SAR443820 for ALS

(HIMALAYA Trial)

Recruiting at 130 trial locations

Overseen By Trial 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

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.

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

Treatment Details

Interventions

• Not Applicable (Other)

Trial Overview The 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

Group I: SAR443820 Experimental Treatment 1 Intervention

twice daily (BID) oral SAR443820

Group II: Placebo Placebo Group 1 Intervention

twice daily (BID) oral placebo

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