Active not recruitingPHASE2INTERVENTIONAL

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease

This research study is investigating a new combination medicine called JNJ-78934804 for adults between 18 and 65 years old who have moderate to severe Crohn's disease. The main goal is to find out if this new treatment works better or as well as two other existing medications, guselkumab and golimumab, in helping to manage Crohn's symptoms over a period of 48 weeks. Researchers will be observing the effects of these treatments to understand their effectiveness and safety. This type of study, called a Phase 2 trial, helps us learn more about potential new medicines before they might become widely available. Participants will be carefully monitored throughout the study.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

703

Start

22 Jul 2022

Estimated completion

05 Nov 2029

Crohn's Disease

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research study involving people. It's designed to look at a new combination treatment, JNJ-78934804, for Crohn's disease. Crohn's is a long-term condition that causes inflammation in the digestive system. If you have Crohn's that is moderate to severe, it means your symptoms are active and have a significant impact on your daily life.

The study aims to compare how well this new combination treatment works against two other medicines, guselkumab and golimumab, which are already used to treat inflammatory conditions. By comparing them, researchers hope to see if the new combination could be a good option for people with Crohn's. The study will last for 48 weeks, during which scientists will closely watch how each treatment affects people's symptoms and overall health.

Understanding how new treatments work is vital for improving care for conditions like Crohn's disease. This type of study, known as a Phase 2 trial, is an important step in developing new medications. It helps doctors and scientists gather important information about safety and effectiveness before a medicine can be considered for wider use.

Key takeaways

This study is for adults with moderate to severe Crohn's disease.
It tests a new combination treatment against two existing medicines.
The study aims to see how well the treatments work over 48 weeks.
It's a Phase 2 trial, an important step in medicine development.
Participants will have regular medical check-ups and monitoring.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 65 years old. You must have been diagnosed with Crohn's disease for at least three months, and your doctor must confirm that your Crohn's is currently moderately to severely active.

There will be other specific health requirements that the study doctors will check to make sure the study is safe and appropriate for you. For example, they will likely look at your general health, any other medical conditions you have, and any medications you are currently taking.

It's important that you discuss all your health information with the study team. They will review everything to determine if you meet all the necessary criteria to take part in the trial.

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 between 18 and 65 years old?
Have you been diagnosed with Crohn's disease for at least 3 months?
Has your doctor confirmed your Crohn's is currently moderately to severely active?
Are you able to attend regular study appointments for 48 weeks?

Answer every question to see your result.

What does participation involve?

If you join this study, you would primarily be testing a new combination treatment or one of two other established medications, or a placebo (a dummy treatment with no active medicine). You would have regular visits to the study clinic, where doctors and nurses would monitor your health closely. These visits would involve check-ups, blood tests, and possibly other assessments to see how you are responding to the treatment.

The medication would be given according to a specific schedule, which the study team would explain in detail. You would be asked to follow this schedule carefully. The study is planned to last for 48 weeks, and you would be expected to attend all scheduled appointments during this time. There would also likely be follow-up calls or visits after the main treatment period to track your long-term health.

Potential risks and benefits

Participating in a clinical trial might offer the potential benefit of accessing a new treatment before it's widely available, which could improve your Crohn's symptoms. However, like all medications, the treatments in this study may have side effects, some of which could be unknown or serious. There's also no guarantee that the treatment will work for you. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (456)

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

University of Alabama Liver Center
Verified postcode
Birmingham, United States
Del Sol Research Management, LLC
Verified postcode
Tucson, United States
Moore Clinical Trials, LLC
Verified postcode
Little Rock, United States
Om Research LLC
Verified postcode
Apple Valley, United States
Valley Gastroenterology Medical Group
Verified postcode
Arcadia, United States
Southern California Research Center
Verified postcode
Coronado, United States
Desert Gastroenterology Associates
Verified postcode
Lancaster, United States
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States
UCLA
Verified postcode
Los Angeles, United States
Hoag Memorial Hospital
Verified postcode
Newport Beach, United States
UCI Irvine Medical Center
Verified postcode
Orange, United States
Medical Associates Research Group, Inc.
Verified postcode
San Diego, United States

Common questions

What is Crohn's disease?

Crohn's disease is a long-term condition that causes inflammation in your digestive system, leading to symptoms like belly pain, diarrhoea, and weight loss.

What is a Phase 2 study?

A Phase 2 study is a stage of clinical research where a new treatment is tested in a small group of people to see if it works and to further check its safety.

What is a placebo?

A placebo is a substance that looks like a real medication but has no active ingredients. It's used in studies to help researchers compare the effects of the actual drug.

Will I know which treatment I'm getting?

In many studies like this, participants and sometimes even the doctors don't know who is receiving the active drug versus a placebo until the study ends. This is called 'blinding' and helps ensure the results are unbiased.

How long will the study last?

The main treatment part of this study is planned to last for 48 weeks, with regular check-ups during that time.