SAR443820 for Amyotrophic Lateral Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Amyotrophic Lateral Sclerosis+2 More
SAR443820 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, SAR443820, to see if it is safe and effective in treating people with ALS. The trial is divided into two parts: Part A is a 24-week, double-blind, placebo-controlled part, where participants will be given either the drug or a placebo. Part B is an open-label, long-term extension period where all participants will receive the drug.

Eligible Conditions
  • Amyotrophic Lateral Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: From baseline to Week 52, Week 76 and Week 104

Week 8
Assessment of pharmacokinetic parameter -Plasma concentration of SAR443820 -Part A
Week 24
Change from baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ5) -Part A
Change from baseline in serum neurofilament light chain (NfL) -Part A
Change from baseline in slow vital capacity (SVC) -Part A
Change from baseline in the ALSFRS-R total score -Part A
Muscle Strength - Part A
Week 104
Change from baseline in the ALSFRS R total score-Part B
Week 104
Change from baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5)-Part B
Change from baseline in slow vital capacity (SVC)-Part B
Time from baseline to the occurrence of death-Part B
Week 104
Time from baseline to the occurrence of either death, or permanent assisted ventilation (>22 hours daily for >7 consecutive days), whichever comes first - Part B
Up to Week 106
Number of patients with treatment emergent adverse events (TEAE) and Serious adverse event (SAE) -Part B
Up to Week 24
Number of patients with treatmentemergent adverse events (TEAE) and Serious adverse event (SAE) - Part A
Week 24
Combined assessment of the function and survival (CAFS) score -Part A
Week 28
Assessment of pharmacokinetic parameter Plasma concentration of SAR443820 -Part B
Week 52
Change from baseline in serum neurofilament light chain (NfL)-Part B
Combined assessment of the function and survival (CAFS) score -Part B
Week 76, Week 104
Combined assessment of the function and survival (CAFS) score - Part B

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

2 Treatment Groups

SAR443820
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

261 Total Participants · 2 Treatment Groups

Primary Treatment: SAR443820 · Has Placebo Group · Phase 2

SAR443820
Drug
Experimental Group · 1 Intervention: SAR443820 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to week 52, week 76 and week 104

Who is running the clinical trial?

SanofiLead Sponsor
2,032 Previous Clinical Trials
2,956,243 Total Patients Enrolled
2 Trials studying Amyotrophic Lateral Sclerosis
429 Patients Enrolled for Amyotrophic Lateral Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
790 Previous Clinical Trials
1,631,684 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
15 Patients Enrolled for Amyotrophic Lateral Sclerosis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a definite, probable, or possible diagnosis of ALS.
You have had symptoms of ALS for less than two years.
You have a slow vital capacity.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.