SAR443820 for ALS
(HIMALAYA Trial)
Trial Summary
What is the purpose of this trial?
This trial tests SAR443820, a pill taken regularly, in adults aged 18-80 with ALS. It aims to see if the new medication helps ALS patients and is safe over time.
Will I have to stop taking my current medications?
The trial does not require you to stop taking your current medications if you are on riluzole, edaravone, or the combination of sodium phenylbutyrate and taurursodiol, as long as you are on a stable dose or approved schedule. However, you cannot be on strong or moderate CYP3A4 inhibitors or inducers before joining the trial.
What data supports the effectiveness of the drug SAR443820 for ALS?
Research Team
Clinical Sciences & Operations
Principal Investigator
Sanofi
Eligibility Criteria
Adults aged 18-80 with ALS, able to swallow tablets, and not severely ill from other conditions can join. They must have had symptoms for less than 2 years and a breathing capacity over 60% of expected. If taking riluzole, edaravone or sodium phenylbutyrate/taurursodiol (Relyvrio/Albrioza), doses must be stable for at least 4 weeks.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Part A)
Participants receive either SAR443820 or placebo in a double-blind manner
Open-label Extension (Part B)
Participants receive SAR443820 in an open-label manner to evaluate long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Not Applicable
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University