Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis
NCT ID: NCT06046222
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2023-12-20
2026-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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NS-229
Self-administer NS-229 in consecutive 28 weeks.
NS-229
Experimental
Placebo
Self-administer matching placebo in consecutive 28 weeks.
Placebo
Placebo comparator
Interventions
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NS-229
Experimental
Placebo
Placebo comparator
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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, renal, blood, or psychiatric disease
* Severe or clinically significant cardiovascular disease uncontrolled with standard treatment
* Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections)
* Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening.
* HIV positive status
* Active hepatitis due to hepatitis B virus or hepatitis C virus
* Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus)
* laboratory parameter exclusions:
1. Estimated glomerular filtration rate of \<30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations
2. WBC count \<4 × 109/L
3. Absolute lymphocyte count \<500 cells/mm3
4. Absolute neutrophil count \<1000 cells/mm3
5. Platelet count \<120,000/mm3
6. Hemoglobin \<8 g/dL (\<80 g/L)
* Subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation
* History of clinically significant drug or alcohol abuse within the last 6 months
18 Years
ALL
No
Sponsors
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Nippon Shinyaku Co., Ltd.
INDUSTRY
NS Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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National Jewish Health
Denver, Colorado, United States
Mayo Clinic
Rochester, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Alberta
Edmonton, Alberta, Canada
St Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
University of Toronto
Toronto, Ontario, Canada
CHU Nice
Nice, , France
Hopital Cochin
Paris, , France
Chu Rangueil
Toulouse, , France
Medius Kliniken gGmbh
Kirchheim unter Teck, Studienzentrale, Germany
Istituto Auxologico Italiano IRCCS
Milan, , Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, , Italy
Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento
Trento, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Chiba University Hospital
Chuo-ku, Chiba-shi, Chiba, Japan
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
NHO Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center
Yokohama, Kanagawa, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Osaka Habikino Medical Center
Habikino, Osaka, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Kyorin University Hospital
Mitaka, Tokyo, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Queen Elizabeth Hospital Birmingham
Edgbaston, Birmingham, United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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NS229-P2-01
Identifier Type: -
Identifier Source: org_study_id
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