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SAR443820 for ALS (HIMALAYA Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Either not currently receiving the combination of sodium phenylbutyrate and taurursodiol or on the approved standard schedule of the combination of sodium phenylbutyrate and taurursodiol treatment for at least 4 weeks before the screening visit. Participants receiving the combination of sodium phenylbutyrate and taurursodiol are expected to remain on the approved standard schedule throughout the duration of the study
Participants with a body weight no less than 45 kg and body mass index no less than 18 kg/m2 at the screening visit
Must not have
Participants who have received stem cell or gene therapy for ALS at any time in the past
History of recent serious infection (eg, pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with IV antibiotics, antivirals, or antifungals within 4 weeks of screening; or chronic bacterial infection (such as tuberculosis) deemed unacceptable as per the Investigator's judgment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 52, week 76 and week 104
Awards & highlights

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.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Specific side effects of SAR443820 aren't listed but may include typical drug reactions like nausea, headaches, allergic responses or potential interactions with existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not on sodium phenylbutyrate and taurursodiol, or have been on it for 4 weeks.
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I weigh at least 45 kg and my BMI is at least 18.
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I have been diagnosed with ALS.
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I can swallow pills.
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My first ALS symptoms appeared less than 2 years ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had stem cell or gene therapy for ALS.
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I haven't had a serious infection or been hospitalized for one in the last month.
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I don't have severe health issues other than ALS that would make it unsafe for me to join this study.
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I have not received a live vaccine in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 52, week 76 and week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 52, week 76 and week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the ALSFRS-R total score -Part A
Combined assessment of the function and survival (CAFS) score -Part B
Secondary outcome measures
Assessment of pharmacokinetic parameter -Plasma concentration of SAR443820 -Part A
Assessment of pharmacokinetic parameter Plasma concentration of SAR443820 -Part B
Change from baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5)-Part B
+13 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR443820
2022
Completed Phase 1
~120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Amyotrophic Lateral Sclerosis (ALS) include riluzole, edaravone, and sodium phenylbutyrate-taurursodiol (PB-TURSO). Riluzole inhibits glutamate release, reducing excitotoxicity that damages neurons. Edaravone acts as a free radical scavenger, mitigating oxidative stress implicated in neuronal damage. PB-TURSO combines sodium phenylbutyrate, which reduces endoplasmic reticulum stress, and taurursodiol, which stabilizes mitochondrial function. These treatments are important for ALS patients as they target different pathways involved in neuronal degeneration, potentially slowing disease progression and improving quality of life.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,173 Previous Clinical Trials
3,516,185 Total Patients Enrolled
5 Trials studying Amyotrophic Lateral Sclerosis
547 Patients Enrolled for Amyotrophic Lateral Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
866 Previous Clinical Trials
2,019,904 Total Patients Enrolled
4 Trials studying Amyotrophic Lateral Sclerosis
133 Patients Enrolled for Amyotrophic Lateral Sclerosis

Media Library

SAR443820 Clinical Trial Eligibility Overview. Trial Name: NCT05237284 — Phase 2
Amyotrophic Lateral Sclerosis Research Study Groups: Placebo, SAR443820
Amyotrophic Lateral Sclerosis Clinical Trial 2023: SAR443820 Highlights & Side Effects. Trial Name: NCT05237284 — Phase 2
SAR443820 2023 Treatment Timeline for Medical Study. Trial Name: NCT05237284 — Phase 2
Amyotrophic Lateral Sclerosis Patient Testimony for trial: Trial Name: NCT05237284 — Phase 2
~94 spots leftby Jul 2025