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Long-Term Safety Study of JNJ-77242113 in Children with Immune System Disorders

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study involves children with Immune System Disorders. These are conditions where the body’s defense system does not work properly, leading to frequent infections or other problems. Participants will receive the experimental medicine icotrokinra (code name JNJ-77242113), taken as a small film‑coated tablet by mouth.

The purpose of the study is to evaluate the long‑term safety of the medicine in this patient group.

During the trial, children will take the tablet each day for an extended period while the research team checks them regularly. Visits will include simple physical exams, blood tests, and questions about any new symptoms. The team will record any AE (adverse event, meaning a side effect), any SAE (serious adverse event, meaning a side effect that is severe or requires medical attention), and will pay special attention to signs of active TB (tuberculosis, an infection of the lungs), cancer, or possible liver injury as indicated by Hy’s Law. Laboratory tests will look at blood cells and chemistry to spot any problems early.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Consent

    After joining the study, you will sign an informed consent form that explains the purpose of the trial and your rights as a participant.

    You will provide basic personal and health information that the study team will use to determine eligibility.

  2. Step 2

    Baseline Assessments

    The study team will perform a physical examination and review your medical history related to immune system disorders.

    Blood samples will be taken for laboratory tests that check hematology (blood cells) and chemistry (organ function).

  3. Step 3

    Start of Study Medication

    You will begin taking icotrokinra in the form of a film‑coated tablet that is taken by mouth.

    The specific dose, how often you should take the tablet, and the exact length of treatment are not detailed in the provided information, but the medication will be taken for the duration of the long‑term extension study.

  4. Step 4

    Ongoing Medication Administration

    You will continue to take the tablet exactly as instructed, keeping a record of each dose you take.

    If any dose is missed, you will follow the guidance given by the study team on how to proceed.

  5. Step 5

    Scheduled Clinic Visits

    You will attend regular clinic visits throughout the study period, which runs from January 15 2027 to June 20 2028.

    During each visit, the study staff will check your health, review any side effects, and ensure the medication is being taken correctly.

  6. Step 6

    Laboratory Monitoring

    At each clinic visit, blood will be drawn to monitor safety indicators such as blood cell counts and organ function.

    These laboratory results help the study team detect any potential problems early.

  7. Step 7

    Reporting Adverse Events

    You are asked to inform the study team promptly about any new or worsening symptoms, including signs of infection, unusual pain, or other health changes.

    Serious adverse events (SAEs) and events that could lead to stopping the medication will be recorded and evaluated.

  8. Step 8

    Study Completion

    At the end of the study period (June 20 2028), you will undergo a final health assessment and laboratory testing.

    The study medication will be discontinued, and you will receive a summary of the study findings related to your participation.

Who can join the trial?

5 criteria

  • You must be younger than 18 years old when you receive the first dose of the study medicine.
  • You must have already finished the dosing schedule of the earlier icotrokinra trial.
  • Your doctor must think that you are still getting a benefit from continuing icotrokinra treatment.
  • If you are female, you must either not be able to have children (not of childbearing potential) or, if you could have children (of childbearing potential), you must not be sexually active, or you must use a very reliable birth‑control method (highly effective method of contraception—fails less than 1 % per year when used correctly) and agree to keep using it during the study and for 90 days after the last dose.
  • If you are male, you must agree to the following for the time you are in the study and for at least 90 days after the last dose: (a) if you have sex with a woman who could become pregnant, you must use a barrier form of birth control (barrier method of contraception) such as a condom with sperm‑killing gel; (b) if you have sex with a woman who is already pregnant, you must use a condom; and (c) you must not donate sperm (sperm donation) for 90 days after the last dose.

Who cannot join the trial?

4 criteria

  • Children who are younger than 18 years old and live in a country where this medicine is already officially approved for children and the cost is reimbursed (paid for by health insurance or the government) cannot join the study.
  • Anyone who is pregnant, nursing (breastfeeding), planning to become pregnant, or a man planning to become a father is not allowed to participate.
  • People who work for the study’s main doctor (investigator) or the trial site, or any close family members of those employees, cannot be enrolled.
  • If the doctor believes that a participant’s other health problem would make the study unsafe, could hurt the participant’s well‑being, or would make the study results unclear (confound the assessments), that person cannot take part.
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Investigated drugs

JNJ-77242113 is an experimental medication that is being tested to see if it can be used safely in children over a long period of time. In the study, the drug is taken by mouth as a film‑coated tablet. Participants receive the medication and are followed for many months so researchers can watch for any side effects, health changes, or other safety concerns. The main purpose of the trial is to gather detailed information about how safe the drug is for pediatric patients when used for an extended time.

What is already known about the treatment

Icotrokinra - Icotrokinra is taken as a film‑coated tablet that is swallowed by mouth. It is still an investigational drug, currently being studied in Phase 3 trials for children with immune system disorders. The medicine works by blocking a protein called interleukin‑1 that can cause inflammation, helping to calm an over‑active immune response. It belongs to the class of interleukin‑1 receptor antagonists.

Investigated diseases

Immune System Disorders - These are conditions in which the body’s defense system behaves abnormally, either attacking its own tissues or failing to protect against infections. The abnormal activity can cause chronic inflammation, tissue damage, and loss of normal organ function. Symptoms often appear slowly and may become more noticeable over time as the immune response continues unchecked. As the disorder progresses, affected areas can become increasingly impaired, leading to broader health impacts. The course of the disease varies, but it typically follows a pattern of gradual worsening without appropriate management.
Trial detailsLast updated 17 Oct 2026
Age0-17PhasePhase IIITrial ID2026-526290-41-00Protocol code77242113ISD3001Estimated enrolment13 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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