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

Phase 2

Recruiting

• Conditions: Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome
• Interventions: Drug: NS-229; Drug: Placebo

• Registration Number: NCT06046222
• Lead Sponsor: NS Pharma, Inc.

Brief Summary

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

Detailed Description

The purpose of this randomized, double-blind study is to investigate the efficacy and safety of NS229 compared with placebo over a 28-week study treatment period in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving background corticosteroid therapy with or without mepolizumab therapy. During the treatment period corticosteroid dose will be tapered.

The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone.

Study Timeline

• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-14
• Study First Posted: 2023-09-21
• Study Start: 2023-12-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-18
• Primary Completion: 2026-06
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.
• Use of adequate contraception.
• Other inclusion criteria may apply.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NS-229	NS-229	Self-administer NS-229 in consecutive 28 weeks.
Placebo	Placebo	Self-administer matching placebo in consecutive 28 weeks.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects in remission [OGC 7.5]	From Baseline to week 28	The proportion of subjects in remission (OGC 7.5) at Week 28 of the study treatment period Definition of remission (OGC 7.5): BVAS of 0 AND OGC dose of prednisolone/prednisone ≤7.5 mg/day
Time to first worsening of EGPA	Up to Week 28	Worsening of EGPA will be defined as worsening of active disease since the last visit, characterized by: 1. Active vasculitis (BVAS \>0) and the score greater than the previous visit; OR; 2. Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared to the most recent previous score); OR; 3. Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared to the most recent previous assessment).
Time to first relapse of EGPA	Up to Week 28	Relapse of EGPA will be defined as active disease since the last visit after remission (OGC 4.0) was achieved, characterized by: 1. Active vasculitis (BVAS of \>0); OR; 2. Signs and/or symptoms of active asthma with a corresponding worsening in answers on the 6-item Asthma Control Questionnaire (compared with the most recent previous results); OR; 3. Active nasal and/or sinus disease (attributable to EGPA) with a corresponding worsening in at least 1 of the answers on the sinonasal symptom questionnaire (compared with the most recent previous assessment).

Trial Locations

Locations (28)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Fondazione Policlinico Universitario Campus Bio-Medico; 🇮🇹 Roma, Italy

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Osaka Habikino Medical Center; 🇯🇵 Habikino, Osaka, Japan

Complejo Hospitalario de Navarra; 🇪🇸 Pamplona, Spain

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, 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

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

Azienda Provinciale per i Servizi Sanitari Provincia Autonoma Trento; 🇮🇹 Trento, Italy

Azienda Ospedaliera Universitaria Integrata Verona; 🇮🇹 Verona, Italy

Hospital of the University of Occupational and Environmental Health, Japan; 🇯🇵 Kitakyushu, Fukuoka, Japan

NHO Sagamihara National Hospital; 🇯🇵 Sagamihara, Kanagawa, Japan

Tohoku University Hospital; 🇯🇵 Sendai, Miyagi, Japan

Complejo Hospitalario Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, A Coruna, Spain

Addenbrookes Hospital; 🇬🇧 Cambridge, United Kingdom

Royal Berkshire NHS Foundation Trust; 🇬🇧 Reading, United Kingdom

Saitama Medical Center; 🇯🇵 Kawagoe, Saitama, Japan

Juntendo University Hospital; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Kyorin University Hospital; 🇯🇵 Mitaka, Tokyo, Japan