Status:
RECRUITING
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
Lead Sponsor:
NS Pharma, Inc.
Collaborating Sponsors:
Nippon Shinyaku Co., Ltd.
Conditions:
Eosinophilic Granulomatosis With Polyangiitis
Churg-Strauss Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
Detailed 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 Granulom...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06046222
Start Date
December 20 2023
End Date
July 1 2026
Last Update
May 22 2025
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
National Jewish Health
Denver, Colorado, United States, 80206
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210