Studio di Efficacia e Sicurezza di NS-229 Versus Placebo in Pazienti con Granulomatosi Eosinofila con Poliangioite

To join this study, you need to be an adult aged 18 or older and have a diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA). You must also be taking at least 7.5 mg of steroids each day and, if you're already on medications like Mepolizumab or Benralizumab, your treatment should be stable. Both men and women can take part, and if you are able to become pregnant, you'll need to use reliable birth control during the study.

There are certain reasons why you might not be able to join. For example, if your EGPA is currently very severe and life-threatening, or if you have had certain serious health issues like some types of cancer in the last five years, severe heart, kidney, liver, or blood problems, or uncontrolled mental health conditions. If you have serious active infections like TB or HIV, or active hepatitis B or C, you also can't take part. We also check your blood test results to make sure your blood cell counts and kidney function are within healthy ranges. You also cannot be pregnant, breastfeeding, or planning to become pregnant during the study.

If you decide to take part, you'll be assigned by chance to either receive the study medication (NS-229) or a dummy treatment (placebo) – neither you nor your study doctor will know which one you are getting. You'll continue to take your regular steroid medication, and over the 28 weeks of the study, your steroid dose will be carefully and gradually reduced. You might also be taking other specific EGPA medications if you are already on them. You will attend regular clinic visits where the study team will monitor your health, check for any side effects, and carry out various assessments and blood tests. There will be follow-up calls or visits after the 28-week treatment period to ensure your well-being. The total duration of your active involvement in the study will be about 28 weeks, plus any follow-up.