Study to Evaluate Subcutaneous (SC) VGA039 in Patients With Von Willebrand Disease (VWD)

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)