ASTRALS
Research type
Research Study
Full title
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)
IRAS ID
1010689
Contact name
Katharina Boehm
Contact email
Sponsor organisation
Novartis Pharma Arzneimittel GmbH
Research summary
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.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0794
Date of REC Opinion
4 Dec 2024
REC opinion
Further Information Favourable Opinion