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

NCT06046222 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NS229-P2-01
• Study Type: interventional
• Target: 45
• Locations: 8 countries
• Sites: 34

Brief Summary

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

Conditions

Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome

Outcome Measures

Primary Outcomes (1)

• The proportion of subjects in remission [OGC 4.0]

  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

  From Baseline to week 28

Secondary Outcomes (3)

• The proportion of subjects in remission [OGC 7.5]

  From Baseline to week 28

• Time to first relapse of EGPA

  Up to Week 28

• Time to first worsening of EGPA

  Up to Week 28

Study Arms (2)

NS-229

EXPERIMENTAL

Self-administer NS-229 in consecutive 28 weeks.

Drug: NS-229

Placebo

PLACEBO COMPARATOR

Self-administer matching placebo in consecutive 28 weeks.

Drug: Placebo

Interventions

NS-229 DRUG

Experimental

NS-229

Placebo DRUG

Placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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)
• 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

Sponsors & Collaborators

• NS Pharma, Inc.: lead
• Nippon Shinyaku Co., Ltd.: collaborator

Study Sites (34)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N4A6, Canada

ACTIVE NOT RECRUITING

University of Toronto

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

CHU Nice

Nice, 06202, France

RECRUITING

Hopital Cochin

Paris, 75014, France

RECRUITING

Chu Rangueil

Toulouse, 31059, France

RECRUITING

Medius Kliniken gGmbh

Kirchheim unter Teck, Studienzentrale, 73230, Germany

RECRUITING

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

RECRUITING

Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento

Trento, 38122, Italy

RECRUITING

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

RECRUITING

Chiba University Hospital

Chuo-ku, Chiba-shi, Chiba, 260-8677, Japan

RECRUITING

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu, Fukuoka, 807-8555, Japan

RECRUITING

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

RECRUITING

NHO Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

RECRUITING

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan

RECRUITING

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Osaka Habikino Medical Center

Habikino, Osaka, 583-8588, Japan

RECRUITING

Saitama Medical Center

Kawagoe, Saitama, 350-8550, Japan

RECRUITING

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Kyorin University Hospital

Mitaka, Tokyo, 181-8611, Japan

RECRUITING

Toho University Omori Medical Center

Ōta-ku, Tokyo, 143-8541, Japan

RECRUITING

Complejo Hospitalario Universitario de Santiago de Compostela

Santiago de Compostela, A Coruna, 15706, Spain

ACTIVE NOT RECRUITING

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

ACTIVE NOT RECRUITING

Queen Elizabeth Hospital Birmingham

Edgbaston, Birmingham, B15 2GW, United Kingdom

RECRUITING

Addenbrookes Hospital

Cambridge, CB2 2QQ, United Kingdom

RECRUITING

Royal Berkshire NHS Foundation Trust

Reading, RG1 5AN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Churg-Strauss Syndrome

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

NS Pharma, Inc.

CONTACT

1-866-677-4276; trialinfo@nspharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: December 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); JP (11); CA (3); FR (3); IT (4); US (7); GB (3); ES (2)