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A Phase 2, Randomized, Double-blind, Placebo-controlled Parallel Group Study of VHB937 in Amyotrophic Lateral Sclerosis (ALS) Over 40 Weeks Followed by an Open Label Extension (ASTRALS)
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group Phase II study to evaluate the efficacy and safety of VHB937 in participants with early-stage ALS (within 2 years of ALS symptoms onset). The study comprises a core double-blind (DB) 40-week treatment period followed by an open label extension (OLE).
The main questions this trial aims to answer in comparing VHB937 to placebo are: * How long will participants live without needing permanent help from a machine to breathe after starting the trial treatment? * What is the change in the participant's ability to perform daily activities? This will be measured using a questionnaire called the amyotrophic lateral sclerosis functional rating scale-revised (ALSFRS-R). * What adverse events are reported during this trial? An adverse event is any sign or symptom that participants have during a trial. Adverse events may or may not be caused by treatments in the trial. The trial doctors will check participants' ALS and general health throughout the trial.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
University of California San Diego
La Jolla, California, United States
Loma Linda University Health
Loma Linda, California, United States
Keck Medical Center USC
Los Angeles, California, United States
UC San Francisco Medical Center
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
University Of Kansas Medical Center
Kansas City, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
October 17, 2024
Primary Completion Date
September 21, 2026
Completion Date
July 7, 2028
Last Updated
November 12, 2025
251
ACTUAL participants
VHB937
BIOLOGICAL
Placebo
OTHER
Lead Sponsor
Novartis Pharmaceuticals
NCT07187388
NCT07202494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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