SAR443820 for ALS
(HIMALAYA Trial)
Recruiting at 130 trial locations
TT
Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Sanofi
Prior Safety Data
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.
Research Team
CS
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
I am either not on edaravone or following its standard treatment schedule.
I am not on sodium phenylbutyrate and taurursodiol, or have been on it for 4 weeks.
I am not on riluzole, or I have been on a stable dose for at least 4 weeks.
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Exclusion Criteria
Having central IV lines, such as a peripherally inserted central catheter (PICC), midline, or portacath lines
Bilirubin >1.5 × ULN unless the participant has documented Gilbert syndrome (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%)
Serum albumin <3.5 g/dL
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Treatment Details
Interventions
- Not Applicable (Other)
Trial OverviewThe trial is testing SAR443820's effectiveness in slowing down ALS progression compared to a placebo. Participants are randomly assigned to either the drug or placebo group and will switch to open-label SAR443820 after the initial double-blind phase.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR443820Experimental Treatment1 Intervention
twice daily (BID) oral SAR443820
Group II: PlaceboPlacebo Group1 Intervention
twice daily (BID) oral placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Trials
2,246
Recruited
4,085,000+
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