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
NS Pharma, Inc.
Summary
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
- Age range
- 18+ years
- Sex
- All
- 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. * 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…
Interventions
- DrugNS-229
Experimental
- DrugPlacebo
Placebo comparator
Locations (34)
- National Jewish HealthDenver, Colorado
- Mayo ClinicRochester, Minnesota
- Cleveland ClinicCleveland, Ohio
- The Ohio State University Wexner Medical CenterColumbus, Ohio
- University of PennsylvaniaPhiladelphia, Pennsylvania
- Medical University of South CarolinaCharleston, South Carolina