RecruitingPhase IIIInterventional

Study evaluating the efficacy of icotrokinra in ulcerative colitis

Researchers are looking for adults and teenagers (aged 12 and over) with moderate to severe ulcerative colitis (UC) to take part in a study testing a new medicine called icotrokinra. UC is a long-term condition where the large bowel becomes inflamed and develops small sores. While there are treatments, not everyone finds them effective or easy to tolerate. Icotrokinra aims to reduce inflammation by blocking a specific protein in the body. The study will compare icotrokinra to a dummy medicine (placebo) to see if it can help calm UC symptoms and keep them under control. It will also check for any side effects.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International N.V.

Enrolment target

882

Start

01 Oct 2025

Estimated completion

08 Dec 2026

Ulcerative colitis

What is this study about?

Ulcerative colitis (UC) is a long-term condition that affects your large bowel (colon). It causes the lining of your bowel to become inflamed and develop tiny open sores. This can lead to symptoms like tummy pain, diarrhoea, and blood in your poo. Even though there are treatments available, they don't work for everyone, or some people find the side effects too difficult to manage. This means there's a need for new and better medicines for UC.

This study is looking at a new medicine called icotrokinra. Our bodies have proteins that can cause inflammation, and one of these is called interleukin-23 (IL-23). Icotrokinra works by stopping IL-23 from connecting to its partner protein, which helps to reduce the inflammation that causes many of the uncomfortable UC symptoms. The main goal of this study is to find out how well icotrokinra can help settle down UC symptoms (this is called 'inducing remission') and then keep the disease under control (this is called 'maintaining remission').

We'll be studying both adults and teenagers (aged 12 and over) who have UC that is currently quite active, meaning they are experiencing noticeable symptoms. The study will compare icotrokinra to a dummy medicine (placebo) in adults to see if it's more effective. For teenagers, the study will focus on how well icotrokinra works overall. We'll also be carefully checking for any side effects of the new medicine throughout the study.

Key takeaways

New medicine (icotrokinra) for moderate to severe ulcerative colitis is being tested.
Aimed at reducing inflammation and controlling symptoms.
Open to adults and teenagers (12 years and older).
Compares icotrokinra to a dummy medicine in adults; teenagers get icotrokinra.
Total study duration is about 5 years, with regular check-ups.
Participation costs are covered, and travel expenses reimbursed.

Who may be eligible?

You might be able to join this study if you are an adult aged 18 or older, or a teenager aged 12 to under 18. You need to have been diagnosed with ulcerative colitis at least 12 weeks before the study starts, and a doctor will have confirmed this using an examination of your bowel and tissue samples.

Your ulcerative colitis needs to be classed as moderate to severe and currently active when you join the study. This will be checked by a special score based on a camera examination of your bowel. You will also need to have had a full colonoscopy (bowel examination) to check for any abnormal cells in the last year, especially if you've had UC for a long time or it affects a large part of your bowel.

There are also some reasons why you might not be able to join. For example, if you have severe complications of UC like a sudden, serious flare-up or a very swollen bowel, or if you've had certain bowel surgeries recently, you won't be able to take part. Also, if you have a stoma (a surgically created opening in your tummy) or a history of certain abnormal cells in your bowel, you won't be eligible.

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 12 years old or older?
Do you have a confirmed diagnosis of ulcerative colitis?
Is your ulcerative colitis currently active (moderate to severe symptoms)?
Have you had a recent bowel examination (colonoscopy or sigmoidoscopy)?
Do you not have certain severe complications of UC like a very swollen bowel?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several stages over about five years. First, there's a 'Screening' period of up to 6 weeks where we check if you're suitable for the study. After that, for adults, there's a 12-week 'Induction' phase where you'll receive the study medicine (or a dummy medicine) daily. This is followed by a 40-week 'Maintenance' phase, still with daily medicine. For teenagers, there's a 52-week combined 'Induction and Maintenance' phase, with daily medicine.

Both adults and teenagers can then continue into a 'Long-term extension' phase for up to four years, still taking daily medicine. After your last dose of study medicine, there's a four-week 'Safety follow-up' period. Throughout the study, you'll have regular check-ups, which include physical examinations, blood tests, and heart tracings (ECGs). We'll also monitor for any side effects, including specific checks for tuberculosis and your mood. The study team will cover the cost of the study medicine and tests, and you'll receive some money back for travel or parking expenses.

Potential risks and benefits

It's important to know that while taking part in this study may offer some potential benefits, nothing is guaranteed. We hope that icotrokinra may improve your UC symptoms, but because it's a new medicine being investigated, we can't be certain. Some people find that participating in studies can lead to benefits from the regular medical check-ups and monitoring you'll receive. Also, your participation could help us learn valuable information that might help other people with UC in the future. However, there are potential risks. You might experience side effects from the study medicine or procedures, which can range from mild to severe, and in very rare cases, could even be life-threatening. These could include allergic reactions, your body reacting to the drug, or infections. There are also risks linked to procedures like camera examinations of your bowel, such as bleeding or discomfort. Not all possible side effects are known yet, but the study team will tell you immediately if any new important information comes to light. You will always have the right to withdraw from the study at any time.

Locations (9)

Fairfield General Hospital
Approximate
Bury, England
St George's University Hospital NHS Foundation Trust
City only
London, England
Addenbrooke's Hospital
Approximate
Cambridge, England
Kings College Hospital
Approximate
London, England
Whiston Hospital
City only
Prescot, England
Whipps Cross University Hospital
Unverified
London, England
Stepping Hill Hospital
Unverified
Stockport, England
Sheffield Children's Hospital
Unverified
Sheffield, England
Royal Hospital for Children and Young People
Unverified
Lothian, Scotland

Common questions

What is ulcerative colitis?

It's a long-lasting condition where the lining of your large bowel (colon) gets inflamed and develops small sores.

What is icotrokinra?

It's a new study medicine being tested to see if it can help reduce the inflammation that causes ulcerative colitis symptoms.

Will I definitely get the new medicine?

In the adult part of the study, some people will get icotrokinra, and some will get a dummy medicine (placebo). Teenagers will receive icotrokinra.

How long will I be in the study?

The total study could last about five years, including initial checks, treatment phases, and follow-up.

Do I have to pay to be in the study?

No, the study will cover the costs of the medicine and tests, and you'll get some reimbursement for travel expenses.

How to find out more

Jimmy Limdi

Official trial record

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