Active not recruitingPHASE2INTERVENTIONAL

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

This research study is testing a new medication called NS-229 for adults aged 18 and over who have Eosinophilic Granulomatosis with Polyangiitis (EGPA), also known as Churg-Strauss Syndrome. We want to find out if NS-229 helps reduce the symptoms of EGPA and is safe to use. Half of the participants will receive NS-229 and the other half will receive a dummy treatment (placebo), alongside their existing steroid medication, which will be gradually reduced during the study. Some participants might also be taking other medications like Mepolizumab or Benralizumab. The study will last 28 weeks, and we'll be checking to see if people experience fewer symptoms and can lower their steroid dose.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

NS Pharma, Inc.

Enrolment target

Start

20 Dec 2023

Estimated completion

01 Dec 2026

Eosinophilic Granulomatosis With Polyangiitis Churg-Strauss Syndrome

What is this study about?

This study is about a health condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA), also known as Churg-Strauss Syndrome. EGPA is a rare condition that causes inflammation in blood vessels and affects different parts of the body. We are looking for people with this condition to help us test a new medication called NS-229.

The main aim of this study is to see how well NS-229 works and if it's safe. We'll be comparing it to a 'placebo', which is a dummy treatment that looks like the study drug but doesn't contain any active medication. This helps us understand if any improvements are genuinely due to NS-229 or if they might happen anyway. All participants will continue to take their usual steroid medication, and the study will look at whether they can safely reduce their steroid dose over a 28-week period, which is often a goal for people with EGPA.

Taking part in this study could potentially help us find a new way to manage EGPA. By understanding how NS-229 affects the condition, we hope to improve treatment options for people living with EGPA in the future. Your participation would be a valuable contribution to medical research.

Key takeaways

Tests a new medication (NS-229) for EGPA.
Compares NS-229 to a dummy treatment (placebo).
Aims to reduce steroid dose over 28 weeks.
Open to adults 18+ with diagnosed EGPA.
Helps advance understanding and treatment of EGPA.

Who may be eligible?

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.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of EGPA (Churg-Strauss Syndrome)?
Are you currently taking at least 7.5mg of steroids daily?
Are you able to use effective birth control if you could become pregnant?
Do you have any serious health problems like heart, kidney, or liver disease that is not controlled, or active infections?
Have you had certain types of cancer in the last 5 years?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

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.

Potential risks and benefits

Taking part in this study could potentially lead to improvements in your EGPA symptoms, and you might be able to reduce your steroid medication, which has its own benefits. However, as with any medication, there's a chance you might experience side effects from NS-229, or you might not see any improvement in your condition. The dummy treatment (placebo) also means there’s a 50/50 chance you won't be receiving the active drug. The study team will monitor you closely for any health changes. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (34)

National Jewish Health
Denver, United States
Mayo Clinic
Rochester, United States
Cleveland Clinic
Cleveland, United States
The Ohio State University Wexner Medical Center
Columbus, United States
University of Pennsylvania
Philadelphia, United States
Medical University of South Carolina
Charleston, United States
Vanderbilt University Medical Center
Nashville, United States
University of Alberta
Edmonton, Canada
St Joseph's Healthcare Hamilton
Hamilton, Canada
University of Toronto
Toronto, Canada
CHU Nice
Nice, France
Hopital Cochin
Paris, France

+22 more sites — see the official record for the full list.

Common questions

What is Eosinophilic Granulomatosis with Polyangiitis (EGPA)?

EGPA, also known as Churg-Strauss Syndrome, is a rare condition that causes inflammation in blood vessels, which can affect many organs in the body.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the study drug but contains no active medication. It helps us see if the new drug is truly working.

Will I still take my regular medication?

Yes, you will continue to take your steroid medication, which will be gradually reduced during the study. You may also continue other specific EGPA medications if your doctor agrees.

How long will the study last?

The active treatment part of the study will last for 28 weeks (about 7 months), with some follow-up after that.

Is this new medication approved for general use?

No, NS-229 is an investigational drug, which means it is still being studied and is not yet available for general use. This is a study to see if it should become available.