Study on the Effectiveness and Safety of NS-229 for Patients with Eosinophilic Granulomatosis with Polyangiitis

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What is this study about?

This clinical trial is focused on studying a condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA). EGPA is a rare disease that causes inflammation of blood vessels, which can lead to damage in various organs. The study is testing a new treatment called NS-229, which is a type of medication known as a Janus kinase (JAK) 1 inhibitor. This medication is being compared to a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to evaluate how effective and safe NS-229 is for treating people with EGPA. Participants in the study will be randomly assigned to receive either the NS-229 tablets or the placebo tablets. The study will last for a period of 28 weeks, during which time the health of the participants will be closely monitored. Researchers will be looking at how many participants experience remission, which means a reduction or disappearance of the symptoms of EGPA, and will also track any side effects or adverse events that occur.

Throughout the study, participants will have regular check-ups to assess their condition and to ensure their safety. The study aims to provide valuable information on whether NS-229 can be a beneficial treatment option for people with Eosinophilic Granulomatosis with Polyangiitis, potentially improving their quality of life by managing the symptoms of this challenging condition.

1 joining the study

Upon joining the study, the participant will be required to provide written informed consent. This involves reading and understanding the study-related materials and agreeing to participate.

Eligibility criteria include being 18 years or older and having a diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA).

2 initial assessment

An initial assessment will be conducted to confirm the diagnosis of EGPA. This may involve reviewing medical history and conducting necessary tests.

The assessment will also determine the current disease activity using a scoring system and the dosage of any ongoing medication like prednisone or prednisolone.

3 randomization and treatment

Participants will be randomly assigned to receive either the study medication, NS-229, or a placebo. The study is double-blind, meaning neither the participant nor the researchers will know which treatment is being administered.

The medication is administered orally in tablet form. The specific dosage and frequency will be determined by the study protocol.

4 treatment period

The treatment period will last for 28 weeks. During this time, participants will continue to take the assigned medication as directed.

Regular follow-up visits will be scheduled to monitor the participant’s health, assess the effectiveness of the treatment, and record any side effects.

5 evaluation of remission

The primary goal is to evaluate the proportion of participants in remission at the end of the 28-week treatment period. Remission is defined by a specific reduction in disease activity and medication dosage.

Secondary evaluations will include the time to first relapse or worsening of the disease.

6 safety monitoring

Throughout the study, any adverse events or side effects will be closely monitored and recorded. This is to ensure the safety of the participants and to identify any potential treatment-related issues.

7 end of study

At the conclusion of the study, a final assessment will be conducted to evaluate the overall health and disease status of the participant.

Participants will be informed of the study results and any relevant findings related to their health.

Who Can Join the Study?

Ability to provide written informed consent before joining the study. This means you should be able to read, understand, and write well enough to fill out study-related documents.
Must be a male or female who is at least 18 years old when signing the informed consent form.
Must have a diagnosis of Eosinophilic Granulomatosis with Polyangiitis (EGPA). This is a condition that involves certain types of white blood cells called eosinophils. You should have a history or current presence of eosinophilia and at least two of the following features:
- A biopsy showing specific types of inflammation involving eosinophils.
- Nerve problems, either affecting one nerve (mono) or multiple nerves (poly).
- Lung issues that are not fixed.
- Problems with the nose or sinuses.
- Heart muscle disease, known as cardiomyopathy.
- Kidney inflammation, known as glomerulonephritis.
- Bleeding in the lungs, known as alveolar hemorrhage.
- Visible skin rash, known as palpable purpura.
- A positive test result for ANCA, which is a type of antibody.
- Asthma.
Must have a BVAS score of 3 or more at the screening visit, which looks at disease activity over the past 28 days, and be taking a dose of prednisone or prednisolone of at least 7.5 mg per day. Alternatively, must have had disease activity within 60 days of the screening visit that is similar to a BVAS score of 3 or more and be taking a dose of prednisone or prednisolone of at least 20 mg per day at the time of screening.
Female participants who can have children must agree to use highly effective birth control methods from the time they give informed consent until 90 days after the last dose of the study treatment. Male participants with partners who are pregnant or can become pregnant must also agree to use reliable birth control from the time of informed consent until 90 days after the last dose of the study treatment.

Who Cannot Join the Study?

Patients who have a different condition than eosinophilic granulomatosis with polyangiitis (EGPA) cannot participate. EGPA is a rare disease that causes inflammation of blood vessels.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not part of the specified clinical trial group cannot participate. This means the study is looking for specific types of participants.
Patients who are not male or female cannot participate. The study is open to both men and women.
Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
mjktmb Kwqulxnx gxipg	Ostfildern	Germany
Isgce Owakpwey Ardsqhwqar Spi Lugp	Milan	Italy

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.04.2024
Germany	Recruiting	01.04.2024
Italy	Recruiting	01.04.2024
Spain	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Methyl-(1-{[6-{[(1S)-1-Cyclopropylethyl]Amino}-2-(Pyrazolo[5,1-B][1,3]Thiazol-7-Yl)-Pyrimidin-4-Yl]Carbonyl}Piperidin-4-Yl)Carbamate-Mono(4-Methylbenzenesulfonate) Monohydrate

NS-229 is a medication being studied for its effectiveness and safety in treating a condition called Eosinophilic Granulomatosis with Polyangiitis (EGPA). This condition is a rare disease that causes inflammation of blood vessels, which can lead to damage in various organs. The trial aims to see how well NS-229 can help patients achieve remission, meaning a reduction or disappearance of the symptoms, and to monitor any side effects that may occur during the treatment.

Investigated diseases:

Eosinophilic granulomatosis with polyangiitis

Eosinophilic Granulomatosis with Polyangiitis (EGPA) – This is a rare autoimmune disease characterized by inflammation of small to medium-sized blood vessels, which can affect various organs. It often begins with symptoms like asthma and allergic rhinitis, progressing to more severe manifestations such as skin rashes, nerve damage, and kidney issues. The disease is marked by an increase in eosinophils, a type of white blood cell, which can lead to tissue damage. As the condition advances, it may cause complications in the respiratory system, heart, and gastrointestinal tract. The progression of EGPA can vary significantly among individuals, with periods of remission and flare-ups.

Trial ID:

2023-504245-32-00

Protocol code:

NS229-P2-01

NCT ID:

NCT06046222

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of NS-229 for Patients with Eosinophilic Granulomatosis with Polyangiitis

What is this study about?

Who Can Join the Study?

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