Multiple sclerosis
Conditions
Interventions
Drug: Frexalimab (SAR441344)
Pharmaceutical form: Solution for infusion, Route of administration: Intravenous (IV) infusion
Drug: Placebo
Pharmaceutical form: Solution for infusion, Route of adminis
Sponsors
Obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Participant must have a previous diagnosis of relapsing remitting multiple sclerosis (RRMS) in accordance with the 2017 revised McDonald criteria. - Participant must have a current diagnosis of secondary progressive multiple sclerosis (SPMS) in accordance with the clinical course criteria revised in 2013 endorsed by an Adjudication Committee. - Participant must have documented evidence of disability progression observed during the 12 months before screening. Eligibility will be analyzed by an Adjudication Committee. - Absence of clinical relapses for at least 24 months. - The participant must have an expanded disability status scale (EDSS) score at screening from 3.0 to 6.5 points, inclusive. - Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - For patients eligible to be treated with siponimod: 1) does not tolerate it due to side effects or safety reasons, or 2) has failed siponimod treatment due to perceived lack of efficacy, or 3) has declined siponimod treatment.
Exclusion criteria
Exclusion 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 immunoglobulin levels (IgG and/or IgM) below the lower limits of normal (LLN) at Screening or a history of primary hypogammaglobulinemia. Patients with a history of secondary hypogammaglobulinemia induced by anti-C20 monoclonal antibodies (mAb) (eg, ocrelizumab, ofatumumab, ublituximab, rituximab) may be considered for study inclusion provided their immunoglobulin levels are within the normal limits (WNL) at time of Screening. - A history or presence of disease that can mimic multiple sclerosis (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 sensitivity to any of the study interventions, or components thereof, or has a drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. - The participant was previously exposed to frexalimab. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time to onset of composite confirmed disability progression (cCDP) confirmed over 6 months in the double-blind treatment period [Time Frame: Up to 36 months] Defined as Increase from the baseline expanded disability status scale (EDSS) score of >=1.0 point when the baseline is =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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Time to onset of composite cCDP confirmed over 3 months in the double-blind treatment period [Time Frame: Up to 36 months ] 2.Time to onset of CDP individual components of the composite, confirmed over 3-months or 6-months in the double-blind treatment period [Time Frame: Up to 36 months ] increase from the baseline EDSS score of >=1.0 point when the baseline is =0.5 point when the baseline is >=5.5 3.Time to onset of confirmed disability improvement (CDI) in the double-blind treatment period [Time Frame: Up to 36 months ] defined as decrease from the baseline EDSS score of >=1.0 or >= 0.5 points when baseline is 5.5 points, respectively, confirmed over 6 months. 4. Number of new and/or enlarging T2-hyperintense lesions per scan as detected by MRI [Time Frame: Up to 36 months] defined as the sum of the individual number of new and/or enlarging T2-hyperintense lesions at all scheduled visits starting after baseline up to the end of double-blind treatment period 5. Percent change in brain volume loss as detected by MRI scans at the end of double-blind treatment period compared to Month 6 [Time Frame: Up to 36 months] 6. Change in cognitive function at the end of double-blind treatment period compared to baseline as assessed by symbol digit modalities test (SDMT) [Time Frame: Baseline, Up to 36 month] 7. Change from baseline in multiple sclerosis impact scale 29 version 2 (MSIS-29v2) questionnaire scores over time in the double-blind treatment period [Time Frame: Baseline, Up to 36 months] 8. Change from baseline in patient reported outcome measurement information system Fatigue multiple sclerosis (MS)-8a over time in the double-blind treatment period [Time Frame: Baseline, Up to 36 months] 9. Annualized relapse rate during the double-blind treatment period assessed by protocol defined adjudicated relapses [Time Frame: Up to 36 months] 10. Adverse events (AEs), serious adverse events (SAEs), AEs leading to permanent study intervention discontinuation, AEs of specia | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Poland, Portugal, Saudi Arabia, South Korea, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed