Actively Recruiting
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
Led by NS Pharma, Inc. · Updated on 2026-03-25
45
Participants Needed
34
Research Sites
132 weeks
Total Duration
On this page
Sponsors
N
NS Pharma, Inc.
Lead Sponsor
N
Nippon Shinyaku Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis.
CONDITIONS
Official Title
Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide written informed consent prior to participation in the study.
- Male or female subjects aged 6530;18 years at the time the informed consent form is signed.
- Diagnosis of EGPA based on eosinophilia plus at least two additional features of EGPA.
- Receiving background oral glucocorticoid (OGC) dose of 6530;7.5 mg/day with or without stable treatment with Mepolizumab/Benralizumab.
- Use of adequate contraception.
- Other inclusion criteria may apply.
You will not qualify if you...
- Current diagnosis of 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, kidney, blood, or psychiatric disease.
- Severe or uncontrolled cardiovascular disease.
- Active systemic infections including tuberculosis, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections.
- Known parasitic infestation within 6 months prior to screening.
- HIV positive status.
- Active hepatitis B or C infection.
- History or presence of venous thromboembolism or thrombotic events.
- Estimated glomerular filtration rate <30 mL/min/1.73 m2.
- Low blood counts: WBC <4 x 10^9/L, lymphocytes <500 cells/mm3, neutrophils <1000 cells/mm3, platelets <120,000/mm3, hemoglobin <8 g/dL.
- Pregnant, breastfeeding, or planning pregnancy during study participation.
- History of significant drug or alcohol abuse within the last 6 months.
- Other exclusion criteria may apply.
AI-Screening
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Trial Site Locations
Total: 34 locations
1
National Jewish Health
Denver, Colorado, United States, 80206
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
7
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
8
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
9
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N4A6
Active, Not Recruiting
10
University of Toronto
Toronto, Ontario, Canada, M5G 1X5
Actively Recruiting
11
CHU Nice
Nice, France, 06202
Actively Recruiting
12
Hopital Cochin
Paris, France, 75014
Actively Recruiting
13
Chu Rangueil
Toulouse, France, 31059
Actively Recruiting
14
Medius Kliniken gGmbh
Kirchheim unter Teck, Studienzentrale, Germany, 73230
Actively Recruiting
15
Istituto Auxologico Italiano IRCCS
Milan, Italy, 20145
Actively Recruiting
16
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy, 00128
Actively Recruiting
17
Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento
Trento, Italy, 38122
Actively Recruiting
18
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy, 37126
Actively Recruiting
19
Chiba University Hospital
Chuo-ku, Chiba-shi, Chiba, Japan, 260-8677
Actively Recruiting
20
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, Japan, 807-8555
Actively Recruiting
21
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
22
NHO Sagamihara National Hospital
Sagamihara, Kanagawa, Japan, 252-0392
Actively Recruiting
23
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan, 245-8575
Actively Recruiting
24
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
25
Osaka Habikino Medical Center
Habikino, Osaka, Japan, 583-8588
Actively Recruiting
26
Saitama Medical Center
Kawagoe, Saitama, Japan, 350-8550
Actively Recruiting
27
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Actively Recruiting
28
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611
Actively Recruiting
29
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan, 143-8541
Actively Recruiting
30
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain, 15706
Active, Not Recruiting
31
Complejo Hospitalario de Navarra
Pamplona, Spain, 31008
Active, Not Recruiting
32
Queen Elizabeth Hospital Birmingham
Edgbaston, Birmingham, United Kingdom, B15 2GW
Actively Recruiting
33
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 2QQ
Actively Recruiting
34
Royal Berkshire NHS Foundation Trust
Reading, United Kingdom, RG1 5AN
Actively Recruiting
Research Team
N
NS Pharma, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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