RECRUITING

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

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Conditions

Eosinophilic Granulomatosis With PolyangiitisChurg-Strauss Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-12-20
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06046222

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide written informed consent prior to participation in the study.
  2. * Male or female subjects aged ≥18 years at the time the informed consent form is signed.
  3. * 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.
  4. * Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatment with mepolizumab.
  5. * Use of adequate contraception.
  6. * Other inclusion criteria may apply.
  1. * Current diagnosis of either granulomatosis with polyangiitis or microscopic polyangiitis
  2. * Imminently life-threatening EGPA at the time of screening.
  3. * History or presence of any form of cancer within 5 years prior to screening.
  4. * Serious liver, renal, blood, or psychiatric disease
  5. * Severe or clinically significant cardiovascular disease uncontrolled with standard treatment
  6. * Active systemic infections (including TB, pneumonia, Pneumocystis pneumonia, sepsis, and opportunistic infections)
  7. * Parasitic infection: Subjects with a known parasitic infestation within 6 months prior to screening.
  8. * HIV positive status
  9. * Active hepatitis due to hepatitis B virus or hepatitis C virus
  10. * Known history or presence of venous thromboembolism/venous thrombotic events (deep vein thrombosis and/or pulmonary embolus)
  11. * laboratory parameter exclusions:
  12. 1. Estimated glomerular filtration rate of \<30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equations
  13. 2. WBC count \<4 × 109/L
  14. 3. Absolute lymphocyte count \<500 cells/mm3
  15. 4. Absolute neutrophil count \<1000 cells/mm3
  16. 5. Platelet count \<120,000/mm3
  17. 6. Hemoglobin \<8 g/dL (\<80 g/L)
  18. * Subjects who are pregnant, breastfeeding, or planning to become pregnant during the time of study participation
  19. * History of clinically significant drug or alcohol abuse within the last 6 months
  20. * Other exclusion criteria may apply.

Contacts and Locations

Study Contact

NS Pharma, Inc.
CONTACT
1-866-677-4276
trialinfo@nspharma.com

Study Locations (Sites)

National Jewish Health
Denver, Colorado, 80206
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: NS Pharma, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20
Study Completion Date2026-07

Study Record Updates

Study Start Date2023-12-20
Study Completion Date2026-07

Terms related to this study

Additional Relevant MeSH Terms

  • Eosinophilic Granulomatosis With Polyangiitis
  • Churg-Strauss Syndrome