NCT06643481Active, not recruitingPhase 2
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)
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)
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 251 (actual)
- First submitted
- 30 Sept 2024
- Start date
- Oct 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06643481
- EU CT number
- 2024-512536-29-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 251
- From Oct 2024 to the primary completion date, Jun 2026
- 79 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Taking any prohibited medications
Other illness
- 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.
- 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.
- 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.
Lab values
- Laboratory evidence of hematological abnormalities
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (79)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Caulfield South | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | North Ryde | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Southport | Australia | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Centre Hospitalier Regional de la Citadelle Coordinator of this site? Confirm its status | Liège | Belgium | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| DIAKOVERE Krankenhaus gGmbH Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Active, not recruiting |
| Heidelberg University Coordinator of this site? Confirm its status | Mannheim | Germany | Active, not recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Active, not recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Active, not recruiting |
| Rostock University Medical Center Coordinator of this site? Confirm its status | Rostock | Germany | Active, not recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Active, not recruiting |
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Active, not recruiting |
| Region Hovedstaden Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Active, not recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Active, not recruiting |
| Hospital Carlos III Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Hospitalier Et Universitaire De Limoges Coordinator of this site? Confirm its status | Limoges Cedex 1 | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Farnborough | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Stoke-on-Trent | United Kingdom | Unknown status |
| Beaumont Hospital Coordinator of this site? Confirm its status | Dublin 9 | Ireland | Active, not recruiting |
| Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. Sb Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Active, not recruiting |
| Centrum Medyczne Neuromed Sp. z.o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Linden Sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| City Clinic Research Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| NeuroProtect Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| University Of Skane Coordinator of this site? Confirm its status | Malmo | Sweden | Active, not recruiting |
| Region Stockholm – SLSO Coordinator of this site? Confirm its status | Stockholm | Sweden | Active, not recruiting |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Active, not recruiting |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Austin Neuromuscular Center Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Atrium Health Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Univ of Cincinnati Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Ohio State University Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Duke University Health System Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Nerve and Muscle Center of Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| AMR Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Loma Linda University Health Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Keck Medical Center USC Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Lange Neurology PC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| Orlando Health Clinical Trials Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Temple University Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| UC San Francisco Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Washington Medical Center Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.