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NCT06643481 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Novartis Pharmaceuticals.

Active
Registry status
Phase 2
Development phase
251
Enrollment target
20
Study locations

NCT06643481 is a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 251 participants, roughly in line with the 246-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target. The trial reports 20 study locations across 12 states.

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The verdict

NCT06643481, a Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
251 participants
Enrollment target
20
Study locations

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).

Conditions Studied

Amyotrophic Lateral Sclerosis (ALS)

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

1,375 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, categorized as Phase 2. The registered enrollment target is 251 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 246-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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.

NCT06643481 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Nebraska.

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).

What interventions are being tested in trial NCT06643481?

The interventions under investigation include: Placebo (OTHER), VHB937 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06643481?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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.

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