A Phase 1/2 interventional study of VGA039 and Placebo in Von Willebrand Diseases, sponsored by Vega Therapeutics, Inc. Recruiting at 25 sites in 8 countries. Open to participants aged 12 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Vega Therapeutics, Inc (part of Incyte Corporation) · Phase 1/2, Interventional, and Treatment
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.
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.
96 studies on the registry are indexed under von Willebrand Diseases; 25 are open to participants now.
This study's planned enrollment of 116 is above the median of 25 across 41 interventional studies indexed under von Willebrand Diseases.
Browse von Willebrand Diseases studies →Vega Therapeutics, Inc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
First submitted before Vega Therapeutics, Inc became part of Incyte Corporation.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria (All Subjects)
Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • of 18-32 kg/m2
Additional Key Inclusion Criteria (for Subjects in Part 2 Only)
Exclusion Key Criteria (All Subjects)
Additional Key Exclusion Criterion (Subjects in Part 1 Only)
Additional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohorts 1-8 IV or SC VGA039 or Placebo dose to be determined
Drug: VGA039 · Other: Placebo
Cohorts A-H IV or SC VGA039 dose to be determined
Drug: VGA039
Cohorts MD-1 to MD-4, SC VGA039 multiple doses, dose to be determined
Drug: VGA039
Cohorts of VGA039 single dose for surgical prophylaxis
Drug: VGA039
Multiple doses of VGA039 in open label extension
Single doses of VGA039
Single doses of Placebo
Multiple doses of VGA039
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability]
Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs), including dose-limiting toxicities (DLTs).
Time frame: From start of study drug administration until 15 or 8 weeks after IV or SC study drug administration, respectively
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
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
Incidence of Anti-drug antibodies to VGA039
Time frame: From baseline until 15 or 8 weeks after IV or SC study drug administration, respectively
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Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Dec 2029, 81 months after the start.
How these figures are worked out, and which studies are left out of them.
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