TerminatedPhase 2

A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis

Stopped: The study was terminated as it did not meet its primary and key secondary endpoints

Belgium, Bulgaria174 participantsStarted 2022-12-19

Plain-language summary

This was 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 was approximately 100 weeks and included 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 study was terminated prior to completion (of Week 96) as primary endpoint was not met. Therefore final duration was less than 96 weeks.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, 18 to 60 years (inclusive) of age, at the time of signing the informed consent. * Participants 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 2 to 6 inclusive at screening. * Participants who were either untreated or in the opinion of the Investigator were 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 was 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 was consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Participants with immunodeficiency syndromes or other autoimmune diseases requiring immunosuppressi…

What they're measuring

Part A: Change From Baseline to Week 48 in Serum Neurofilament Light Chain (sNfL) Levels

Timeframe: Baseline (up to Day 1, pre-dose) and Week 48

Part B: Change From Baseline to Week 72 in Serum Neurofilament Light Chain Levels

Timeframe: Baseline (up to Day 1, pre-dose) and Week 72

Trial details

NCT IDNCT05630547

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-21

Results submitted2025-08-13