Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Public ClinicalTrials.gov record NCT05237284. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SAR443820 in Adult Participants With Amyotrophic Lateral Sclerosis, Followed by an Open-label Extension
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a parallel treatment, Phase 2, randomized, double-blind study to assess the efficacy, safety, tolerability, PK, and PD of twice daily (BID) oral SAR443820 compared with placebo in male and female participants, 18 to 80 years of age with ALS followed by an open-label, long-term extension period. Study ACT16970 consisted of 2 parts (A and B) as follows: Part A was a 24-week, double blind, placebo-controlled part, preceded by a screening period of up to 4 weeks before Day 1. On Day 1 of Part A, participants were randomized in a 2:1 ratio to the SAR443820 treatment arm or matching placebo arm as listed below: * Treatment arm: SAR443820, BID * Placebo arm: Placebo, BID Randomization was stratified by the geographic region of the study site, region of ALS onset (bulbar vs other areas), use of riluzole (yes vs no), use of edaravone (yes vs no) and use of the combination of sodium phenylbutyrate and taurursodiol (named Relyvrio in the United States of America \[USA\] and Albrioza in Canada) (yes vs no). Participants attended in-clinic study assessments at baseline (Day 1), Week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Week 16, Week 20, Week 21, Week 22, Week 23, and Week 24. All ongoing participants at Week 24 rolled to open-label extension Part B. The Week 24 Visit was the end of Part A and the beginning of Part B. Part B was an open-label, long-term extension period that starts from Week 24 and continues up to Week 106. The objectives of Part B were to provide extended access to SAR443820 participants in Part A and to further evaluate the safety and efficacy of long-term SAR443820 treatment. The treatment assignment of participants at randomization in Part A remained blinded to Investigators, participants, and site personnel until the end of Part B. Every participant, except those who discontinued Investigational Medicinal Product (IMP) treatment permanently in Part A, received BID oral tablets of SAR443820 in Part B.
Study identification
- NCT ID
- NCT05237284
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 305 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 13, 2022 (Actual)
- Primary completion
- Mar 7, 2024 (Actual)
- Completion
- Mar 7, 2024 (Actual)
- Last update posted
- Mar 21, 2025
2022 – 2024
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UC San Diego Health Site Number : 8400022 | La Jolla | California | 92121 | — |
| USC Site Number : 8400008 | Los Angeles | California | 90033 | — |
| University of California Irvine Site Number : 8400012 | Orange | California | 92868 | — |
| California Pacific Medical Center Site Number : 8400015 | San Francisco | California | 94115 | — |
| University of Colorado Site Number : 8400025 | Aurora | Colorado | 80045 | — |
| Georgetown University Medical Center Site Number : 8400020 | Washington D.C. | District of Columbia | 20007 | — |
| Mayo Clinic Site Number : 8400029 | Jacksonville | Florida | 32224 | — |
| AdventHealth Medical Group - Neurology at Winter Park Site Number : 8400006 | Winter Park | Florida | 32789 | — |
| Northwestern Medical Group, Department of Neurology Site Number : 8400003 | Chicago | Illinois | 60611 | — |
| Johns Hopkins University Site Number : 8400028 | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital Site Number : 8400001 | Boston | Massachusetts | 02114 | — |
| Mount Sinai - Union Square Site Number : 8400002 | New York | New York | 10003 | — |
| Penn State Milton S. Hershey Medical Center Site Number : 8400004 | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania Site Number : 8400021 | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University Hospital Site Number : 8400014 | Philadelphia | Pennsylvania | 19107 | — |
| University of Utah Site Number : 8400009 | Salt Lake City | Utah | 84132 | — |
| Froedtert Hospital & Medical College of Wisconsin Site Number : 8400010 | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 46 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05237284, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 21, 2025 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05237284 live on ClinicalTrials.gov.