Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis

Inclusion Criteria: Ability to provide written informed consent prior to participation in the study. Male or female subjects aged ≥18 years at the time the informed consent form is signed. Diagnosis of EGPA: Subjects who have been diagnosed with EGPA based on the history or presence of eosinophilia plus at least a history or presence of 2 of additional features of EGPA. Use of adequate contraception. Other inclusion criteria may apply. Exclusion Criteria: Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis Imminently life-threatening EGPA at the time of screening. History or presence of any form of cancer within 5 years prior to screening. Serious liver, renal, blood, or psychiatric disease Severe or clinically significant cardiovascular disease uncontrolled with standard treatment Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections) Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening. HIV positive status Active hepatitis due to hepatitis B virus or hepatitis C virus Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus) laboratory parameter exclusions: Estimated glomerular filtration rate of <30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations WBC count <4 × 109/L Absolute lymphocyte count <500 cells/mm3 Absolute neutrophil count <500 cells/mm3 Platelet count <120,000/mm3 Hemoglobin <8 g/dL (<80 g/L) Subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation History of clinically significant drug or alcohol abuse within the last 6 months Other exclusion criteria may apply.