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Efficacy and safety of NS-229 for 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

Phase 2 Interventional NS Pharma, Inc. · NCT06046222

This study is testing if a new medication called NS-229 can help adults with Eosinophilic Granulomatosis With Polyangiitis feel better while reducing their need for corticosteroids.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment45 (estimated)
Ages18 Years and up
SexAll
SponsorNS Pharma, Inc. Industry-sponsored
Drugs / interventionsMepolizumab, Benralizumab, prednisone
Locations34 sites (Denver, Colorado and 33 other locations)
Trial IDNCT06046222 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the efficacy and safety of NS-229 compared to a placebo in patients diagnosed with Eosinophilic Granulomatosis With Polyangiitis (EGPA). It is a randomized, double-blind trial that will enroll adults aged 18 and older who are currently receiving corticosteroid therapy. Over a 28-week treatment period, the study will assess clinical remission defined by the Birmingham Vasculitis Activity Score (BVAS) and will involve tapering corticosteroid doses. Participants may also be receiving stable treatment with Mepolizumab or Benralizumab.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Eosinophilic Granulomatosis With Polyangiitis who are currently on corticosteroid therapy.

Not a fit: Patients with imminent life-threatening EGPA, other forms of vasculitis, or significant comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with EGPA, potentially improving their quality of life and reducing reliance on corticosteroids.

How similar studies have performed: Other studies have shown promise in treating EGPA with similar biologic approaches, indicating potential for success with this novel treatment.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Denver, Colorado and 33 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Eosinophilic Granulomatosis With PolyangiitisChurg-Strauss Syndrome
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.