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Study on Tadekinig Alfa for Patients with NLRC4 Mutation and XIAP Deficiency

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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 two rare genetic conditions known as NLRC4 mutation and XIAP deficiency. These are types of autoinflammatory diseases, which are conditions where the immune system mistakenly attacks the body, causing inflammation. The treatment being tested in this study is called Tadekinig alfa, also known by its code name rhIL-18BP. This medication is given as a solution for injection under the skin.

The purpose of this study is to monitor the long-term safety and tolerability of Tadekinig alfa in patients who have these specific genetic conditions. Patients participating in this study have previously been involved in an earlier clinical trial. This study is an open-label extension, meaning that all participants will receive the actual medication, and there is no placebo group. The study will observe how patients respond to the treatment over time, focusing on any side effects or adverse reactions they may experience.

Participants will receive regular injections of Tadekinig alfa and will be monitored by healthcare professionals throughout the study. The study aims to ensure that the treatment is safe and well-tolerated by patients with NLRC4 mutation and XIAP deficiency. The study will continue for a set period, during which patients will have regular check-ups to assess their health and any changes in their condition.

The research process

The trial runs in 4 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, ensure that you have previously participated in the initial clinical trial related to NLRC4 or XIAP conditions. This is a requirement for participation in this extension study.

    If you are a woman of childbearing potential, a negative urine pregnancy test is required at all visits. If the test is positive, a blood test will be conducted to confirm the result.

  2. Step 2

    Treatment administration

    You will receive the medication tadekinig alfa as a solution for injection. This medication is administered through a subcutaneous injection, which means it is injected under the skin.

    The frequency and dosage of the medication will be determined by the study team based on your specific condition and response to treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular monitoring will be conducted to evaluate the safety and tolerability of the treatment. This includes checking for any adverse events or abnormal laboratory results.

    Local tolerability, which refers to how well the injection site handles the medication, will also be assessed. Additionally, evaluations will be made to understand how your body processes the medication.

  4. Step 4

    End of study

    The study is expected to continue until April 30, 2024. At the end of the study, a final assessment will be conducted to review your overall health and response to the treatment.

    If you are a woman of childbearing potential, it is recommended to continue using effective birth control methods for four weeks after the end of the treatment.

Who can join the trial?

8 criteria

  • Patients must have participated in the previous clinical trial called NLRC4/XIAP.2016.001.
  • Patients should have completed the first 18-week phase of the previous trial, even if they were not eligible for the next phase due to flare symptoms.
  • Patients who completed both the first 18-week phase and the next phase of the previous trial can participate.
  • Patients who had to stop the previous trial due to treatment failure and needed additional treatment must wait at least 4 weeks before joining this study.
  • The time between finishing the previous trial and starting this study should not be more than 3 months.
  • Women of childbearing potential (women who can become pregnant) must have a negative urine pregnancy test at all visits. If the test is positive, a blood test will be done to confirm.
  • Women must agree to use highly effective birth control methods during the study and for 1 month after the treatment ends. These methods include hormonal contraception, intrauterine devices (IUD), or having a partner who has had a vasectomy.
  • If a woman's menstrual period is delayed by more than one month, it is strongly recommended to confirm that she is not pregnant. This is also important for women with irregular menstrual cycles.

Who cannot join the trial?

8 criteria

  • Patients who have not participated in the previous clinical trial related to NLRC4 or XIAP conditions.
  • Patients who do not have the specific genetic mutations related to NLRC4 or XIAP.
  • Patients who are not suffering from the specific pediatric monogenic autoinflammatory diseases being studied.
  • Patients who are not within the required age range for the study.
  • Patients who have any other medical conditions that might interfere with the study.
  • Patients who are unable to comply with the study procedures or follow-up requirements.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them.
  • Patients who are currently participating in another clinical trial that might affect the results of this study.
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Investigated drugs

Tadekinig alfa is a medication used in this clinical trial to help manage certain rare genetic conditions that cause inflammation in the body. These conditions are known as autoinflammatory diseases, and they can lead to symptoms like fever, rash, and joint pain. Tadekinig alfa works by blocking a specific protein in the body called IL-18, which is involved in causing inflammation. By reducing the activity of this protein, the medication aims to decrease the symptoms and improve the quality of life for patients with these conditions. This trial is focused on understanding how safe and tolerable Tadekinig alfa is for long-term use in patients with specific genetic mutations that lead to these diseases.

What is already known about the treatment

Tadekinig alfa – Tadekinig alfa is administered as an injection and is currently being studied in clinical trials to assess its safety and tolerability for long-term use. It is primarily used for treating specific genetic inflammatory conditions known as NLRC4 mutation and XIAP deficiency, which are rare disorders causing excessive inflammation. At the molecular level, Tadekinig alfa works by blocking a protein called IL-18, which plays a role in the inflammatory process, helping to reduce inflammation in the body. It is classified as an interleukin inhibitor, a type of medication that targets specific proteins involved in the immune response.

Investigated diseases

  • NLRC4 Mutation

    NLRC4 mutation is a genetic condition that affects the immune system, leading to excessive inflammation. This mutation causes the body's defense system to become overactive, resulting in recurrent episodes of fever and inflammation in various parts of the body. The inflammation can affect the skin, joints, and internal organs, causing pain and discomfort. Over time, the persistent inflammation can lead to tissue damage. The condition is typically identified in childhood and can vary in severity among individuals. It is a rare condition, often requiring genetic testing for confirmation.

  • XIAP Deficiency

    XIAP deficiency is a genetic disorder that impairs the immune system's ability to regulate inflammation and cell death. This deficiency can lead to chronic inflammation, recurrent infections, and an increased risk of developing inflammatory bowel disease. The condition is caused by mutations in the XIAP gene, which plays a crucial role in controlling immune responses. Symptoms often begin in childhood and can include fever, diarrhea, and abdominal pain. The severity of the condition can vary, with some individuals experiencing more severe symptoms than others. It is a rare condition that is often diagnosed through genetic testing.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504534-21-00Protocol codeOLE-NLRC4/XIAPEstimated enrolment11 patientsSponsorAB2 Bio S.A.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).