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A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Novartis Pharmaceuticals
Summary
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).
Official 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)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
251
Start Date
2024-10-17
Completion Date
2028-07-07
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
VHB937
VHB937 solution for infusion
Placebo
Solution for infusion
Locations (86)
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
Neurology Associates P C
Lincoln, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Lange Neurology PC
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University Health System
Durham, North Carolina, United States
Univ of Cincinnati Medical Center
Cincinnati, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Providence ALS Center
Portland, Oregon, United States
Temple University
Philadelphia, Pennsylvania, United States
AMR Knoxville
Knoxville, Tennessee, United States
Austin Neuromuscular Center
Austin, Texas, United States
Nerve and Muscle Center of Texas
Houston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
Novartis Investigative Site
North Ryde, New South Wales, Australia
Novartis Investigative Site
Randwick, New South Wales, Australia
Novartis Investigative Site
Herston, Queensland, Australia
Novartis Investigative Site
Caulfield South, Victoria, Australia
Novartis Investigative Site
Southport, Australia
Novartis Investigative Site
Leuven, Vlaams Brabant, Belgium
Novartis Investigative Site
Liège, Belgium
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Aalborg, Denmark
Novartis Investigative Site
Kobenhavn N V, Denmark
Novartis Investigative Site
Limoges, Haute Vienne, France
Novartis Investigative Site
Bron, France
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Tours, France
Novartis Investigative Site
Mannheim, Baden-Wurttemberg, Germany
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Würzburg, Bavaria, Germany
Novartis Investigative Site
Rostock, Mecklenburg-Vorpommern, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Hanover, Germany
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Lübeck, Germany
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Münster, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Dublin, Ireland
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Modena, MO, Italy
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Pisa, PI, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Utrecht, Netherlands
Novartis Investigative Site
Bydgoszcz, Poland
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Krakow, Poland
Novartis Investigative Site
Krakow, Poland
Novartis Investigative Site
Warsaw, Poland
Novartis Investigative Site
Warsaw, Poland
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
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Donostia / San Sebastian, Gipuzkoa, Spain
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Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Málaga, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative Site
Malmo, Sweden
Novartis Investigative Site
Stockholm, Sweden
Novartis Investigative Site
Umeå, Sweden
Novartis Investigative Site
Basel, Switzerland
Novartis Investigative Site
Sankt Gallen, Switzerland
Novartis Investigative Site
Sheffield, South Yorkshire, United Kingdom
Novartis Investigative Site
Farnborough, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Stoke-on-Trent, United Kingdom