A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)

Last updated: June 25, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

2

Condition

Amyotrophic Lateral Sclerosis (Als)

Scar Tissue

Neurologic Disorders

Treatment

VHB937

VHB837

Placebo

Clinical Study ID

NCT06643481
CVHB937B12201
2024-512536-29-00
  • Ages 18-100
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 approvedtreatment for ALS.

  • have the ability to slowly exhale a volume of air at least 60% of what is expectedfor the participant's sex, height and age.

Exclusion

Exclusion Criteria:

  • Use of other investigational drugs within 5 half-lives of screening, or within 30days (e.g., small molecules) / or until the expected pharmacodynamic effect hasreturned to baseline (e.g., biologics), whichever is longer; or longer if requiredby local regulations.

  • Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionwhile taking study treatment and for 24 weeks after stopping study medication.

  • History or current diagnosis of cardiac conditions or ECG abnormalities indicatingsignificant 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 diseaseother than ALS, dementia or substance abuse that would impair ability of theparticipant 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 ObstructivePulmonary Disease, interstitial lung disease or pulmonary fibrosis.

  • Taking any prohibited medications

Study Design

Total Participants: 251
Treatment Group(s): 3
Primary Treatment: VHB937
Phase: 2
Study Start date:
October 17, 2024
Estimated Completion Date:
July 10, 2028

Study Description

The main questions this trial aims to answer in comparing VHB937 to placebo are:

  • 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.

Connect with a study center

  • Novartis Investigative Site

    North Ryde, New South Wales 2109
    Australia

    Site Not Available

  • Novartis Investigative Site

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Novartis Investigative Site

    Cauldfield, Victoria 3162
    Australia

    Active - Recruiting

  • Novartis Investigative Site

    Caulfield South, Victoria 3162
    Australia

    Site Not Available

  • Novartis Investigative Site

    Southport, 4215
    Australia

    Site Not Available

  • Novartis Investigative Site

    Leuven, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liège, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Calgary, Alberta T2N 4N1
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal, Quebec H4A 3T2
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal 6077243, Quebec 6115047 H2X 0A9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100191
    China

    Site Not Available

  • Novartis Investigative Site

    Aalborg, 9000
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Kobenhavn N V, 2400
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Bron, 69677
    France

    Site Not Available

  • Novartis Investigative Site

    Lille, 59037
    France

    Site Not Available

  • Novartis Investigative Site

    Nice, 06001
    France

    Site Not Available

  • Novartis Investigative Site

    Paris, 75013
    France

    Site Not Available

  • Novartis Investigative Site

    Tours, 37044
    France

    Site Not Available

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg 68167
    Germany

    Site Not Available

  • Novartis Investigative Site

    Munich, Bavaria 81675
    Germany

    Site Not Available

  • Novartis Investigative Site

    Würzburg, Bavaria 97080
    Germany

    Site Not Available

  • Novartis Investigative Site

    Rostock, Mecklenburg-Vorpommern 18057
    Germany

    Site Not Available

  • Novartis Investigative Site

    Berlin, 13353
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hanover, 30559
    Germany

    Site Not Available

  • Novartis Investigative Site

    Lübeck, 23538
    Germany

    Site Not Available

  • Novartis Investigative Site

    Münster, 48149
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dublin, DUBLIN 9
    Ireland

    Site Not Available

  • Novartis Investigative Site

    Milan, MI 20138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Modena, MO 41126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pisa, PI 56126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pisa 3170647, PI 56124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Torino, TO 10126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Novartis Investigative Site

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Novartis Investigative Site

    Krakow 3094802, Poland 31 531
    Poland

    Site Not Available

  • Novartis Investigative Site

    Bydgoszcz, 85-163
    Poland

    Site Not Available

  • Novartis Investigative Site

    Krakow, 30-721
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warsaw, 01-684
    Poland

    Site Not Available

  • Novartis Investigative Site

    Warsaw 756135, 01-684
    Poland

    Site Not Available

  • Novartis Investigative Site

    Yangsan, Gyeongsangnam-do 50612
    South Korea

    Site Not Available

  • Novartis Investigative Site

    Seoul, 05505
    South Korea

    Site Not Available

  • Novartis Investigative Site

    Seoul 1835848, 04763
    South Korea

    Site Not Available

  • Novartis Investigative Site

    Santiago Compostela, A Coruna 15706
    Spain

    Site Not Available

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona 3128760, Catalonia 3336901 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, 08035
    Spain

    Site Not Available

  • Novartis Investigative Site

    Valencia, 46026
    Spain

    Site Not Available

  • Novartis Investigative Site

    Malmö, 214 28
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Stockholm, 113 61
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Umeå, SE-90185
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Basel, 4031
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Sankt Gallen, 9007
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Sheffield, South Yorkshire S10 2JF
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Farnborough, BR6 8ND
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London, WC1N 3BG
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London 2643743, SW17 0QT
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Stoke-on-Trent, ST4 6QG
    United Kingdom

    Site Not Available

  • University of California San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • Loma Linda University Health

    Loma Linda, California 92354
    United States

    Site Not Available

  • Keck Medical Center USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • UC San Francisco Medical Center

    San Francisco, California 94143-0348
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Orlando Health Clinical Trials

    Orlando, Florida 32806
    United States

    Site Not Available

  • Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • University Of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Lange Neurology PC

    New York, New York 10065
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Duke University Health System

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Univ of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • AMR Knoxville

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Austin Neuromuscular Center

    Austin, Texas 78759
    United States

    Site Not Available

  • Nerve and Muscle Center of Texas

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

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