Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug VHB937 aims to slow ALS progression in Early-Stage patients

NCT ID NCT06643481

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether the experimental drug VHB937 can slow the decline in function and delay the need for breathing support in people with early-stage ALS. About 251 participants will receive either VHB937 or a placebo for 40 weeks, followed by an open-label extension where everyone can get the drug. The study is currently active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VHB937 (a biologic drug given by infusion)
What this could lead to
If it works, this could point toward a treatment that slows the progression of ALS and delays the need for breathing support.
What could go wrong
This is a mid-stage trial with only 251 people, so results may not apply to all ALS patients. The drug may not show benefit over placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

251 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Amyotrophic lateral sclerosis (ALS) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis motor neuron disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amyotrophic lateral sclerosis (ALS)

Contacts and locations

Locations

  • AMR Knoxville

    Knoxville, Tennessee, 37920, United States

  • Atrium Health

    Charlotte, North Carolina, 28207, United States

  • Austin Neuromuscular Center

    Austin, Texas, 78759, United States

  • Duke University Health System

    Durham, North Carolina, 27710, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Keck Medical Center USC

    Los Angeles, California, 90033, United States

  • Lange Neurology PC

    New York, New York, 10065, United States

  • Loma Linda University Health

    Loma Linda, California, 92354, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • Novartis Investigative Site

    North Ryde, New South Wales, 2109, Australia

  • Novartis Investigative Site

    Herston, Queensland, 4029, Australia

  • Novartis Investigative Site

    Caulfield South, Victoria, 3162, Australia

  • Novartis Investigative Site

    Southport, 4215, Australia

  • Novartis Investigative Site

    Leuven, Vlaams Brabant, 3000, Belgium

  • Novartis Investigative Site

    Liège, 4000, Belgium

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N1, Canada

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3T2, Canada

  • Novartis Investigative Site

    Beijing, 100191, China

  • Novartis Investigative Site

    Aalborg, 9000, Denmark

  • Novartis Investigative Site

    Kobenhavn N V, 2400, Denmark

  • Novartis Investigative Site

    Bron, 69677, France

  • Novartis Investigative Site

    Lille, 59037, France

  • Novartis Investigative Site

    Nice, 06001, France

  • Novartis Investigative Site

    Paris, 75013, France

  • Novartis Investigative Site

    Tours, 37044, France

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68167, Germany

  • Novartis Investigative Site

    Munich, Bavaria, 81675, Germany

  • Novartis Investigative Site

    Würzburg, Bavaria, 97080, Germany

  • Novartis Investigative Site

    Rostock, Mecklenburg-Vorpommern, 18057, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Hanover, 30559, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Münster, 48149, Germany

  • Novartis Investigative Site

    Ulm, 89081, Germany

  • Novartis Investigative Site

    Dublin, DUBLIN 9, Ireland

  • Novartis Investigative Site

    Milan, MI, 20138, Italy

  • Novartis Investigative Site

    Modena, MO, 41126, Italy

  • Novartis Investigative Site

    Pisa, PI, 56126, Italy

  • Novartis Investigative Site

    Torino, TO, 10126, Italy

  • Novartis Investigative Site

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    Krakow, Poland, 31 531, Poland

  • Novartis Investigative Site

    Bydgoszcz, 85-163, Poland

  • Novartis Investigative Site

    Krakow, 30-721, Poland

  • Novartis Investigative Site

    Warsaw, 01-684, Poland

  • Novartis Investigative Site

    Warsaw, 02-473, Poland

  • Novartis Investigative Site

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Novartis Investigative Site

    Seoul, 04763, South Korea

  • Novartis Investigative Site

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    Santiago Compostela, A Coruna, 15706, Spain

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Valencia, 46026, Spain

  • Novartis Investigative Site

    Malmö, 214 28, Sweden

  • Novartis Investigative Site

    Stockholm, 113 61, Sweden

  • Novartis Investigative Site

    Umeå, SE-90185, Sweden

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Sankt Gallen, 9007, Switzerland

  • Novartis Investigative Site

    Sheffield, South Yorkshire, S10 2JF, United Kingdom

  • Novartis Investigative Site

    Farnborough, BR6 8ND, United Kingdom

  • Novartis Investigative Site

    London, SW17 0QT, United Kingdom

  • Novartis Investigative Site

    London, WC1N 3BG, United Kingdom

  • Novartis Investigative Site

    Stoke-on-Trent, ST4 6QG, United Kingdom

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • UC San Francisco Medical Center

    San Francisco, California, 94143-0348, United States

  • Univ of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University Of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of California San Diego

    La Jolla, California, 92037, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.