Study to Evaluate Subcutaneous (SC) VGA039 in Subjects With Von Willebrand Disease (VWD) (VIVID-6)..

Launched by VEGA THERAPEUTICS, INC · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new medicine called VGA039, given as an injection under the skin, to help people with von Willebrand Disease (VWD), a condition that makes it harder for blood to clot and can cause frequent bleeding. The study is in Phase 3, which means it’s one of the final steps to see if the treatment is safe and works well. The goal is to find out if VGA039 can reduce how often people with VWD experience bleeding episodes.

To join the study, participants need to be between 12 and 75 years old and have a confirmed diagnosis of VWD with a history of frequent bleeding (at least 12 bleeding events per year, not counting menstrual or skin bruises). They should be healthy enough based on blood tests and other medical checks, and not currently using regular preventive treatments for bleeding. If accepted, participants will receive the study drug and be monitored to see how well it helps reduce bleeding and if there are any side effects. It’s important to know that people with certain health problems, like blood clots or serious organ diseases, won’t be eligible to join. This study is not yet recruiting, but it aims to offer a new way to help people with VWD manage their condition better.

Gender

ALL

Eligibility criteria

• • Key Inclusion Criteria
• • 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
• • Key Exclusion Criteria
• • 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)