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

Conditions de participation

• Sexe:

  ALL

• Âges admissibles:

  18 and up

Critères de participation

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.
* 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 m2 by Chronic Kidney Disease 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 the time of study participation
* History of clinically significant drug or alcohol abuse within the last 6 months
* Other exclusion criteria may apply.