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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Eosinophilic Granulomatosis With Polyangiitis, Churg-Strauss Syndrome

In brief

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

Key facts

Study ID

NCT06046222

Run by

NS Pharma, Inc.

People needed

45

Starts

2023-12-20

Expected to finish

2026-12-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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:
• Estimated glomerular filtration rate of <30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations
• WBC count <4 × 109/L
• Absolute lymphocyte count <500 cells/mm3
• Absolute neutrophil count <1000 cells/mm3
• Platelet count <120,000/mm3
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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