RecruitingPhase IIIInterventional

A Study of Icotrokinra in participants with moderately to severely active Crohn's disease

This research study is looking into a new medicine, icotrokinra, for people aged 18 and over who have moderate to severe Crohn's disease. Crohn's is a condition that causes inflammation in the digestive system. Even though there are already treatments, some people don't respond to them or can't handle the side effects. Icotrokinra aims to reduce inflammation by blocking a specific protein in the body. The study will compare icotrokinra to a placebo (a treatment with no active medicine) to see how well it works and if it's safe. Taking part means regular check-ups and may involve using the new medicine or the placebo for an extended period, potentially around 5 years. The aim is to find better treatment options for Crohn's disease.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International N.V.

Enrolment target

1,092

Start

01 Nov 2025

Estimated completion

01 Aug 2027

Moderate to Severe Crohn's disease, Plaque psoriasis

What is this study about?

Crohn's disease is a condition where your digestive system becomes inflamed and can develop sores. While there are existing treatments, they don't always work for everyone, or some people might experience difficult side effects. This means there's a real need to find new and more effective ways to help people living with Crohn's.

This study is testing a new medicine called icotrokinra (also known as JNJ-77242113). It works by targeting a specific protein in the body that plays a role in causing inflammation. By blocking this protein, researchers hope to reduce the inflammation seen in Crohn's disease. The main goal of this study is to see how well icotrokinra works compared to a 'placebo', which is a treatment that looks like the real medicine but contains no active ingredients.

This is a 'Phase 3' study, which means the medicine has already been tested in smaller groups of people, and now researchers want to confirm its effectiveness and safety in a larger group. The results from this study will help decide if icotrokinra could become a new approved treatment option for Crohn's disease.

Key takeaways

Tests a new medicine (icotrokinra) for moderate to severe Crohn's disease.
Compares icotrokinra against a placebo (dummy treatment).
Participation involves regular check-ups and taking daily study medicine for up to 5 years.
May help find a new treatment for Crohn's disease.
Potential for benefits but also risks and side effects, as with any new medicine.
No cost to participate; travel expenses will be reimbursed.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with moderate to severe Crohn's disease for at least 12 weeks. Your Crohn's should still be active, based on specific medical scores and a recent examination of your bowel.

It's important that your previous Crohn's treatments haven't worked well enough, or you couldn't tolerate them. If you are a woman who could become pregnant, you'll need to have negative pregnancy tests and agree to further tests during the study.

Some things might prevent you from joining. For example, if you have certain complications from Crohn's like blockages that might need surgery, or if you've recently had major surgery on your bowel. People with a stoma or ostomy are also unable to join. If you have active fistulas, you might still be able to join if surgery isn't needed for them.

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.

Are you 18 years or older?
Do you have a diagnosis of moderate to severe Crohn's disease?
Are your current Crohn's treatments not working well enough, or do you have side effects?
Have you *not* had major bowel surgery recently (within the last 3 months)?
Are you able to attend regular study appointments and follow instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 5 years. It starts with a ‘screening period’ of up to 6 weeks to make sure you’re suitable. After that, there are different phases, including ‘induction’ (the initial treatment period) and ‘maintenance’ (a longer-term treatment period), followed by a long-term extension. You'll be taking daily doses of either icotrokinra or a placebo. The specific dose you get might change during the study and depends on how you respond. If you don’t respond well initially, your treatment might be adjusted.

Throughout the study, you'll have regular visits and assessments. These include physical exams, checking your vital signs (like blood pressure), blood and urine tests, heart checks (ECG), and specific tests for Crohn's disease activity, including a telescope examination of your bowel (video ileocolonoscopy). We'll also check for any side effects and conditions like tuberculosis. After your last dose of the study medicine, there will be a follow-up period of up to 4 weeks to monitor your health. There are no costs for you to be in the study, and you will get help with travel expenses.

Potential risks and benefits

There’s no guarantee that you will personally benefit from taking part in this study, as icotrokinra is still being investigated. You might receive a placebo and not the active medicine. However, if icotrokinra works, it could help improve your Crohn's disease, and your participation will definitely help other people with Crohn’s in the future by increasing our understanding of new treatments. Possible risks include experiencing side effects from the medicine or the procedures, which could range from mild to severe, and in rare cases, life-threatening. These can include allergic reactions, infections, and issues related to the bowel examinations like bleeding or discomfort. The study team will monitor you closely for any side effects, and you can withdraw from the study at any time if you change your mind.

Locations (9)

St George's University Hospitals NHS Foundation Trust
City only
London, England
Fairfield General Hospital
Approximate
Bury, England
Guys Hospital
City only
London, England
Addenbrookes
Approximate
Cambridge, England
Glasgow Royal Infirmary
Approximate
Glasgow, Scotland
Whiston Hospital
City only
Prescot, England
Whipps Cross University Hospital
Approximate
London, England
Queen Elizabeth Hospital
Approximate
Birmingham, England
Stepping Hill Hospital
Approximate
Stockport, England

Common questions

What is Crohn's disease?

Crohn's disease is a long-lasting condition that causes inflammation and sores in your digestive system, which can lead to tummy pain, diarrhoea, and weight loss.

What is icotrokinra?

Icotrokinra is a new medicine being tested. It works by blocking a specific protein in the body that helps cause inflammation, aiming to reduce the symptoms of Crohn's disease.

What is a placebo?

A placebo is a dummy treatment that looks like the real medicine but doesn't contain any active ingredients. It helps researchers see if the new medicine is truly effective compared to doing nothing.

How long will the study last?

The study is expected to last for about 5 years, including screening, treatment periods, and follow-up.

Will I have to pay for anything?

No, there are no costs for you to participate. The study sponsor will cover the cost of the medicine and tests, and you'll receive reimbursement for travel and parking.

How to find out more

. Janssen UK Registry

JanssenUKRegistryQueries@its.jnj.com - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.