Multiple sclerosis
Conditions
Interventions
Drug: Frexalimab (SAR441344)
Pharmaceutical form: Solution for infusion, Route of administration: Intravenous (IV) infusion
Drug: Teriflunomide (Aubagio)
Pharmaceutical form: Tablet, Route of admini
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The participant must have been diagnosed with relapsing multiple sclerosis (RMS) according to the 2017 revision of the McDonald diagnostic criteria. - The participant has an expanded disability status scale (EDSS) score =1 documented relapse within the previous year OR >=2 documented relapses within the previous 2 years, OR >=1 documented Gadolinium (Gd) enhancing lesion on a magnetic resonance imaging (MRI) scan within the previous year. - Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion criteria
Exclusion criteria: - The participant has been diagnosed with primary progressive multiple sclerosis (MS) according to the 2017 revision of the McDonald diagnostic criteria. - The participant has a history of infection or may be at risk for infection. - The presence of psychiatric disturbance or substance abuse. - History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment. - Current hypogammaglobulinemia defined by Ig levels below the LLN at Screening or a history of primary hypogammaglobulinemia. - A history or presence of disease that can mimic MS symptoms, such as, but not limited to neuromyelitis optica spectrum disorder, systemic lupus erythematosus, Sjogren's syndrome, acute disseminated encephalomyelitis, and myasthenia gravis. - The participant has had a relapse in the 30 days prior to randomization. - The participant has contraindication for MRI, ie, presence of pacemaker, metallic implants in high risk areas (ie, artificial heart valves, aneurysm/vessel clips), presence of metallic material (eg, shrapnel) in high risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol scheduled MRI scans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses [Time Frame: Until Week 156] ARR during the study period assessed by protocol-defined adjudicated relapses. This endpoint will be analyzed in the intent to treat population of each study using a negative binomial model with the total number of adjudicated relapses per participant occurring during the observation period as the response variable and with terms for treatment group, Gadolinium (Gd)-enhancing T1 lesions at baseline (presence, absence), expanded disability status scale (EDSS) strata (=4), and geographical region (US, non-US). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to onset of composite confirmed disability worsening (cCDW) [Time Frame: Until Week 156] confirmed over 6 months as assessed by the composite of: - increase from the baseline EDSS score of >=1.5 points when the baseline is 0, or >=1.0 point when the baseline is 0.5 to =0.5 point when the baseline is >= 5.5, OR - increase of >=20% from the baseline time in the 9-hole peg test (9HPT), OR - increase of >=20% from the baseline time in the Timed 25-foot walk (T25FW) test 2. Time to onset of cCDW, confirmed over 3 months [Time Frame: Until Week 156] 3. Time to onset of individual components of the composite, confirmed over 3-months or 6-months [Time Frame: Until Week 156] 4. Time to onset of confirmed disability improvement [Time Frame: Until Week 156] defined as decrease from baseline EDSS score of >=1.0 or >=0.5 points when the baseline is >=2 to 5.5 points, respectively, confirmed over 6 months. No improvement possible for 0 to 1.5 points 5. Progression independent of relapse activity defined as the time to onset of 6-month cCDW [Time Frame: Until Week 156] defined by either no prior relapse or an onset more than 90 days after the start date of the last adjudicated relapse 6. Total number of new and/or enlarging T2-hyperintense lesions as detected by MRI [Time Frame: Until Week 156] defined as the sum of the individual number of new and/or enlarging T2 lesions at all scheduled visits starting after baseline up to and including the end of study (EOS) visit 7. Total number of new Gd-enhancing T1-hyperintense lesions per scan as detected by MRI [Time Frame: Until Week 156] defined as the sum of the individual number of new Gd enhancing T1-hyperintense lesions at all scheduled visits starting after baseline up to and including the EOS visit divided by the number of scans 8. Percent change in brain volume loss as detected by brain MRI scans at the EOS compared to Month 6 [Time Frame: From Week 24 to Week 156] 9. Change in cognitive function at the EOS compared to ba | — |
Countries
11 other countries, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed