Overview
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
Description
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study treatment period in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without Mepolizumab/Benralizumab therapy. During the treatment period corticosteroid dose will be tapered.
The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone.
Eligibility
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.
- Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatment with Mepolizumab/Benralizumab.
- 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 \<1000 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.
