Active not recruitingPHASE3INTERVENTIONAL

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

This study is investigating a new medicine, guselkumab, for people with Crohn's disease. The main goal is to see if this treatment can help heal all layers of the digestive tract, not just the surface. Doctors will use special scans, like MRI, to measure this healing at 48 weeks. They are also looking into how well guselkumab works generally in managing Crohn's disease symptoms and improving a patient's overall condition. This is a Phase 3 study, meaning it's one of the final steps before a new medicine might be approved for wider use. It aims to provide more evidence about guselkumab's effectiveness and safety.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen-Cilag Ltd.

Enrolment target

120

Start

17 Apr 2024

Estimated completion

06 Mar 2028

Crohn's Disease

What is this study about?

Crohn's disease is a type of inflammatory bowel disease (IBD) that causes long-lasting inflammation in your digestive tract. This inflammation can lead to symptoms like tummy pain, severe diarrhoea, tiredness, and weight loss. While some treatments help manage the symptoms, doctors are always looking for medicines that can offer deeper healing.

This study is focusing on a new medicine called guselkumab. The main idea behind this research is to see if guselkumab can do more than just make you feel better; they want to know if it can actually heal all the layers of your digestive tract where Crohn's disease causes problems. This is often called 'transmural healing'. To check this, doctors will use special scans at 48 weeks, which are very good at showing what's happening inside your gut.

By looking at this deep healing, researchers hope to understand if guselkumab can change the way Crohn's disease progresses over time, potentially leading to longer-lasting relief and better health for patients. This type of research is really important because it helps scientists develop better treatments and gives people with Crohn's disease more options for managing their condition effectively.

Key takeaways

This study evaluates a new drug, guselkumab, for Crohn's disease.
It aims to see if the drug can heal all layers of the gut (transmural healing).
Special scans will be used to check for healing and disease activity.
You must have active Crohn's disease and have tried other treatments.
It's a Phase 3 study, meaning it's a key step in drug development.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) who has had Crohn's disease for at least three months. Your Crohn's disease must currently be active, meaning you have moderate to severe symptoms like frequent loose stools or regular belly pain. Doctors will use a scoring system to confirm your disease activity.

Another important requirement is that you must have active inflammation deep within your gut walls, which will be checked with a special scan. You also need to have tried and not responded well to, or couldn't tolerate, at least one other standard treatment for Crohn's disease. This includes conventional medicines or certain advanced therapies like biologics.

Some things would mean you couldn't join the study. For example, if you have complications from Crohn's disease that might need surgery soon, like severe blockages or certain types of fistulas (abnormal connections) or abscesses (pockets of infection). If you have an abscess, it needs to be fully treated and cleared up well before the study begins before you can be considered.

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?
Have you had Crohn's disease for at least 3 months?
Do you currently have active Crohn's disease with ongoing symptoms?
Have you previously not responded well to, or couldn't tolerate, other Crohn's treatments?
Do you have active inflammation deep in your gut walls, as confirmed by scans?
Do you currently not have severe complications of Crohn's disease that might need surgery soon?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study medication, guselkumab. You will have regular visits to the clinic for check-ups, blood tests, and to discuss how you're feeling. A key part of the study involves having special scans, like an MRI, to look at the healing of your digestive tract, especially at 48 weeks. You'll also be asked about your symptoms and quality of life regularly.

The study involves several assessments over a total duration, which will be explained in detail. This includes monitoring for any side effects or changes in your health. All procedures and medication will be provided as part of the study. You'll have a dedicated medical team supporting you throughout your participation.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new treatment, guselkumab, which could potentially improve your Crohn's disease symptoms and lead to better healing of your gut. However, like all medications, guselkumab has potential risks and side effects, which your study doctor will explain fully. There's also no guarantee that the treatment will work for you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (84)

Center for Colitis and Crohns Disease University of California
Verified postcode
San Francisco, United States
The University of Chicago Medical Center (UCMC)
Verified postcode
Chicago, United States
Washington University School Of Medicine
Verified postcode
St Louis, United States
Medical University of South Carolina
Verified postcode
Charleston, United States
The Queen Elizabeth Hospital
Verified postcode
Adelaide, Australia
Concord Repatriation General Hospital
Verified postcode
Concord, Australia
Northern Hospital
Verified postcode
Melbourne, Australia
Fiona Stanley Hospital
Verified postcode
Murdoch, Australia
Mater Hospital Brisbane
Verified postcode
South Brisbane, Australia
AZ Maria Middelares
Verified postcode
Ghent, Belgium
CHU de Liege
Verified postcode
Liège, Belgium
Vitaz
Verified postcode
Sint-Niklaas, Belgium

Common questions

What is transmural healing?

Transmural healing means that all the layers of your gut wall, not just the inner surface, are showing signs of healing from the inflammation caused by Crohn's disease.

What is guselkumab?

Guselkumab is a type of medicine that targets specific parts of your immune system to help reduce inflammation in conditions like Crohn's disease.

What is a Phase 3 study?

A Phase 3 study is one of the final stages of clinical research. It's a large study that compares the new treatment to existing ones or a placebo to confirm its effectiveness and safety before it can be approved for general use.

Will I know if I'm getting the active drug or a placebo?

In many studies like this, participants are 'blinded,' meaning you won't know if you're receiving the study drug or a placebo, to ensure fair results. Your doctor will explain the study design to you.

How long will I be in the study?

The full duration of your participation in the study, including follow-up, will be clearly explained by the research team before you decide to join.