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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 52, week 76 and week 104
Awards & highlights

HIMALAYA Trial 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.

HIMALAYA Trial 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.
Select...
I have been diagnosed with ALS.
Select...
I can swallow pills.
Select...
My first ALS symptoms appeared less than 2 years ago.

HIMALAYA Trial 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

HIMALAYA 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

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,175 Total Patients Enrolled
5 Trials studying Amyotrophic Lateral Sclerosis
547 Patients Enrolled for Amyotrophic Lateral Sclerosis
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,994 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any US-based medical facilities conducting this research endeavor?

"AdventHealth Medical Group - Neurology at Winter Park-Site Number:8400006 in Winter Park, University of Pennsylvania-Site Number:8400021 in Philadelphia and Investigational Site Number :1240008 Toronto are three locations that are currently recruiting participants for this trial. Additionally, there a dozen more sites accepting patients across the globe."

Answered by AI

Is there an age restriction for participating in this experiment?

"This trial only allows enrolment of participants aged between 18 and 80. For minors, there are 44 trials available; for elderly individuals over 65 years old, 394 options exist."

Answered by AI

Am I qualified to partake in this research endeavor?

"The current trial is enrolling 261 participants between 18 and 80 years of age, diagnosed with amyotrophic lateral sclerosis. In addition to this, the individuals must meet certain additional conditions: male or female sex; two year onset since initial symptoms; slow vital capacity above 60% predicted value; able to swallow tablets at screening visit period; either not on riluzole treatment or have been on a stable dose for four weeks prior to enrollment date; either not receiving edaravone therapy or having completed one cycle before screening visit while continuing use throughout duration of study; minimum body weight 45 kgs and BMI no less than 18 kg/"

Answered by AI

How extensive is the cohort for this clinical investigation?

"As indicated by the inclusion criteria, this trial requires 261 qualified participants. Those interested can enrol at AdventHealth Medical Group - Neurology at Winter Park-Site Number:8400006 in Winter Park, Pennsylvania or University of Pennsylvania-Site Number:8400021 in Philadelphia, Ontario."

Answered by AI

Has SAR443820 been authorized by the FDA yet?

"SAR443820's safety has been partially demonstrated in prior trials, so it earned a score of 2. As this is still an early phase trial, there is no evidence yet to back up claims on the drug's efficacy."

Answered by AI

Are there any open enrollment opportunities for this trial presently?

"Per the information found on clinicaltrials.gov, this research is recruiting participants as of October 26th 2022; it was initially posted to the website on April 13th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
USC-Site Number:8400008
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have bulbar palsy and C9 mutation. Complete phase 2 ton-101 trial at uc Irvine where I’m treated. Their not accepting new patients for SAR443820 trial.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)
2022. "Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05237284.
~102 spots leftby Apr 2025
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