Sanofi is recruiting patients for the clinical trial of A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis.
This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)
The indicative completion of the clinical trial will be expected in August, 2025. The study will take place at the Investigational Site Number: 3800001, Pozzilli, Isernia, Italy.
Enrolled will be the adult patients up to 60 years (inclusive) of age, with diagnosis of RRMS, SPMS (relapsing or non-relapsing) or primary progressive subtype according to the 2017 revision of the McDonald diagnostic criteria (SPMS diagnostic criteria according to initial relapsing remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus; progression denotes the continuous worsening of neurological impairment over at least 6 months). Participants with Expanded Disability Status Scale (EDSS) score of 26 inclusive at screening. Participants who are either untreated or in the opinion of the Investigator are stable on an allowed disease-modifying therapy (DMT) (interferons, glatiramer acetate, fumarates, or teriflunomide) for at least the past 3 months, AND not anticipated to require a change in multiple sclerosis (MS) treatment for the duration of Part A and Part B (through Week 96); in Part B changes in dose of allowed DMTs or transition to other allowed DMTs is permitted). Participants with body weight at least 45 kg and body mass index (BMI) at least 18.0 kg/m^2. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
The exclusion criteria and the contact details may be found here: https://ichgcp.net/clinical-trials-registry/NCT05630547.