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
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
National Jewish Health
RECRUITING
Denver
Minnesota
Mayo Clinic
RECRUITING
Rochester
Ohio
Cleveland Clinic
RECRUITING
Cleveland
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Other Locations
Canada
University of Alberta
RECRUITING
Edmonton
St Joseph's Healthcare Hamilton
RECRUITING
Hamilton
University of Toronto
RECRUITING
Toronto
France
CHU Nice
RECRUITING
Nice
Hopital Cochin
RECRUITING
Paris
Chu Rangueil
RECRUITING
Toulouse
Germany
Medius Kliniken gGmbh
RECRUITING
Kirchheim Unter Teck
Italy
Istituto Auxologico Italiano IRCCS
RECRUITING
Milan
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento
RECRUITING
Trento
Azienda Ospedaliera Universitaria Integrata Verona
RECRUITING
Verona
Japan
Juntendo University Hospital
RECRUITING
Bunkyo-ku
Chiba University Hospital
RECRUITING
Chuo-ku, Chiba-shi
Osaka Habikino Medical Center
RECRUITING
Habikino
Saitama Medical Center
RECRUITING
Kawagoe
Hospital of the University of Occupational and Environmental Health, Japan
RECRUITING
Kitakyushu
Kyorin University Hospital
RECRUITING
Mitaka
Toho University Omori Medical Center
RECRUITING
Ōta-ku
NHO Sagamihara National Hospital
RECRUITING
Sagamihara
Hokkaido University Hospital
RECRUITING
Sapporo
Tohoku University Hospital
RECRUITING
Sendai
National Hospital Organization Yokohama Medical Center
RECRUITING
Yokohama
Spain
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
Complejo Hospitalario Universitario de Santiago de Compostela
RECRUITING
Santiago De Compostela
United Kingdom
Addenbrookes Hospital
RECRUITING
Cambridge
Queen Elizabeth Hospital Birmingham
RECRUITING
Edgbaston
Royal Berkshire NHS Foundation Trust
RECRUITING
Reading
Contact Information
Primary
NS Pharma, Inc.
trialinfo@nspharma.com
1-866-677-4276
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-07
Participants
Target number of participants: 45
Treatments
Experimental: NS-229
Self-administer NS-229 in consecutive 28 weeks.
Placebo_comparator: Placebo
Self-administer matching placebo in consecutive 28 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Nippon Shinyaku Co., Ltd.
Leads: NS Pharma, Inc.