Clinical Trials in Germany / 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 Germany tracker
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
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)
- The proportion of subjects in remission [OGC 4.0] — From Baseline to week 28
The proportion of subjects in remission (oral glucocorticoid \[OGC\] 4.0) at Week 28 of the study treatment period. Definition of remission (OGC 4.0): BVAS of 0 AND OGC dose of prednisolone/prednisone ≤4 mg/day
Trial sites (34)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Germany