RecruitingPhase IIIInterventional

A study of guselkumab versus risankizumab in participants with moderately to severely active Crohn's Disease

This study is looking at two medicines, guselkumab and risankizumab (also known as Skyrizi), for adults with Crohn’s Disease that is moderately to severely active. Crohn’s is a long-term condition causing inflammation in the digestive system. Both guselkumab and risankizumab block a protein called IL-23, which helps to reduce this inflammation. While both are approved treatments, we need to know which one works best. This study will involve people randomly receiving one of these two medicines for about a year, followed by safety checks. The aim is to find out which treatment is more effective for patients who haven't responded well to other therapies.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

Janssen-Cilag International N.V.

Enrolment target

530

Start

19 Apr 2026

Estimated completion

16 Nov 2027

Moderately to severely active Crohn's Disease

What is this study about?

Crohn's disease is a lasting condition that affects your digestive system, causing inflammation that can worsen over time and lead to ulcers. While there are treatments available, it's not always clear which one works best for everyone, especially if other medicines haven't helped. This study is focused on two specific medicines: guselkumab and risankizumab (you might know risankizumab as Skyrizi). Both of these medicines work in a similar way by targeting a protein in your body called IL-23. By blocking IL-23, these medicines help to calm down the inflammation in your gut that's caused by Crohn's disease.

The main goal of this study is to compare guselkumab and risankizumab to see which one is more effective at treating moderate to severe Crohn's disease. This is particularly important for people whose condition hasn't improved with other treatments. By understanding how these two medicines stack up against each other, doctors can make more informed decisions about the best course of treatment for patients like you in the future.

Taking part in a study like this helps improve our understanding of Crohn's disease and its treatments. Even if you don't personally experience a benefit, the information gathered can be very valuable for other people with Crohn's disease. The study is carefully planned and supervised by medical professionals to ensure your safety throughout the process.

Key takeaways

Compares two medicines, guselkumab and risankizumab, for moderate to severe Crohn's.
Aimed at adults who haven't responded well to other Crohn's treatments.
Involves random assignment to one medicine for about a year of treatment.
Includes regular health checks and safety monitoring.
Participation helps future patients, though personal benefit isn't guaranteed.
All study costs covered, and travel expenses reimbursed.

Who may be eligible?

This study is for adults aged 18 or older who have been diagnosed with moderately to severely active Crohn's disease. Importantly, you should have tried other advanced treatments in the past, but they haven't worked well enough for your Crohn's.

To check if you are suitable, doctors will look at your Crohn's disease activity, including your symptoms and how much inflammation is visible inside. They will also need to make sure you don't have certain complications of Crohn's, like severe blockages or abscesses, and you haven't had recent major surgery on your bowel.

There are also specific medical checks to make sure the study treatments would be a good fit and wouldn't put your health at risk. The study team will review all your medical information to see if you meet all the necessary requirements.

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 old or older?
Do you have moderate to severe Crohn's disease?
Have other advanced Crohn's treatments not worked for you?
Do you currently have inflammation in your digestive system?
Do you not have certain complications like severe bowel blockages or abscesses?
Are you willing to attend regular appointments and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several stages over quite a long period. First, there's a 'screening period' of up to 5 weeks where doctors will check if you're suitable. If you are, you'll then enter the 'treatment period' which lasts for about a year (up to 52 weeks). During this time, you'll be randomly assigned to receive either guselkumab or risankizumab.

Your participation will involve regular visits for physical examinations, blood tests, and other checks like vital signs (blood pressure, heart rate) and pregnancy tests if necessary. You'll also be checked for tuberculosis. After your last dose of medication, there will be a 'safety follow-up' period lasting up to 12 or 16 weeks, where doctors will continue to monitor your health. All potential side effects will be carefully watched until the very end of the study, which could be up to 165 weeks in total.

Potential risks and benefits

There is no guarantee that you will personally benefit from taking part in this study. However, some people find comfort in regular medical check-ups and the close monitoring of their health that a study provides. The information gathered from your participation could also help others with Crohn's disease in the future. As with any medicine or medical procedure, there are potential risks. The study drugs might cause side effects, which can range from mild to severe, or even life-threatening for a very small number of people. These can include allergic reactions, a higher chance of infections (like tuberculosis), or effects on your liver or blood fat levels. Some study procedures, like certain scans or endoscopies, also carry their own small risks, such as bleeding or a tear in the bowel. You will receive very detailed information about all known and potential risks before you decide to join, and you have the right to withdraw from the study at any time.

Locations (8)

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

University College London Hospitals NHS Foundation Trust
City only
London, England
University Hospitals Coventry and Warwickshire NHS Trust
City only
Coventry, England
Barts Health NHS Trust
City only
London, England
London North West University Healthcare NHS Trust
City only
Harrow, England
Imperial College Healthcare NHS Trust
City only
London, England
Royal Free London NHS Foundation Trust
City only
London, England
Norfolk and Norwich University Hospitals NHS Foundation Trust
City only
Norwich, England
Chelsea and Westminster Hospital NHS Foundation Trust
City only
London, England

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition that causes inflammation in your digestive system, which can lead to pain, diarrhoea, and other symptoms.

What are guselkumab and risankizumab?

These are two approved medicines that target a specific protein in your body to reduce the inflammation caused by Crohn's disease.

How long will the study last?

The main treatment part lasts about a year, but with screening and follow-up, your total participation could be up to 165 weeks (over three years).

Will I have to pay to be in the study?

No, there are no costs for you to be in the study. The study sponsors will cover the cost of the study drugs and tests, and you may be reimbursed for travel costs.

What if new risks are found during the study?

Your study doctor will tell you immediately about any new information, especially anything that might make you reconsider your participation.

How to find out more

Besarte Vrellaku

JanssenUKRegistryQueries@its.jnj.com - Official trial record

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