NCT06046222

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: NS Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Eosinophilic Granulomatosis With Polyangiitis
• Churg-Strauss Syndrome

Interventions

Type	Name	Description
DRUG	NS-229	Experimental
DRUG	Placebo	Placebo comparator

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2023-09-21
• Last updated: 2026-03-25

Locations

34 sites across 8 countries: United States, Canada, France, Germany, Italy, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study