Relapsing Multiple Sclerosis MedDRA version: 20.0 Level: PT Classification code 10067063 Term: Progressive relapsing multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Genzyme Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent. - Participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria. - Participant must have at least 1 documented relapse within the previous year, =2 documented relapses within the previous 2 years, or =1 active Gadolinium (Gd)-enhancing brain lesion on an magnetic resonance imaging (MRI) scan in the past 6 months and prior to screening. - A female participant must use a double contraception method including a highly effective method of birth control, except if she has undergone sterilization at least 3 months earlier or is postmenopausal. - Male participants, whose partners are of childbearing potential (including breastfeeding women), must accept 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 are pregnant must use, during sexual intercourse, a condom from inclusion up to 3 months after the last dose. - Male participants must have agreed not to donate sperm from the inclusion up to 3 months after the last dose. - Participant must have given written informed consent prior to undertaking any study-related procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - The participant has been diagnosed with primary progressive multiple sclerosis (PPMS) according to the 2017 revision of the McDonald diagnostic criteria or with non relapsing secondary progressive multiple sclerosis (SPMS). - 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 (IMP) administration in this study, as judged by the Investigator. - Presence of any screening laboratory or ECG values outside normal limits that are considered in the Investigator’s judgment to be clinically significant. - Presence of liver injury. - At screening, the participant is positive for hepatitis B surface antigen and/or hepatitis B core antibody and/or is positive for hepatitis C antibody. - Bleeding disorder or known platelet dysfunction at any time prior to screening visit. - Participant has 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 is receiving strong inducers or inhibitors of CYP3A or CYP2C8 hepatic enzymes. - Participant is receiving anticoagulant/antiplatelet therapies. - Participant has taken other investigational drugs within 3 months or 5 half lives, whichever is longer, before screening visit. - Participant has an Expanded Disability Status Scale (EDSS) score >5.5 at screening visit. - Participant has had a relapse in the 30 days prior to randomization. - Participant is pregnant or a breastfeeding woman. - History or presence of significant other concomitant illness. - The participant has received medications/treatments for MS within a specified time frame.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions; Secondary Objective: - To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging measures - To evaluate the safety and tolerability of SAR442168 ;Primary end point(s): Number of new Gd-enhancing T1 hyperintense lesions : Number of new Gd-enhancing T1 hyperintense lesions at the end of 12 weeks of SAR442168 treatment as detected by brain MRI;Timepoint(s) of evaluation of this end point: Week 12 for Arms 1-4, Week 4 and Week 16 for Arms 5-8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - Number of new or enlarging T2 lesions : Number of new or enlarging T2 lesions at the end of 12 weeks of SAR442168 treatment 2 - Total number of Gd-enhancing T1 hyperintense lesions : Total number of Gd-enhancing T1-hyperintense lesions at the end of 12 weeks of SAR442168 treatment 3 - Adverse events : Number (n) and percentage (%) of participants experiencing an adverse event (AE)/Serious Adverse Event (SAE) or potentially clinically significant abnormalities in laboratory tests, electrocardiogram (ECG), or vital signs ; Timepoint(s) of evaluation of this end point: 1, 2 : Week 12 for Arms 1-4, Week 4 and Week 16 for Arms 5-8 3 : From baseline to the end of study (approximately 20 weeks) | — |
Countries
Canada, Czech Republic, Estonia, France, Netherlands, Norway, Russian Federation, Slovakia, Spain, Sweden, Ukraine, United States
Contacts
Public Contactwww.sanofi.cz
sanofi-aventis, s.r.o.
Outcome results
None listed