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Updated May 2026 · ClinicalTrials.gov

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

Trial of Efficacy and Safety of NS-229 Versus Placebo in Patients With Eosinophilic Granulomatosis With Polyangiitis (NCT06046222) is a Phase 2 interventional studying Eosinophilic Granulomatosis With Polyangiitis and Churg-Strauss Syndrome, sponsored by NS Pharma, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Eosinophilic Granulomatosis With Polyangiitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 45 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

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.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06046222), the sponsor (NS Pharma, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06046222 clinical trial studying?

This study will enroll male and female subjects who are 18 years of age or older with Eosinophilic Granulomatosis With Polyangiitis. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06046222?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06046222?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06046222. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06046222. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.