Potential New Treatment for EGPA to Reduce Need for Oral Steroids
Trial Objectives
Eosinophilic Granulomatosis with Polyangiitis, or EGPA, is a rare autoimmune condition that affects small blood vessels throughout the body. Current treatments mostly rely on oral corticosteroids to reduce inflammatory symptoms, sometimes accompanied by medication that suppresses the immune response. Researchers in this clinical trial want to determine if a new investigational treatment called NS-229 can help people with EGPA experience remission of their symptoms or reduce the need for oral steroids.Volunteers will be randomly assigned to receive either NS-229 or a placebo (a medication containing no active ingredient) in an oral tablet taken daily for 28 weeks. At study visits, volunteers will receive physical examinations, breathing tests and electrocardiograms (EKGs) as well as collection of blood and urine samples. They will also receive electronic questionnaires to complete over the course of the study. Qualified participants have a 2 in 3 chance of receiving active medication and a 1 in 3 chance of receiving placebo.
Who Can Participate
Participants must have a documented diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA) based on a history of blood testing and other features. They also must have active symptoms affecting other organs despite taking oral corticosteroid treatments.
Age: 18+ Gender: Any
Estimated Time Commitment
11 visits over 36 weeks (9 months). The first treatment visit will last up to 8 hours, and all other study visits will take approximately 3 hours.
Payment & Reimbursement
Payment: Provided
Travel Reimbursement: Not Available
Trial Location
National Jewish Main Campus, Denver, CO
Trial Sponsors
NS Pharma, Inc.
Principal Investigators
Michael E. Wechsler, MD, MMSc
Co-Investigators
Vamsi P. Guntur, MD, MSc