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Clinical Trials in the UK / NCT06643481
Active, not recruiting Phase 2

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

NCT06643481 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2024-10-17
Last updated
2026-07-07

Condition(s) studied

Amyotrophic Lateral Sclerosis (ALS)

Investigational drug(s) / intervention(s)

VHB937Placebo

VHB937: VHB937 solution for infusion

Placebo: Solution for infusion

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (74)

FacilityCityRegionStatus
University of California San Diego La Jolla California
Loma Linda University Health Loma Linda California
Keck Medical Center USC Los Angeles California
UC San Francisco Medical Center San Francisco California
University of Miami Miami Florida
Orlando Health Clinical Trials Orlando Florida
Emory University School of Medicine Atlanta Georgia
University Of Kansas Medical Center Kansas City Kansas
Massachusetts General Hospital Boston Massachusetts
University of Nebraska Medical Center Omaha Nebraska
Lange Neurology PC New York New York
University of Rochester Medical Center Rochester New York
Atrium Health Charlotte North Carolina
Duke University Health System Durham North Carolina
Univ of Cincinnati Medical Center Cincinnati Ohio
The Ohio State University Columbus Ohio
Temple University Philadelphia Pennsylvania
AMR Knoxville Knoxville Tennessee
Austin Neuromuscular Center Austin Texas
Nerve and Muscle Center of Texas Houston Texas
University of Washington Medical Center Seattle Washington
Novartis Investigative Site North Ryde New South Wales
Novartis Investigative Site Herston Queensland
Novartis Investigative Site Caulfield South Victoria
Novartis Investigative Site Southport Australia
Novartis Investigative Site Leuven Vlaams Brabant
Novartis Investigative Site Liège Belgium
Novartis Investigative Site Calgary Alberta
Novartis Investigative Site Montreal Quebec
Novartis Investigative Site Beijing China
Novartis Investigative Site Aalborg Denmark
Novartis Investigative Site Kobenhavn N V Denmark
Novartis Investigative Site Bron France
Novartis Investigative Site Lille France
Novartis Investigative Site Nice France
Novartis Investigative Site Paris France
Novartis Investigative Site Tours France
Novartis Investigative Site Mannheim Baden-Wurttemberg
Novartis Investigative Site Munich Bavaria
Novartis Investigative Site Würzburg Bavaria

+ 34 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06643481 on ClinicalTrials.gov ↗ ← All trials in the UK