A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT06643481
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
251 participants
INTERVENTIONAL
2024-10-17
2028-07-07
Brief Summary
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Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1
I.V. infusions
VHB937
VHB937 solution for infusion
Arm 2
I.V. infusions
Placebo
Solution for infusion
Interventions
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VHB937
VHB937 solution for infusion
Placebo
Solution for infusion
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 24 weeks after stopping study medication.
* History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study.
* Clinical evidence of liver or renal disease/injury.
* Laboratory evidence of hematological abnormalities
* Presence of unstable psychiatric disease, cognitive impairment, neurological disease other than ALS, dementia or substance abuse that would impair ability of the participant to provide informed consent, in the investigator's opinion.
* Participants that reported 'yes' on any suicidal ideation section except for the "Non-Suicidal Self-Injurious Behavior" in the past 2 years as per C-SSRS.
* Presence of cancer, HIV, Hep B, Hep C, tuberculosis, uncontrolled diabetes
* History of active severe respiratory disease, including Chronic Obstructive Pulmonary Disease, interstitial lung disease or pulmonary fibrosis.
* Taking any prohibited medications
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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Randwick, New South Wales, Australia
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Herston, Queensland, Australia
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Cauldfield, Victoria, Australia
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Southport, , Australia
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Leuven, , Belgium
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Liège, , Belgium
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Calgary, Alberta, Canada
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Hamilton, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Beijing, , China
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Aalborg, , Denmark
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Kobenhavn N V, , Denmark
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Turku, , Finland
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Limoges, Haute Vienne, France
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Bron, , France
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Lille, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Tours, , France
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Mannheim, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Berlin, , Germany
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Hanover, , Germany
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Lübeck, , Germany
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Münster, , Germany
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Ulm, , Germany
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Dublin, , Ireland
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Milan, MI, Italy
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Modena, MO, Italy
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Pisa, PI, Italy
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Torino, TO, Italy
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Nagoya, Aichi-ken, Japan
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Sendai, Miyagi, Japan
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Ohtsu, Shiga, Japan
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Tokushima, Tokushima, Japan
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Ōta-ku, Tokyo, Japan
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Utrecht, , Netherlands
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Krakow, Poland, Poland
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Bydgoszcz, , Poland
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Krakow, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Yangsan, Gyeongsangnam-do, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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L'Hospitalet de Llobregat, Barcelona, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Santiago, Corunja, Spain
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Madrid, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Malmo, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Basel, , Switzerland
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Sankt Gallen, , Switzerland
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Sheffield, South Yorkshire, United Kingdom
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Farnborough, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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2024-512536-29-00
Identifier Type: OTHER
Identifier Source: secondary_id
CVHB937B12201
Identifier Type: -
Identifier Source: org_study_id