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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
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

Full criteria on ClinicalTrials.gov

Sites (79)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Caulfield SouthAustraliaUnknown status
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HerstonAustraliaUnknown status
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North RydeAustraliaUnknown status
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SouthportAustraliaUnknown status
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Centre Hospitalier Regional de la Citadelle
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LiègeBelgiumActive, not recruiting
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CalgaryCanadaUnknown status
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MontrealCanadaUnknown status
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BaselSwitzerlandUnknown status
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Sankt GallenSwitzerlandUnknown status
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BeijingChinaUnknown status
Charite Universitaetsmedizin Berlin KöR
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BerlinGermanyActive, not recruiting
DIAKOVERE Krankenhaus gGmbH
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HanoverGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyActive, not recruiting
Heidelberg University
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MannheimGermanyActive, not recruiting
Universitaet Muenster
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MuensterGermanyActive, not recruiting
Klinikum rechts der Isar der TU Muenchen AöR
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MunichGermanyActive, not recruiting
Rostock University Medical Center
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RostockGermanyActive, not recruiting
Universitaetsklinikum Ulm AoR
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UlmGermanyActive, not recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyActive, not recruiting
Aalborg University Hospital
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AalborgDenmarkActive, not recruiting
Region Hovedstaden
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Copenhagen NvDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital del Mar
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BarcelonaSpainActive, not recruiting
Hospital Universitario Donostia
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DonostiaSpainActive, not recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Hospital Carlos III
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Turku University Hospital
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TurkuFinlandCompleted
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceActive, not recruiting
Centre Hospitalier Et Universitaire De Limoges
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Limoges Cedex 1FranceActive, not recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceActive, not recruiting
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FarnboroughUnited KingdomUnknown status
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LondonUnited KingdomUnknown status
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SheffieldUnited KingdomUnknown status
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Stoke-on-TrentUnited KingdomUnknown status
Beaumont Hospital
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Dublin 9IrelandActive, 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
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MilanItalyActive, not recruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyActive, not recruiting
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SeoulSouth KoreaUnknown status
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YangsanSouth KoreaUnknown status
Universitair Medisch Centrum Utrecht
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UtrechtNetherlandsActive, not recruiting
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandActive, not recruiting
Linden Sp. z o.o. sp.k.
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CracowPolandActive, not recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandActive, not recruiting
City Clinic Research Sp. z o.o.
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WarsawPolandActive, not recruiting
NeuroProtect Sp. z o.o.
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WarsawPolandActive, not recruiting
University Of Skane
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MalmoSwedenActive, not recruiting
Region Stockholm – SLSO
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StockholmSwedenActive, not recruiting
Region Vaesterbotten
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UmeaSwedenActive, not recruiting
Emory University School of Medicine
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AtlantaUnited StatesUnknown status
Austin Neuromuscular Center
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AustinUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Atrium Health
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CharlotteUnited StatesUnknown status
Univ of Cincinnati Medical Center
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CincinnatiUnited StatesUnknown status
The Ohio State University
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ColumbusUnited StatesUnknown status
Duke University Health System
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DurhamUnited StatesUnknown status
Nerve and Muscle Center of Texas
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HoustonUnited StatesUnknown status
University of Kansas Medical Center
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Kansas CityUnited StatesUnknown status
AMR Knoxville
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KnoxvilleUnited StatesUnknown status
University of California San Diego
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La JollaUnited StatesUnknown status
Loma Linda University Health
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Loma LindaUnited StatesUnknown status
Keck Medical Center USC
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Los AngelesUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Lange Neurology PC
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New YorkUnited StatesUnknown status
University of Nebraska Medical Center
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OmahaUnited StatesUnknown status
Orlando Health Clinical Trials
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OrlandoUnited StatesUnknown status
Temple University
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PhiladelphiaUnited StatesUnknown status
University of Rochester Medical Center
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RochesterUnited StatesUnknown status
UC San Francisco Medical Center
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San FranciscoUnited StatesUnknown status
University of Washington Medical Center
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SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.