NCT05630547

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

A Phase 2 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effect of SAR443820 on Serum Neurofilament Levels in Participants With Multiple Sclerosis, Followed by an Open-label Long-term Extension Period

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 100 weeks

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	SAR443820	Tablet by oral administration
OTHER	Placebo	Tablet by oral administration

Timeline

• Start date: 2022-12-19
• Primary completion: 2024-11-21
• Completion: 2024-11-21
• First posted: 2022-11-29
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

35 sites across 10 countries: Belgium, Bulgaria, Canada, Chile, China, France, Germany, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study