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Clinical Trials in the UK / NCT06046222
Active, not recruiting Phase 2

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

NCT06046222 · tracked via the Priya Life Science UK tracker
Sponsor
NS Pharma, Inc.
Phase
Phase 2
Started
2023-12-20
Last updated
2026-05-26

Condition(s) studied

Eosinophilic Granulomatosis With PolyangiitisChurg-Strauss Syndrome

Investigational drug(s) / intervention(s)

NS-229Placebo

NS-229: Experimental

Placebo: Placebo comparator

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Current diagnosis of either 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, 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 * Other exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (34)

FacilityCityRegionStatus
National Jewish Health Denver Colorado
Mayo Clinic Rochester Minnesota
Cleveland Clinic Cleveland Ohio
The Ohio State University Wexner Medical Center Columbus Ohio
University of Pennsylvania Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
Vanderbilt University Medical Center Nashville Tennessee
University of Alberta Edmonton Alberta
St Joseph's Healthcare Hamilton Hamilton Ontario
University of Toronto Toronto Ontario
CHU Nice Nice France
Hopital Cochin Paris France
Chu Rangueil Toulouse France
Medius Kliniken gGmbh Kirchheim unter Teck Studienzentrale
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
Hospital of the University of Occupational and Environmental Health, Japan Kitakyushu Fukuoka
Hokkaido University Hospital Sapporo Hokkaido
NHO Sagamihara National Hospital Sagamihara Kanagawa
National Hospital Organization Yokohama Medical Center Yokohama Kanagawa
Tohoku University Hospital Sendai Miyagi
Osaka Habikino Medical Center Habikino Osaka
Saitama Medical Center Kawagoe Saitama
Juntendo University Hospital Bunkyo-ku Tokyo
Kyorin University Hospital Mitaka Tokyo
Toho University Omori Medical Center Ōta-ku Tokyo
Complejo Hospitalario Universitario de Santiago de Compostela Santiago de Compostela A Coruna
Complejo Hospitalario de Navarra Pamplona Spain
Queen Elizabeth Hospital Birmingham Edgbaston Birmingham
Addenbrookes Hospital Cambridge United Kingdom
Royal Berkshire NHS Foundation Trust Reading United Kingdom

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06046222 on ClinicalTrials.gov ↗ ← All trials in the UK