Study to Investigate the Efficacy and Safety of | Clinical Research Studies Listing

Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of EGPA

Recruiting

18-90 years

All

Phase 2

5 participants needed

1 Location

Brief description of study

The main purpose of this study is to learn how well the investigational drug NS-229 works and how safe NS-229 is compared with placebo. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA) to treat EGPA. Participants could be in the study for about 9 months and come to Penn for at least 11 study visits over this period.

Detailed description of study

Each visit will last about 3-4 hours except for Day 1 which is longer. During some or all of the visits, participants have physical exams, ECGs (electrocardiogram), lung function tests, blood and urine collection, and complete questionnaires and keep a daily diary.

Participants are randomly assigned into 1 of 2 groups. One group receives NS-229 and the other group receives placebo. Each person has about 67% (2 in 3) chance of receiving NS-229 and about 33% (1 in 3) chance of receiving placebo. Placebo means a substance that looks like NS-229, but it does not have any active drug in it. The study drug is taken by mouth. This is a double-blind study, which means neither participants nor the study team know which group a participant is in.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Eosinophilic Granulomatosis With Polyangiitis; EGPA
Age: Between 18 Years - 90 Years
Gender: All

There are many factors that determine eligibility. Some requirements include:

· Adults with EGPA diagnosis and a history of relapsing or refractory disease

· On a stable daily dose of 7.5 mg or more of prednisone

Updated on 01 Aug 2024. Study ID: 854964

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