randomization.
Participant was pregnant or a breastfeeding woman.
History or presence of significant other concomitant illness.
The participant had received medications/treatments for multiple sclerosis within a specified time frame.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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There are 47 Locations for this study
Cullman Alabama, 35058, United States
Maitland Florida, 32761, United States
Sunrise Florida, 33351, United States
Tampa Florida, 33612, United States
Savannah Georgia, 31406, United States
Northbrook Illinois, 60062, United States
Dayton Ohio, 45417, United States
Westerville Ohio, 43081, United States
Knoxville Tennessee, 37922, United States
Gatineau , J8Y 1, Canada
Greenfield Park , J4V 2, Canada
Vancouver , V6T 2, Canada
Brno , 62500, Czechia
Hradec Kralove , 50005, Czechia
Jihlava , 58633, Czechia
Ostrava - Poruba , 70852, Czechia
Pardubice , 53203, Czechia
Praha 2 , 12808, Czechia
Praha 5 - Motol , 15006, Czechia
Tallinn , 11315, Estonia
Nancy Cedex , 54035, France
Nantes Cedex 1 , 44093, France
Strasbourg Cedex , 67098, France
Toulouse Cedex 9 , 31059, France
Amsterdam , 1081 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Kazan , 42002, Russian Federation
Moscow , 12536, Russian Federation
Moscow , 12701, Russian Federation
Saint-Petersburg , 19711, Russian Federation
St-Petersburg , 19404, Russian Federation
St-Petersburg , 19702, Russian Federation
Tyumen , 62500, Russian Federation
Bratislava , 82606, Slovakia
Martin , 03659, Slovakia
Barakaldo , 48903, Spain
Barcelona , 08035, Spain
Madrid , 28007, Spain
Murcia , 30120, Spain
Salt , 17190, Spain
Sevilla , 41071, Spain
Chernivtsi , 58018, Ukraine
Dnipro , 49005, Ukraine
Lviv , 79010, Ukraine
Lviv , 79013, Ukraine
Odesa , 65025, Ukraine
Vinnytsya , 21005, Ukraine
Zhytomyr , 10002, Ukraine
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