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

Churg-Strauss Syndrome Clinical Trial

Official title:
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

Clinical Trial Summary

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06046222
Study type Interventional
Source NS Pharma, Inc.
Contact NS Pharma, Inc.
Phone 1-866-677-4276
Email trialinfo@nspharma.com
Status Recruiting
Phase Phase 2
Start date December 20, 2023
Completion date May 2025
View Details
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