Active not recruitingPHASE3INTERVENTIONAL

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

This research study is looking at a new drug, guselkumab, for people living with Crohn's disease who have fistulas near their back passage. These fistulas can be very uncomfortable and challenging to treat. The main goal is to find out if guselkumab is effective at healing these fistulas and improving symptoms, and to check for any side effects. Participants will either receive guselkumab or a placebo (a dummy treatment with no active drug) to fairly compare their effects. This is a late-stage study, meaning the drug has already been tested in smaller groups and shows promise. Your participation could help us understand if this new treatment can offer a better quality of life for those affected.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen-Cilag Ltd.

Enrolment target

288

Start

27 Sep 2022

Estimated completion

25 Mar 2027

Fistulizing Crohns Disease Perianal Crohns Disease

What is this study about?

This study is designed to carefully look at a new treatment called guselkumab for people who have Crohn's disease, specifically when it affects the area around the back passage and causes fistulas. Fistulas are abnormal tunnels or connections that can form between organs or from an organ to the skin, and in Crohn's disease, they often appear around the anus. These can be very painful, leak, and significantly impact daily life.

The main purpose of this research is to see how well guselkumab works to treat these fistulas and if it helps them to heal. We will also be closely watching for any side effects to make sure the medication is safe. Some participants will receive guselkumab, while others will receive a placebo, which looks like the study drug but doesn't contain any active medication. This is a common and important way to fairly assess if the new drug is truly effective.

Finding new and better treatments for perianal fistulas in Crohn’s disease is really important because current options don't work for everyone, and it can be a very difficult condition to manage. By taking part in this study, you could help doctors learn more about this condition and potentially improve future care for many people living with Crohn's.

Key takeaways

Tests a new medication (guselkumab) for Crohn's-related fistulas around the back passage.
Compares guselkumab to a placebo (dummy treatment) to see if it works and is safe.
Designed for people whose current Crohn's treatments for fistulas haven't been effective.
Involves regular clinic visits, medical checks, and possibly scans.
Aims to find better treatment options for this challenging aspect of Crohn's disease.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to have a confirmed diagnosis of Crohn's disease for at least three months. You must also have at least one active fistula around your back passage that is draining, which will be confirmed by a special scan called an MRI.

Importantly, you would have previously tried up to two different types of strong medications for your Crohn's (like infliximab, adalimumab, vedolizumab, or similar drugs including JAK inhibitors) but found they either didn't work initially, stopped working over time, or you couldn't tolerate them due to side effects.

There are also some reasons why you might not be able to join. For example, if your Crohn's disease is very severe in other parts of your gut, if you have certain other medical conditions like rectovaginal fistulas, a stoma that is working, severe blockages, or uncontrolled infections. You also wouldn't be able to join if you have a history of certain other illnesses like systemic lupus erythematosus or multiple sclerosis, or if you have complications of Crohn's that might need surgery soon.

Quick self-check

Do you have a diagnosis of Crohn's disease for at least 3 months?
Do you have at least one active, draining fistula near your back passage?
Have you tried and not responded well to at least one strong Crohn's medication?
Are you between 18 years old and any age (no upper age limit)?
Do you not have very severe Crohn's in other parts of your gut, or other certain ongoing serious health issues?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you would receive either the study drug, guselkumab, or a placebo (a dummy drug). This will be decided by chance. You would have regular visits to the clinic so the study team can monitor your health, check your Crohn's symptoms, and evaluate how the fistulas are responding. This will involve physical examinations, blood tests, and potentially repeat scans like MRIs. You'll also be asked to report any changes in your health or any side effects you experience. The total length of your participation in the study, including all treatments and follow-up, will be explained in detail by the study team, but typically, studies like this involve regular visits over a period of many months.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks, including side effects from the study medication or placebo, which may range from mild to severe, and the possibility that the treatment may not be effective for your condition. It's crucial to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care. All known risks and benefits will be fully explained before you decide to take part.

Locations (154)

University of Alabama at Birmingham
Birmingham, United States
Yale University
New Haven, United States
University of Miami
Miami, United States
Gastroenterology Group Of Naples
Naples, United States
AdventHealth Medical Group Blood & Marrow Transplant at Orlando
Orlando, United States
Kansas University Medical Center
Kansas City, United States
University of Kentucky Chandler Medical Center
Lexington, United States
University of Louisville
Louisville, United States
Washington University School Of Medicine
St Louis, United States
Mount Sinai School of Medicine
New York, United States
Digestive Disease Specialists Inc
Oklahoma City, United States
Gastro One
Germantown, United States

+142 more sites — see the official record for the full list.

Common questions

What is guselkumab?

Guselkumab is a potential new medication being tested to treat fistulas in people with Crohn's disease. It works by targeting specific parts of your immune system.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the study medication but contains no active drug. It helps researchers fairly compare the new drug's effects.

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

No, during the main part of the study, neither you nor your study doctor will know whether you are receiving guselkumab or the placebo. This is to ensure fair and unbiased results.

How long will the study last?

The exact duration of your involvement will be explained by the study team, but studies like this usually involve follow-up over many months to properly assess the treatment's effects.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, without it affecting your medical care.