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)
Status: Recruiting
Location: See all (90) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• are 18 years of age or older
• male or female, if of childbearing potential, strict contraception required
• have ALS confirmed by the trial doctors using different tests.
• have mild symptoms of ALS as measured by the ALSFRS-R questionnaire (total score \>=30).
• have had symptoms of ALS (weakness) within 24 months of taking part in this trial.
• have not received treatment for ALS or are currently on a stable dose of an approved treatment for ALS.
• have the ability to slowly exhale a volume of air at least 60% of what is expected for the participant's sex, height and age.
Locations
United States
California
University of California San Diego
ACTIVE_NOT_RECRUITING
La Jolla
Keck Medical Center USC
ACTIVE_NOT_RECRUITING
Los Angeles
UC San Francisco Medical Center
ACTIVE_NOT_RECRUITING
San Francisco
Florida
University of Miami
ACTIVE_NOT_RECRUITING
Miami
Orlando Health Clinical Trials
ACTIVE_NOT_RECRUITING
Orlando
Georgia
Emory University School of Medicine
ACTIVE_NOT_RECRUITING
Atlanta
Kansas
University Of Kansas Medical Center
ACTIVE_NOT_RECRUITING
Kansas City
Massachusetts
Massachusetts General Hospital
ACTIVE_NOT_RECRUITING
Boston
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
North Carolina
Duke University Health System
ACTIVE_NOT_RECRUITING
Durham
Nebraska
Neurology Associates P C
RECRUITING
Lincoln
University of Nebraska Medical Center
ACTIVE_NOT_RECRUITING
Omaha
New York
Lange Neurology PC
ACTIVE_NOT_RECRUITING
New York
University of Rochester Medical Center
ACTIVE_NOT_RECRUITING
Rochester
Ohio
Univ of Cincinnati Medical Center
ACTIVE_NOT_RECRUITING
Cincinnati
The Ohio State University
RECRUITING
Columbus
Oregon
Providence ALS Center
RECRUITING
Portland
Pennsylvania
Temple University
ACTIVE_NOT_RECRUITING
Philadelphia
Tennessee
AMR Knoxville
ACTIVE_NOT_RECRUITING
Knoxville
Texas
Austin Neuromuscular Center
ACTIVE_NOT_RECRUITING
Austin
Nerve and Muscle Center of Texas
ACTIVE_NOT_RECRUITING
Houston
Washington
University of Washington Medical Center
ACTIVE_NOT_RECRUITING
Seattle
Other Locations
Australia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Cauldfield
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Herston
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
North Ryde
Novartis Investigative Site
RECRUITING
Randwick
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Southport
Belgium
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Leuven
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Liège
Canada
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Calgary
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hamilton
Novartis Investigative Site
RECRUITING
Montreal
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Montreal
China
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Beijing
Denmark
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Aalborg
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Kobenhavn N V
Finland
Novartis Investigative Site
RECRUITING
Turku
France
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bron
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lille
Novartis Investigative Site
RECRUITING
Limoges
Novartis Investigative Site
RECRUITING
Montpellier
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Nice
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Paris
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Tours
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Berlin
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Hanover
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Lübeck
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Mannheim
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Munich
Novartis Investigative Site
RECRUITING
Münster
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Rostock
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ulm
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Würzburg
Ireland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Dublin
Italy
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Baggiovara
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Milan
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Pisa
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Torino
Japan
Novartis Investigative Site
RECRUITING
Nagoya
Novartis Investigative Site
RECRUITING
Ohtsu
Novartis Investigative Site
RECRUITING
Ōta-ku
Novartis Investigative Site
RECRUITING
Sendai
Novartis Investigative Site
RECRUITING
Tokushima
Netherlands
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Utrecht
Poland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Bydgoszcz
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Krakow
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Krakow
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Warsaw
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Warsaw
Republic of Korea
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Seoul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Seoul
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Yangsan
Spain
Novartis Investigative Site
RECRUITING
Barcelona
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Barcelona
Novartis Investigative Site
RECRUITING
Donostia / San Sebastian
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Novartis Investigative Site
RECRUITING
Madrid
Novartis Investigative Site
RECRUITING
Málaga
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Santiago
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Valencia
Sweden
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Malmo
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Stockholm
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Umeå
Switzerland
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Basel
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sankt Gallen
United Kingdom
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Farnborough
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
London
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
London
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Sheffield
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Stoke-on-trent
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2024-10-17
Estimated Completion Date: 2028-06-20
Participants
Target number of participants: 225
Treatments
Experimental: Arm 1
I.V. infusions
Placebo_comparator: Arm 2
I.V. infusions
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals