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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06046222
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
Nippon Shinyaku Co., Ltd.
Information provided by (Responsible Party):
NS Pharma, Inc.

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

Condition or disease Intervention/treatment Phase
Eosinophilic Granulomatosis With Polyangiitis Churg-Strauss Syndrome Drug: NS-229 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 20, 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NS-229
Self-administer NS-229 in consecutive 28 weeks.
 Drug: NS-229
Experimental
Placebo Comparator: Placebo
Self-administer matching placebo in consecutive 28 weeks.
 Drug: Placebo
Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of subjects in remission [OGC 4.0] [ Time Frame: 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 :
  1. The proportion of subjects in remission [OGC 7.5] [ Time Frame: 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

  2. Time to first relapse of EGPA [ Time Frame: 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).

  3. Time to first worsening of EGPA [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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 <500 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046222


Contacts
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Contact: NS Pharma, Inc. 1-866-677-4276 trialinfo@nspharma.com

Locations
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United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Japan
Hospital of the University of Occupational and Environmental Health, Japan Recruiting
Kitakyushu, Fukuoka, Japan, 807-8555
NHO Sagamihara National Hospital Recruiting
Sagamihara, Kanagawa, Japan, 252-0392
Tohoku University Hospital Recruiting
Sendai, Miyagi, Japan, 980-8574
Saitama Medical Center Recruiting
Kawagoe, Saitama, Japan, 350-8550
Juntendo University Hospital Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8431
Sponsors and Collaborators
NS Pharma, Inc.
Nippon Shinyaku Co., Ltd.
More Information
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Responsible Party: NS Pharma, Inc.
ClinicalTrials.gov Identifier: NCT06046222    
Other Study ID Numbers: NS229-P2-01
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Submission to the FDA

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Systemic Vasculitis
Churg-Strauss Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
 Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases