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

Launched by NS PHARMA, INC. · Sep 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called NS-229 to see how well it works and how safe it is for people with Eosinophilic Granulomatosis With Polyangiitis (EGPA), also known as Churg-Strauss Syndrome. The study is open to both men and women who are 18 years or older and have been diagnosed with EGPA. To participate, individuals must be currently taking a specific dose of another medication (at least 7.5 mg per day) and have certain symptoms related to EGPA.

Participants in the trial will receive either the new medication or a placebo (a harmless pill with no active ingredients) to help researchers compare the effects. It's important to note that some people may not be eligible for the study, such as those with certain serious health conditions, recent cancer history, or those who are pregnant. If you or a loved one are considering this trial, you can expect close monitoring and support throughout the study, as well as the chance to help advance research for this condition.

Gender

ALL

Eligibility 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.
• • Subjects receive background OGC dose of ≥7.5 mg/day with or without stable treatment with Mepolizumab/Benralizumab.
• • 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 \<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.