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ACTIVE NOT RECRUITING Phase 2

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

NCT06643481 · View on ClinicalTrials.gov ↗

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).

Interventions

  • OTHER Placebo
  • BIOLOGICAL VHB937

Study Locations (20)

California

  • University of California San Diego — La Jolla
  • Loma Linda University Health — Loma Linda
  • Keck Medical Center USC — Los Angeles
  • UC San Francisco Medical Center — San Francisco

Florida

  • University of Miami — Miami
  • Orlando Health Clinical Trials — Orlando

Nebraska

  • Neurology Associates P C — Lincoln
  • University of Nebraska Medical Center — Omaha

New York

  • Lange Neurology PC — New York
  • University of Rochester Medical Center — Rochester

North Carolina

  • Atrium Health — Charlotte
  • Duke University Health System — Durham

Ohio

  • Univ of Cincinnati Medical Center — Cincinnati
  • The Ohio State University — Columbus

Georgia

  • Emory University School of Medicine — Atlanta

Kansas

  • University Of Kansas Medical Center — Kansas City

Trial Details

FieldValue
Enrollment Target 251 participants
Start Date 2024-10-17
Est. Completion 2028-07-07
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06643481

The ClinicalTrials.gov registry entry for NCT06643481 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 251 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Amyotrophic Lateral Sclerosis (ALS) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06643481 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06643481 about?

NCT06643481 is a clinical study titled "A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)". 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...

What is the current status of trial NCT06643481?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 251 participants. The study started on 2024-10-17. Estimated completion is 2028-07-07.

What conditions does trial NCT06643481 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis (ALS). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06643481?

The interventions under investigation include: Placebo (OTHER), VHB937 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06643481?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06643481 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial