NCT07115004

Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)

A Prospective, Multicenter, Open-label, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Prophylactic VGA039 in Adolescent and Adult Patients With Von Willebrand Disease (VIVID-6)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vega Therapeutics, Inc · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)

Detailed description

This Phase 3 multicenter, open-label, single-sequence cross-over study will investigate the safety and efficacy of subcutaneous administration of VGA039 as prophylaxis for bleeding in patients with every type of VWD. The study consists of an Observational Period of at least 24 weeks followed by an Active Treatment Period of approximately 49 weeks of VGA039 treatment. Bleeding data and details of treatments used will be collected from each patient during both study periods. The number, duration, location, and types of bleeds experienced, as well as treatments for bleeds, will be recorded in patient diaries. Adverse events will also be monitored and recorded throughout both study periods.

Conditions

• Von Willebrand Disease (VWD)

Interventions

Type	Name	Description
DRUG	VGA039	VGA039 SC administered for 49-weeks during the interventional phase following a 24-week observational period.

Timeline

• Start date: 2025-10-15
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2025-08-11
• Last updated: 2026-04-03

Locations

14 sites across 4 countries: United States, Georgia, Germany, South Africa

Regulatory

• FDA-regulated drug study