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

Description

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

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Study Overview

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Study Details

Study overview

This study will enroll male and female subjects who are 18 years of age or older 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

Condition
Eosinophilic Granulomatosis With Polyangiitis
Intervention / Treatment

-

Contacts and Locations

Denver

National Jewish Health, Denver, Colorado, United States, 80206

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NS Pharma, Inc.,

Study Record Dates

2026-07