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)
Recipient organisationNIHR Sheffield Clinical Research Facility
NIHR supportRecorded as supported by this research centre
PeriodFeb 2025 — Apr 2029
In plain English
AI plain-English summary
A new antibody treatment, VHB937, is being tested in 225 people with ALS across 19 countries to see if it can slow the relentless damage to nerve cells that control movement. ALS destroys the motor neurons that allow the brain to command muscles, leading to progressive weakness, paralysis, and eventually death. Current approved therapies offer only modest benefits. This trial addresses a critical gap: whether activating a specific protein on microglia—the brain’s immune cells—can coax them to protect, rather than attack, neighbouring nerve cells. The core phase is double-blind and runs for 40 weeks, followed by an open-label extension where all participants receive VHB937 for long-term safety monitoring. If VHB937 proves effective, it would offer a fundamentally new way to treat ALS—not by targeting the neurons themselves, but by reprogramming the brain’s own support cells to shield them. That could slow disease progression, extend independence, and buy patients precious months or years. The trial is sponsored by Novartis and funded by the National Institute for Health and Care Research.
View original technical description
The purpose of this trial is to learn about the effects of VHB937 compared with placebo in people with amyotrophic lateral sclerosis (ALS) previously treated with or without an ALS-approved therapy. Amyotrophic lateral sclerosis (ALS) is a nervous system disease that affects the cells in the brain and spinal cord that control muscle movement. This may lead to symptoms like muscle twitching, weakness in an arm or leg, and trouble swallowing. VHB937 is an antibody that works by activating a protein which directs important brain cells, called microglia, to protect nerve cells. This may prevent damage to the nerve cells and could help in the treatment of ALS. This trial has 2 parts: a core part and an open-label extension part. The core part is double-blinded and it contains a screening period and a 40-week treatment part where participants will receive either VHB937 or placebo. Since the core part is double-blind, neither participants nor the study doctor will know which treatment (i.e., VHB937 or placebo) they are assigned to, except in an emergency. Upon completion of the core part, participants who are eligible and willing to continue in the study will receive VHB937 during the open-label extension and will be assessed for long-term safety and efficacy. This open-label extension continues until the last participant stops the VHB937 treatment. About 225 participants are expected to join this trial from 19 countries worldwide. The pharmaceutical company sponsoring this study is Novartis AG Pharma.
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