Active not recruitingPHASE2INTERVENTIONAL

A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis

This research study is for people aged 18 to 65 with a type of bowel disease called ulcerative colitis. This condition causes inflammation and sores in the large intestine. If you have moderate to severe ulcerative colitis and your current treatments (like other 'biologic' medicines) aren't working as well as they used to, your doctor might suggest this study. We are testing a new combination of medicines, called JNJ-78934804, alongside two other approved medicines called guselkumab and golimumab. The main goal is to find out if these treatments are safe and if they can help reduce symptoms of ulcerative colitis more effectively.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Janssen Research & Development, LLC

Enrolment target

577

Start

19 Sep 2022

Estimated completion

27 Mar 2029

Colitis, Ulcerative

What is this study about?

This study is about finding better ways to treat ulcerative colitis, a condition where the lining of your large intestine (also called the colon) becomes inflamed and develops small sores or ulcers. This can cause symptoms like tummy pain, diarrhoea, and needing to go to the toilet urgently. For many people, existing medicines help manage these symptoms, but for others, they might not work well, stop working over time, or cause difficult side effects.

In this study, doctors want to see if a new combination of medicines, called JNJ-78934804, might be a good option for people with moderate to severe ulcerative colitis who haven't found enough relief from other treatments. They will compare this new combination with two other approved medications, guselkumab and golimumab, to understand how well they work and if they are safe to use.

By taking part, you would be helping medical science learn more about ulcerative colitis and potentially discover new treatments that could improve the lives of many people living with this condition. Your health and safety would be closely monitored by a team of doctors and nurses throughout the study.

Key takeaways

This study is for people with moderate to severe ulcerative colitis.
It's for those whose current treatments aren't working well.
Researchers are testing a new combination of medicines against existing ones.
The aim is to find safer and more effective ways to manage ulcerative colitis.
Participation involves regular clinic visits for monitoring and treatment.

Who may be eligible?

This study is looking for volunteers who are between 18 and 65 years old and have been diagnosed with ulcerative colitis for at least three months. Importantly, your condition needs to be considered 'moderately to severely active' – meaning your symptoms are significantly affecting you. Also, you must have tried at least one other advanced treatment (like a 'biologic' medicine) for your ulcerative colitis, but it either didn't work well enough, stopped working, or you couldn't tolerate it due to side effects.

There are also some reasons why you might not be able to join. For example, if your ulcerative colitis is limited to just the furthest part of your bowel (the rectum) or is extremely severe, or if you have another type of bowel disease like Crohn's disease, you wouldn't qualify. You also couldn't take part if you have certain serious infections, a history of cancer within the last five years (some very specific exceptions apply, like certain skin cancers), or if your ulcerative colitis has spread throughout your entire bowel.

Women who are able to have children would need to agree to use effective contraception during the study. The study team will review all your medical information carefully to make sure it's safe and appropriate for you to participate.

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 ulcerative colitis for at least 3 months?
Is your ulcerative colitis currently causing moderate to severe symptoms?
Have you tried at least one 'biologic' or similar advanced medicine for UC that didn't work well or you couldn't tolerate?
Do you not have other serious infections or a recent history of cancer (excluding some specific types)?
Are you a woman of childbearing potential willing to use birth control during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve regular visits to the clinic where you will have check-ups, blood tests, and other assessments to monitor your health and how your body is responding to the treatment. You would receive one of the study medicines, which could be the new combination treatment, or guselkumab, or golimumab, or a placebo (an inactive substance that looks like the real medicine). The medicines are usually given as injections.

The study team will closely supervise your treatment and monitor any side effects you might experience. They will also keep track of your ulcerative colitis symptoms to see if the treatment is helping. The total duration of your participation in the study, including follow-up appointments, will be fully explained by the study team before you decide to join.

Potential risks and benefits

Taking part in a clinical study offers potential benefits, such as receiving close medical attention and access to new treatments that aren't yet widely available for ulcerative colitis. There's a chance the new treatment could improve your symptoms. However, as with all medicines, there are potential risks and side effects that the study doctor will explain in detail. The treatment might not work for you, or you might experience side effects. It's important to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (403)

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

Valley Gastroenterology Medical Group
Verified postcode
Arcadia, United States
Southern California Research Center
Verified postcode
Coronado, United States
Om Research LLC
Verified postcode
Lancaster, United States
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States
University of California San Francisco
Verified postcode
San Francisco, United States
University of Colorado
Verified postcode
Aurora, United States
Peak Gastroenterology Associates
Verified postcode
Colorado Springs, United States
Medical Research Center of Connecticut
Verified postcode
Hamden, United States
Yale University
Verified postcode
New Haven, United States
MedStar Georgetown University Hospital
Verified postcode
Washington D.C., United States
Pioneer Research Solutions Inc.
Verified postcode
Coconut Creek, United States
Digestive and Liver Disease Institute
Verified postcode
Kissimmee, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition that causes inflammation and small sores in the large intestine. It can lead to tummy pain, diarrhoea, and urgent trips to the toilet.

What are 'advanced therapies' in the context of this study?

Advanced therapies usually refer to newer, more powerful medicines, often called biologics, that target specific parts of the immune system to reduce inflammation in active ulcerative colitis. These are often used when standard treatments haven't worked.

What is a 'placebo'?

A placebo is an inactive substance that looks exactly like the real medicine but contains no active drug. It helps researchers understand if the real medicine is truly effective or if improvements are due to other factors.

Will I know which treatment I am receiving?

In many studies like this, you won't immediately know whether you are receiving the new medicine, an existing medicine, or the placebo. This helps ensure the study results are unbiased. However, the study team will always know for safety reasons, and you will be informed if your medical safety requires it.

How long will the study last?

The overall duration of your participation, including treatment and follow-up, will be fully explained by the study team. It can vary significantly between studies.