Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Amyotrophic Lateral Sclerosis (ALS), sponsored by Novartis Pharmaceuticals.
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, below the 288-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To compare the efficacy of VHB937 vs. placebo on a composite of permanent assisted ventilation (PAV) free survival and function in DB epoch
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2024-10-17 |
| Est. Completion | 2028-07-07 |
| Phase | Phase 2 |
What the registry record for NCT06643481 still lists
NCT06643481 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, below the 288-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (13% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis (ALS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06643481's enrollment target sits among peer trials
251 4th of 18 higher than 15 of 18 other Amyotrophic Lateral Sclerosis (ALS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis (ALS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Mitochondrial Capacity Boost in ALS (MICABO-ALS) Trial
RECRUITING · Phase 2
-
Study of COYA 302 for the Treatment of ALS
RECRUITING · Phase 2
-
PHENOGENE-1A (Cromolyn) Treatment in Patients With Mild to Moderate ALS
RECRUITING · Phase 2
-
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
ACTIVE NOT RECRUITING · Phase 2
-
Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)
COMPLETED · Phase 2
-
Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06043817 · 251 participants · Phase 1
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
- NCT02314988 · 252 participants · Phase 2
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
- NCT03941756 · 252 participants · NA
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
- NCT05219617 · 252 participants · Phase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI