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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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).

Key facts

Study ID

NCT06643481

Run by

Novartis Pharmaceuticals

People needed

251

Starts

2024-10-17

Expected to finish

2028-07-10

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Loma Linda University Health — Loma Linda, California, United States
• Keck Medical Center USC — Los Angeles, California, United States
• UC San Francisco Medical Center — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Orlando Health Clinical Trials — Orlando, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• University Of Kansas Medical Center — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Lange Neurology PC — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• Duke University Health System — Durham, North Carolina, United States
• Univ of Cincinnati Medical Center — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Temple University — Philadelphia, Pennsylvania, United States
• AMR Knoxville — Knoxville, Tennessee, United States
• Austin Neuromuscular Center — Austin, Texas, United States
• Nerve and Muscle Center of Texas — Houston, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Novartis Investigative Site — North Ryde, New South Wales, Australia
• Novartis Investigative Site — Herston, Queensland, Australia
• Novartis Investigative Site — Caulfield South, Victoria, Australia
• Novartis Investigative Site — Southport, Australia
• University of California San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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