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 issigned.

• Diagnosis of EGPA: Subjects who have been diagnosed with EGPA based on the historyor presence of eosinophilia plus at least a history or presence of 2 of additionalfeatures of EGPA.

• Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatmentwith mepolizumab.

• Use of adequate contraception.

• Other inclusion criteria may apply.

Exclusion Criteria:

• Current diagnosis of either granulomatosis with polyangiitis or microscopicpolyangiitis

• 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 standardtreatment

• Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis,and opportunistic infections)

• Parasitic infection: Subjects with a known parasitic infestation within 6 monthsprior 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 (deepvein thrombosis and/or pulmonary embolus)

• laboratory parameter exclusions:

1. Estimated glomerular filtration rate of <30 mL/min/1.73 m2 by Chronic KidneyDisease Epidemiology Collaboration equations

2. WBC count <4 × 109/L

3. Absolute lymphocyte count <500 cells/mm3

4. Absolute neutrophil count <1000 cells/mm3

5. Platelet count <120,000/mm3

6. Hemoglobin <8 g/dL (<80 g/L)

• Subjects who are pregnant, breastfeeding, or planning to become pregnant during thetime of study participation

• History of clinically significant drug or alcohol abuse within the last 6 months

• Other exclusion criteria may apply.