Multiple sclerosis MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Sanofi-Aventis Recherche et Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I 01. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. I 02. 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. I 03. 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. I 04. 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. I 05. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. I 06. Capable of giving signed informed consent. 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: E 01. The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS. E 02. The participant has conditions or situations that would adversely affect participation in this study. E 03. The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study. E 04. 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. E 05. Allergies to humanized monoclonal antibodies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule. E 06. The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment. E 07. The participant has taken other investigational drug within 3 months or 5-halflive, whichever is longer, before the screening visit. E 08. The participant has an EDSS score >5.5 at the first screening visit. E 09. The participant has had a relapse in the 30 days prior to randomization. E 10. Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission. E 11. Abnormal laboratory test(s) at Screening. E 12. Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (antiHBc Ab) at screening or within 3 months prior to first dose of study intervention. E 13. Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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;Primary end point(s): Number of new Gadolinium (Gd)-enhancing T1hyperintense (GdE T1) lesions : measured by brain magnetic resonance imaging (MRI);Timepoint(s) of evaluation of this end point: At Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1/ Number of new or enlarging T2 lesions: measured by brain magnetic resonance imaging (MRI) 2/ Total number of GdE T1 lesions: Total number of GdE T1 lesions at Week 12 3/ Adverse events (AEs) and serious adverse events (SAEs): Number of participants with AEs and SAEs 4/Antidrug antibodies (ADA): Number of participants with ADA 5/ Pharmacokinetic (PK) parameters: Cmax: maximum concentration 6/ PK parameter: tmax: time to Cmax 7/ PK parameter: AUC0-tau: area under the curve over the dosing interval 8/ PK parameter: t1/2z: elimination halflife ;Timepoint(s) of evaluation of this end point: 1/ and 2/: at Week 12 3/ to 8/: Until Week 88 | — |
Countries
Bulgaria, Canada, Czechia, Czech Republic, France, Germany, Russian Federation, Spain, Turkey, United States
Outcome results
None listed