RecruitingPhase 2NCT06046222
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
Sponsor
NS Pharma, Inc.
Enrollment
45 participants
Start Date
Dec 20, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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.
Exclusion Criteria19
- 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
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Interventions
DRUGNS-229
Experimental
DRUGPlacebo
Placebo comparator
Locations(34)
View Full Details on ClinicalTrials.gov
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NCT06046222