Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
Purpose
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
Conditions
- Eosinophilic Granulomatosis With Polyangiitis
- Churg-Strauss Syndrome
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 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 <500 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NS-229 |
Self-administer NS-229 in consecutive 28 weeks. |
|
|
Placebo Comparator Placebo |
Self-administer matching placebo in consecutive 28 weeks. |
|
Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
More Details
- Status
- Recruiting
- Sponsor
- NS Pharma, Inc.
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 Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without mepolizumab 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.