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

August 19, 2025 updated by: Vega Therapeutics, Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Queenland
      • Herston, Queenland, Australia, 4029
        • Recruiting
        • Royal Brisbane & Women's Hospital, Queensland Haemophilia Centre
  • Austria
    • Vienna
      • Vienna, Vienna, Austria
        • Completed
        • Medical University of Vienna
  • Brazil
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20211-030
        • Recruiting
        • Centro de Hemoterapia e Hematologia do Rio de Janeiro HEMORIO
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-878
        • Recruiting
        • Hemocentro Unicamp
      • São Paulo, São Paulo, Brazil, 05403-010
        • Recruiting
        • Hospital das Clinicas - USP Endereco
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • Hamilton Health Sciences Corporation
      • Kingston, Ontario, Canada, K7L 3N6
        • Recruiting
        • Queens University
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michaels Hospital
  • India
    • Mumbai
      • Sion, Mumbai, India, 400022
        • Recruiting
        • K J Somaiya Super Speciality Hospital & Research Centre
  • South Africa
      • Johannesburg, South Africa
        • Recruiting
        • Charlotte Maxeke Johannesburg Academic Hospital
  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare NHS Trust- Queen Charlotte's & Chelsea Hospital
    • Edgbaston
      • Birmingham, Edgbaston, United Kingdom, B15 2TT
        • Recruiting
        • Queen Elizabeth Hospital Birmingham
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD.
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
    • London
      • London, London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
      • Whitechapel, London, United Kingdom, E12ES
        • Recruiting
        • Royal London Hospital, Clinical Haematology Research
  • United States
    • California
      • Los Angeles, California, United States, 90007
        • Recruiting
        • Orthopedic Institute for Children (UCLA)
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Hemophilia of Georgia Center for Bleeding & Clotting Disorders of Emory
    • North Carolina
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Science 37, Inc.
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • Hemophilia Center of Western PA
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern
    • Washington
      • Seattle, Washington, United States, 98101
        • Recruiting
        • Washington Center for Bleeding Disorders
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Versiti Comprehensive Center for Bleeding Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria (All Subjects)

  • Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2
  • Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5
  • No clinically significant laboratory, ECG, or vital signs results.

Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2

Additional Key Inclusion Criteria (for Subjects in Part 2 Only)

  • Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.
  • Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening.

Exclusion Key Criteria (All Subjects)

  • Use of hormonal contraceptives within 56 days prior to administration of the study drug.
  • Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
  • Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.
  • History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.
  • Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction.

Additional Key Exclusion Criterion (Subjects in Part 1 Only)

• Baseline FVIII activity > 150 IU/dL.

Additional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)

  • Baseline FVIII activity > 50 IU/dL.
  • Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Part 1
Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined
Drug: VGA039
Single doses of VGA039
Other: Placebo
Single doses of Placebo
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 2
Cohorts A-H IV or SC VGA039 dose to be determined
Drug: VGA039
Single doses of VGA039
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 3
Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined
Drug: VGA039
Single doses of VGA039
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 4
Cohorts of VGA039 single dose for surgical prophylaxis
Drug: VGA039
Single doses of VGA039
Drug: VGA039
Multiple doses of VGA039
Experimental: Part 5
Multiple doses of VGA039 in open label extension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Time Frame: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).
From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Concentrations of single IV and SC doses of VGA039
Time Frame: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Pharmacodynamics of single IV and SC doses of VGA039
Time Frame: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
Incidence of Anti-drug antibodies to VGA039
Time Frame: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vega Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 8, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Estimated)

August 26, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGA039-CP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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