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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

5 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

NS-229 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating eosinophilic granulomatosis with polyangiitis (EGPA). It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for NS-229 is to help patients achieve remission from EGPA, a rare inflammatory condition. At the molecular level, NS-229 works by modulating the immune response to reduce inflammation and prevent damage to blood vessels. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504245-32-00Protocol codeNS229-P2-01Estimated enrolment45 patientsSponsorNs Pharma Inc.

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