Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Terminated · Phase 2 · NCT05237284
Conditions: Amyotrophic Lateral Sclerosis
At a glance
- Research payments reported, 2025
- $154,548
- U.S. investigators named
- 8
- Sites paid
- 8
- Planned or actual enrollment
- 305
About the trial
- Sponsor
- Sanofi
- Tested
- SAR443820 (drug), Placebo (drug)
- Dates
- Started 2022-04-13; completion 2024-03-07
- Results posted
- Yes
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 w…
From ClinicalTrials.gov, last updated 2025-03-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Genzyme Corporation reported $154,548 in research payments for this study in 2025 (11 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Shakti V. Nayar, MD Neurology · Washington, DC
- Nivedita U. Jerath, MD Neurology · Apopka, FL
- Doreen T. Ho, MD Neurology · Burlington, MA
- Nicholas Maragakis, M.D. Neurology · Baltimore, MD
- Hristelina S. Ilieva, M.D. Physical Medicine & Rehabilitation (PM&R) · Philadelphia, PA
- Colin C. Quinn, MD Neurology · Philadelphia, PA
- Mark B. Bromberg, M.D.,PH.D. Neurology · Salt Lake City, UT
- Dominic B. Fee, MD Neurology · Milwaukee, WI
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Johns Hopkins University $36,164
- Hospital of Univ of Pennsylvania, PA $33,696
- University of Utah Hospital and Clinics, UT $33,086
- Jefferson Health Nephrology $15,860
- Adventhealth Orlando, FL $15,337
- Massachusetts General Hospital, MA $9,100
- Georgetown University Office of Tech Commercialization $7,230
- Medical College of Wisconsin Inc Attn Donald Basel $4,075
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.