NCT05776069

Study of VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease (VIVID)

A Multi-Modular Trial to Evaluate VGA039 in Healthy Volunteers and Patients With Von Willebrand Disease and Other Bleeding Disorders (VIVID)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Vega Therapeutics, Inc · Industry
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.

Detailed description

This first-in-human study consists of 5 parts based on the subject population. Part 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) evaluation of IV or SC VGA039 or placebo in up to 8 cohorts in healthy volunteers. Part 2 is an open-label, SAD of SC or IV VGA039 in up to 8 cohorts in subjects diagnosed with VWD. All participants will be enrolled, treated, and followed up for 15 weeks (IV SAD) or 8 weeks(SC SAD). Part 3 is an open-label, Phase 1b study of SC multiple doses (MD) of VGA039 in up to 4 cohorts. Part 4 is an open-label, Phase 2 study of SC single, surgical prophylaxis (SP) doses of VGA039 administered prior to a minor surgical procedure in subjects diagnosed with VWD in up to 2 cohorts. Part 5 is an open-label extension (OLE) study of SC MD of VGA039 in eligible subjects diagnosed with VWD who have previously participated in a VGA039 interventional trial.

Conditions

• Von Willebrand Diseases

Interventions

Type	Name	Description
DRUG	VGA039	Single doses of VGA039
OTHER	Placebo	Single doses of Placebo
DRUG	VGA039	Multiple doses of VGA039

Timeline

• Start date: 2023-03-16
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2023-03-20
• Last updated: 2025-08-26

Locations

25 sites across 8 countries: United States, Australia, Austria, Brazil, Canada, India, South Africa, United Kingdom

Regulatory

• FDA-regulated drug study