Ensayos clínicos

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:

1. Estimated glomerular filtration rate of < 30 mL/min/1.73 m^2 by Chronic Kidney
Disease Epidemiology Collaboration equations;

2. WBC count < 4 × 10^9/L;

3. Absolute lymphocyte count < 500 cells/mm^3;

4. Absolute neutrophil count < 500 cells/mm^3;

5. Platelet count < 120,000/mm^3

6. 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/24/23. Questions regarding updates should be directed to the study team contact.