AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multicenter, Open Label, Basket, Long-term Extension Study of Icotrokinra in Pediatric Clinical Study Participants

This clinical trial is testing a medicine called icotrokinra (also known as JNJ-77242113) in children and teenagers with immune system conditions. The immune system normally protects the body from illness, but sometimes it becomes overactive and causes unwanted inflammation and swelling. Icotrokinra is designed to help calm this reaction. This is a 'long-term extension' study. That means it is open to young people who have already taken part in an earlier trial testing this same medicine. Because this is an 'open-label' study, there is no dummy pill (placebo). Every young person who takes part will receive the real medicine. The main goal of the trial is to see how safe the medicine is when taken over a longer period and how well it continues to work as young people grow. Doctors will check participants regularly through health exams and routine blood tests.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Janssen Cilag International

Enrolment target

Start

15 Oct 2026

Immune System Disorders

What is this study about?

Our immune system acts like a shield, defending our bodies against bugs and infections. However, in people with immune conditions, this defence system becomes confused and overactive. It begins attacking healthy parts of the body, which can lead to ongoing swelling, irritation, and discomfort. Researchers are studying a new oral medicine called icotrokinra to see if it can help bring this immune response back into balance.

When a new medicine is first tested, early studies usually only last a few months. While this gives doctors useful initial clues, they also need to know whether the medicine remains safe and helpful when taken for a much longer time. This trial is called a 'long-term extension study'. It gives young people who have already completed an earlier trial with icotrokinra the chance to carry on taking the medicine.

In this study, there is no dummy drug (known as a placebo). Every young person enrolled will receive icotrokinra. Specialists will keep a close eye on each participant's health, tracking how well their symptoms stay under control and watching carefully for any side effects as they continue their everyday lives and continue to grow.

Key takeaways

This is a long-term safety study of icotrokinra for children and young people.
Only participants who have completed an earlier trial with this medicine can join.
All children in this trial receive the real medicine; there is no dummy pill (placebo).
Regular hospital appointments and blood tests are used to protect your child's safety.
Participation is completely voluntary and you can stop at any time.

Who may be eligible?

This study is only for children and young people who have already taken part in an earlier clinical trial testing icotrokinra for an immune condition. If your child was not enrolled in one of these prior studies, they will not be able to join this particular trial.

To take part, the young person must be well enough to continue treatment safely, as decided by the study doctors. They and their parent or guardian must also be happy to follow the study schedule, which includes taking the medicine regularly and attending hospital appointments.

Children who experienced serious side effects in the previous study, or who currently have serious infections such as tuberculosis (TB), will not be able to join. The study team will carefully review your child's medical history before they are accepted onto the extension study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

My child has already completed an earlier trial using icotrokinra.
My child has an immune condition being monitored by the trial team.
My child can swallow oral medicine as instructed.
We are able to attend regular check-ups and hospital appointments.
My child does not have an active serious infection, such as tuberculosis.

Answer every question to see your result.

What does participation involve?

If your child joins, they will receive the study medicine, icotrokinra, which is taken by mouth as directed by the clinic team. You will need to bring your child to regular clinic visits at the hospital. During these visits, doctors and nurses will check their height, weight, blood pressure, and overall health. They will also take routine blood and urine samples to check how the body and liver are responding to the medicine. Parents may be asked to keep a simple diary of when the medicine is taken and any symptoms noticed. The study is designed to run for a long period, often several years, followed by a final safety check-up after the medicine is stopped.

Potential risks and benefits

The main benefit of taking part is the opportunity to continue receiving a treatment that may help manage your child's immune condition without any chance of receiving a dummy pill. However, all medicines have possible risks. Icotrokinra can cause side effects, such as tummy upsets, an increased chance of catching everyday infections, or temporary changes in liver function. The trial team will monitor your child very closely with regular tests to detect any issues early. Taking part is entirely voluntary, and you can withdraw your child from the study at any time without giving a reason and without your child's standard NHS care being affected.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Spain
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Unverified
Germany
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Unverified
Poland

Common questions

What is an open-label extension study?

It is a follow-up trial where everyone receives the real medicine and no dummy pill (placebo) is used, allowing doctors to study its effects over a longer period.

Will my child receive a placebo?

No. In this study, every participant receives the active medicine, icotrokinra.

Can we leave the study at any point?

Yes. You and your child can choose to stop taking part at any time. This will not change the standard medical care your child receives.

How is the medicine taken?

Icotrokinra is an oral medicine, meaning it is taken by mouth as tablets or capsules according to the study doctor's instructions.

Does taking part cost anything?

No. The trial medicine, tests, and doctor visits are provided at no cost, and travel expenses to hospital appointments are usually reimbursed.