Von Willebrand Disease (VWD)Phase 3VIVID-6NCT07115004
Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)
A Phase 3 study testing VGA039 in people with Von Willebrand Disease (VWD), run by Vega Therapeutics, Inc at 32 sites in 10 countries.
Trial summary
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD) Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Von Willebrand Disease (VWD)
- What is being tested?
- VGA039
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 32 sitesin 10 countries
- Study dates
- 15 Oct 2025to Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 to 75 years of age, inclusive
- No clinically significant laboratory, ECG, or vital signs results
- Documented diagnosis consistent with VWD of any type
- Historical annualized bleeding rate (ABR; excluding menstrual bleeds and bleeds under the skin) of both untreated and treated bleeds ≥12 per year
- Patients with VWD who are judged by the investigator to be suitable candidates for routine prophylaxis to reduce the frequency of bleeding episodes
- Hemoglobin level ≥ 8 g/dL and platelet count ≥ 100 x 109/L at Screening
Who cannot join
- Use of routine prophylaxis of VWF-containing concentrates defined as at least 1 VWF-containing concentrate infusion to prevent or reduce bleeding per week during the previous 6 months prior to screening
- Planning to initiate routine prophylaxis with VWF-containing concentrates or any other hemostatic treatment during the study
- Patients with pro-thrombotic disorders or abnormal findings on laboratory thrombophilia evaluation performed at screening or previously documented
- 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
- Baseline FVIII activity > lower limit of normal (LLN)
Trial locations and contacts
32 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 10 countries
United States14 sites, 14 recruiting
- Recruiting
University of Michigan Health
Ann Arbor, Michigan, 48109
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30308
Emory University Hospital, (404) 686-0277
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
- Recruiting
UT Southwestern Children's Hospital
Dallas, Texas, 75235
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
- Recruiting
Luskin Orthopaedic Institute For Children
Los Angeles, California, 90007
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Science 37, Inc. (Virtual Clinical MetaSite)
Morrisville, North Carolina, 27560
Science 37 Recruitment Team, 1-855-737-3711, recruitment@science37.com
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06510
- Recruiting
Stanford University
Palo Alto, California, 94304
- Recruiting
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, 15213
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
- Recruiting
University of California San Francisco
San Francisco, California, 94143
- Recruiting
Washington Center for Bleeding Disorders
Seattle, Washington, 98101
Research@WACBD.org
Brazil4 sites, 4 recruiting
- Recruiting
emocentro UNICAMP (Centro de Hematologia e Hemoterapia da UNICAMP), University of Campinas (UNICAMP)
Campinas, São Paulo, 13083-878
- Recruiting
Multihemo - Oncoclínicas
Recife, Pernambuco
- Recruiting
Centro de Hemoterapia e Hematologia do Rio de Janeiro (HEMORIO)
Rio de Janeiro, Rio de Janeiro, 20211-030
- Recruiting
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HC-FMUSP)
São Paulo, São Paulo, 05403
Australia3 sites, 3 recruiting
- Recruiting
Royal Brisbane & Women's Hospital (RBWH), Queensland Haemophilia Centre
Brisbane, Queensland, 4029
- Recruiting
The Alfred Hospital (Alfred Health),Monash University
Melbourne, Victoria, 3004
- Recruiting
Royal Prince Alfred Hospital, Institute of Haematology
Sydney, New South Wales (nsw), 2050
Germany2 sites, 2 recruiting
- Recruiting
Vivantes Klinikum im Friedrichshain
Berlin, 10249
- Recruiting
Frankfurt University Hospital (Universitätsmedizin Frankfurt)
Frankfurt, 60596
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria Careggi (Careggi University Hospital)
Florence, 50134
- Recruiting
University of Milan
Milan, Milan, 20122
South Africa2 sites, 2 recruiting
- Recruiting
Worthwhile Clinical Trials Lakeview Hospital
Benoni, Gauteng, 1501
- Recruiting
Charlotte Maxeke Johannesburg Academic Hospital School of Pathology Clinical Haematologist
Johannesburg, 2194
United Kingdom2 sites, 2 recruiting
- Recruiting
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, Greater London, W12 0HS
- Recruiting
Royal Free London NHS Foundation Trust,
London, London, NW3 2QG
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Georgia1 site, 1 recruiting
- Recruiting
K Eristavi National Center of Experimental and Clinical Surgery (ქირურგიის ეროვნული ცენტრი)
Tbilisi, 0159
Ireland1 site, 1 recruiting
- Recruiting
St. James's Hospital, National Coagulation Centre
Dublin, Dublin, D08 NHY1
About this study
Official title: 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)
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
Read the 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)
- Being tested
- VGA039
- Keywords
- VWD, von Willebrand Disease, VIVID-6, Vega Therapeutics, Incyte Corporation, VGA039, Latarcibart
- Medical subject headings
- von Willebrand Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VGA039Drug
VGA039 SC administered for 49-weeks during the interventional phase following a 24-week observational period.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Doses of VGA039 after observational run-in | Experimental | Participants who meet eligibility criteria and complete a 24-week observational phase will receive VGA039 SC for approximately 49 weeks. Receives: Drug: VGA039 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding events [Efficacy]
Measured: Time Frame: From 7 days after informed consent until 49 weeks after SC study drug initiation
Secondary outcomes (4)
Incidence of treated bleeding events [Efficacy]
Measured: From 7 days from Informed consent until 49 weeks after SC study drug initiation
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including hypersensitivity, anaphylaxis, or anaphylactoid reactions
Measured: From informed consent until 49 weeks after SC study drug initiation
Plasma concentrations of SC doses of VGA039
Measured: From just prior to the start of study drug administration until 49 weeks after SC study drug initiation
Incidence of Anti-drug antibodies to VGA039
Measured: From just prior to the start of study drug administration until 49 weeks after SC study drug initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start15 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Von Willebrand Disease (VWD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The study includes two sequential phases: an initial observational period, during which participants are monitored without receiving study drug, followed by an interventional period where eligible participants are assigned to receive the investigational product VGA039 for approximately 49 weeks. The interventional phase follows a single-group assignment model.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vega Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115004
- Sponsor's protocol ID
- VGA039-CP002
- Acronym
- VIVID-6
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to legal, ethical, or regulatory restrictions related to the study population or data use agreements.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07115004
- Acronym / sponsor ID
- VIVID-6 / VGA039-CP002
- Conditions
- Von Willebrand Disease (VWD)
- Keywords
- VWD, von Willebrand Disease, VIVID-6, Vega Therapeutics, Incyte Corporation, VGA039, Latarcibart
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vega Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study includes two sequential phases: an initial observational period, during which participants are monitored without receiving study drug, followed by an interventional period where eligible participants are assigned to receive the investigational product VGA039 for approximately 49 weeks. The interventional phase follows a single-group assignment model.
| Arm | Type | Receives |
|---|---|---|
| Multiple Doses of VGA039 after observational run-in | Experimental | Drug: VGA039Participants who meet eligibility criteria and complete a 24-week observational phase will receive VGA039 SC for approximately 49 weeks. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 12 to 75 years of age, inclusive
- No clinically significant laboratory, ECG, or vital signs results
- Documented diagnosis consistent with VWD of any type
- Historical annualized bleeding rate (ABR; excluding menstrual bleeds and bleeds under the skin) of both untreated and treated bleeds ≥12 per year
- Patients with VWD who are judged by the investigator to be suitable candidates for routine prophylaxis to reduce the frequency of bleeding episodes
Key exclusion criteria (6 listed)
- Use of routine prophylaxis of VWF-containing concentrates defined as at least 1 VWF-containing concentrate infusion to prevent or reduce bleeding per week during the previous 6 months prior to screening
- Planning to initiate routine prophylaxis with VWF-containing concentrates or any other hemostatic treatment during the study
- Patients with pro-thrombotic disorders or abnormal findings on laboratory thrombophilia evaluation performed at screening or previously documented
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VGA039VGA039 SC administered for 49-weeks during the interventional phase following a 24-week observational period. | Drug | Multiple Doses of VGA039 after observational run-in |
Primary outcome
Incidence of bleeding events [Efficacy]
Time frame: Time Frame: From 7 days after informed consent until 49 weeks after SC study drug initiation
4 secondary outcomes
Incidence of treated bleeding events [Efficacy]
Time frame: From 7 days from Informed consent until 49 weeks after SC study drug initiation
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including hypersensitivity, anaphylaxis, or anaphylactoid reactions
Time frame: From informed consent until 49 weeks after SC study drug initiation
Plasma concentrations of SC doses of VGA039
Time frame: From just prior to the start of study drug administration until 49 weeks after SC study drug initiation
Incidence of Anti-drug antibodies to VGA039
Time frame: From just prior to the start of study drug administration until 49 weeks after SC study drug initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. IPD will not be shared due to legal, ethical, or regulatory restrictions related to the study population or data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
32 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VGA039 in people with Von Willebrand Disease (VWD), run by Vega Therapeutics, Inc at 32 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Brazil, Australia, Germany, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials- Vega Therapeutics (650-466-8041, trialtransparency@incyte.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bleeding events [Efficacy] (time frame: Time Frame: From 7 days after informed consent until 49 weeks after SC study drug initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.