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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - Ability to provide written willing to sign a consent form prior to participation in the study. - Male or female subjects aged ≥18 years at the time the willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

NS-229

Experimental

DRUG

Placebo

Placebo comparator

Locations (20)

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