Active not recruitingPHASE2, PHASE3INTERVENTIONAL

A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease

This research is testing a new medicine, guselkumab, for people with Crohn's disease that is moderately to severely active. The main goal is to find out if guselkumab is effective in improving symptoms and reducing inflammation in the gut, and to make sure it's safe to use. The study will compare guselkumab at different doses to an existing treatment (ustekinumab) and a placebo (a dummy medicine with no active ingredients). This will help doctors understand the best way to use guselkumab if it becomes an approved treatment for Crohn's disease. Participants will be carefully monitored throughout the study to track their progress and watch for any side effects.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

1,409

Start

13 Apr 2018

Estimated completion

28 Jan 2028

Crohn's Disease

What is this study about?

This study is investigating a new medicine called guselkumab for adults who have Crohn's disease that is currently active, meaning they are experiencing symptoms. Crohn's disease is a type of inflammatory bowel disease where parts of the digestive system become inflamed, causing pain, diarrhoea, and other problems. Current treatments aim to reduce inflammation and manage symptoms, but they don't work for everyone, or they might stop working over time. That's why researchers are always looking for new and better options.

The main purpose of this study is to see how well guselkumab works in reducing the symptoms and inflammation associated with moderately to severely active Crohn's disease. They also want to understand its safety. The study will compare different doses of guselkumab to an existing commonly used Crohn's medicine (ustekinumab) and a 'dummy' medicine called a placebo. By doing this, doctors can learn if guselkumab is a helpful new treatment and what the best dose might be.

This research is made up of a few different parts, conducted in stages. First, a dose-finding stage (Phase 2) helps researchers work out the best doses of guselkumab to use. Then, two larger studies (Phase 3) will confirm how effective and safe these selected doses are. If you complete the main part of the study, you might also have the option to join a longer-term study to see how the medicine works over an even longer period.

Key takeaways

This study is testing a new medicine, guselkumab, for active Crohn's disease.
It aims to see how well guselkumab works and if it's safe compared to other treatments or a placebo.
Participation involves regular clinic visits, tests, and receiving a study medicine for about 48 weeks.
You must have moderately to severely active Crohn's and have tried other treatments without success.
There might be benefits from a new treatment, but also potential risks and side effects.
You can stop participating in the study at any time without affecting your normal care.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. You need to have been diagnosed with Crohn's disease for at least three months, and your disease must currently be active, meaning you have moderate to severe symptoms like frequent bowel movements and abdominal pain. Doctors will use specific tests to confirm that your Crohn's is active enough for the study. You also need to have tried and not responded well to, or couldn't tolerate, other common Crohn's treatments, including biologic medicines.

There are also some reasons why you might not be able to join. For example, if you have another type of inflammatory bowel disease like ulcerative colitis, or if your Crohn's has led to certain complications like severe blockages in your gut. You also can't be taking certain other Crohn's medications or participating in other studies at the same time. Women who could become pregnant will need to have a negative pregnancy test to start the study. The study team will review all your medical information carefully to see if this study is right for you.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Crohn's disease for at least 3 months?
Is your Crohn's disease currently moderately to severely active (e.g., with frequent diarrhoea or tummy pain)?
Have you tried other Crohn's medicines (including biologics) but they haven't worked well, or you couldn't tolerate them?
Are you not currently pregnant or planning to become pregnant during the study?
Do you not have active complications of Crohn's disease like severe gut blockages?

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

What does participation involve?

If you join this study, your involvement will last for about 48 weeks, which is nearly a year. During this time, you will have regular visits to the study clinic where you'll have check-ups, blood tests, and other assessments to monitor your health and how the study medicine is affecting your Crohn's. You will receive either one of the different doses of the new medicine (guselkumab), an existing Crohn's medicine (ustekinumab), or a placebo (a dummy medicine). The type of medicine you receive will be decided by chance, like flipping a coin.

Throughout the study, doctors and nurses will closely monitor your Crohn's symptoms, inflammation levels, and any side effects you might experience. After the initial 48 weeks, you might be offered the chance to continue in a longer-term study if you and the study doctors agree it is appropriate. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new investigational treatment for your Crohn's disease that could improve your symptoms and quality of life. You will also receive careful medical monitoring and support from experienced healthcare professionals throughout the study. However, like all medicines, guselkumab may have side effects, and some are not yet fully known. There's also a chance you might receive the placebo and not the active medicine, meaning your Crohn's symptoms might not improve. Taking part in studies involves regular clinic visits, blood tests, and other procedures, which can be time-consuming. You always have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (578)

Digestive Health Specialists of the Southeast
Dothan, United States
Internal Medicine Center
Mobile, United States
University of Arizona
Tucson, United States
Advanced Research Center Inc
Anaheim, United States
Paul Wallace MD
Beverly Hills, United States
University Of California San Diego
La Jolla, United States
Om Research LLC
Lancaster, United States
Allameh Medical Corp
Mission Viejo, United States
United Gastroenterologists
Murrieta, United States
Clinnova Research
Orange, United States
Inland Empire Liver Foundation
Rialto, United States
UC Davis Medical Center
Sacramento, United States

+566 more sites — see the official record for the full list.

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition where parts of your digestive system become inflamed. This can cause tummy pain, diarrhoea, tiredness, and weight loss.

What is guselkumab?

Guselkumab is a new medicine being tested. It works by targeting specific parts of your immune system that are overactive in Crohn's disease to help reduce inflammation.

What is a placebo?

A placebo is a 'dummy' medicine that looks just like the study drug but contains no active ingredients. It's used to compare the real drug's effects.

How long will the study last?

The main part of the study will last for about 48 weeks (nearly a year). After this, you might have the option to join a longer-term part of the study.

Can I leave the study at any time?

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