ACTIVE_NOT_RECRUITING

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

Conditions

Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis ALS monoclonal antibody motor neuron disease MND

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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)

Quick Facts

Study Start:2024-10-17

Study Completion:2028-06-20

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06643481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals

STUDY_DIRECTOR

Novartis Pharmaceuticals

Study Locations (Sites)

University of California San Diego

La Jolla, California, 92037

United States

Loma Linda University Health

Loma Linda, California, 92354

United States

Keck Medical Center USC

Los Angeles, California, 90033

United States

UC San Francisco Medical Center

San Francisco, California, 94143

United States

University of Miami

Miami, Florida, 33136

United States

Orlando Health Clinical Trials

Orlando, Florida, 32806

United States

Emory University School of Medicine

Atlanta, Georgia, 30322

United States

University Of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

United States

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Neurology Associates P C

Lincoln, Nebraska, 68506-2960

United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Lange Neurology PC

New York, New York, 10065

United States

University of Rochester Medical Center

Rochester, New York, 14642

United States

Atrium Health

Charlotte, North Carolina, 28207

United States

Duke University Health System

Durham, North Carolina, 27710

United States

Univ of Cincinnati Medical Center

Cincinnati, Ohio, 45219

United States

The Ohio State University

Columbus, Ohio, 43210

United States

Providence ALS Center

Portland, Oregon, 97213

United States

Temple University

Philadelphia, Pennsylvania, 19140

United States

AMR Knoxville

Knoxville, Tennessee, 37920

United States

Austin Neuromuscular Center

Austin, Texas, 78759

United States

Nerve and Muscle Center of Texas

Houston, Texas, 77030

United States

University of Washington Medical Center

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-17

Study Completion Date2028-06-20

Study Record Updates

Study Start Date2024-10-17

Study Completion Date2028-06-20

Terms related to this study

Keywords Provided by Researchers

Amyotrophic Lateral Sclerosis
ALS
monoclonal antibody
motor neuron disease
MND

Additional Relevant MeSH Terms

Amyotrophic Lateral Sclerosis (ALS)