A Phase 3 interventional study of VGA039 in Von Willebrand Disease (VWD), sponsored by Vega Therapeutics, Inc. Recruiting at 32 sites in 10 countries. Open to participants aged 12 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Vega Therapeutics, Inc (part of Incyte Corporation) · Phase 3, Interventional, and Treatment
This is a phase 3 study that will evaluate subcutaneous (SC) VGA039 in patients with von Willebrand Disease (VWD)
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.
96 studies on the registry are indexed under von Willebrand Diseases; 25 are open to participants now.
This study's planned enrollment of 60 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
Key Exclusion Criteria
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.
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.
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.
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.
Participants who meet eligibility criteria and complete a 24-week observational phase will receive VGA039 SC for approximately 49 weeks.
Drug: VGA039
VGA039 SC administered for 49-weeks during the interventional phase following a 24-week observational period.
Incidence of bleeding events [Efficacy]
Time frame: Time Frame: From 7 days after informed consent until 49 weeks after SC study drug initiation
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
Plan to share: No — IPD will not be shared due to legal, ethical, or regulatory restrictions related to the study population or data use agreements.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Oct 2028, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.