Active not recruitingPHASE3INTERVENTIONAL

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

This study is investigating a new medication called guselkumab for people in the UK who have ulcerative colitis that is moderate to severe. Ulcerative colitis is a long-term condition that causes inflammation and ulcers in the lining of the large intestine, leading to symptoms like stomach pain and bloody diarrhoea. The main goal of this research is to see how well guselkumab works. Specifically, it wants to find out if the drug can help people go into remission, which means their symptoms significantly improve or disappear. Participants will receive different doses of guselkumab or a placebo (a dummy drug with no active ingredients). This is a Phase 3 study, meaning it's one of the final stages of testing for a new medicine before it might be approved for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

418

Start

13 Sep 2022

Estimated completion

06 Oct 2028

Colitis, Ulcerative

Results

Results from this study

Posted December 2025

Results have been published for this study.

Primary outcome

Percentage of Participants in Clinical Remission at Week 12

Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal), higher score indicated more severity. Mayo rectal bleeding subscore ranged from 0 (no blood seen) to 3 (blood alone passed), higher score indicated more severity. Mayo endoscopy subscore ranged from 0 (normal or inactive disease) to 3 (severe disease), higher score indicated more severity.

Full results on the registry

What is this study about?

This important study is focusing on a condition called ulcerative colitis. This is a type of inflammatory bowel disease where the lining of your large intestine (colon and rectum) becomes inflamed and develops small sores or ulcers. This can cause uncomfortable and often distressing symptoms like stomach pain, urgent need to go to the toilet, and diarrhoea, which can sometimes contain blood or mucus. When these symptoms are ongoing and disruptive, we call it 'moderately to severely active' ulcerative colitis.

Researchers are testing a new drug called guselkumab. This drug is given as an injection under the skin (subcutaneous). The main purpose of this study is to see if guselkumab can help people with moderately to severely active ulcerative colitis achieve what doctors call 'clinical remission'. This means a significant and lasting improvement in symptoms, and often an improvement in the inflammation inside the bowel.

To understand if guselkumab is effective, some participants will receive different doses of the drug, while others will receive a 'placebo'. A placebo looks exactly like the study drug but contains no active medicine. This comparison is vital in research to ensure that any improvements seen are due to the actual drug and not just other factors. This study is in 'Phase 3,' which means it's a large and crucial stage of testing conducted before a new medicine can be considered for approval for wider use.

Key takeaways

This study is testing a new drug, guselkumab, for moderate to severe ulcerative colitis.
It aims to see if the drug can help improve symptoms and achieve remission.
Some participants will receive the drug, others a placebo (dummy treatment).
It's a Phase 3 study, a key step before potential wider availability.
Careful checks are made to ensure you're suitable for the study.
Understanding the benefits and risks is important before you decide to join.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a confirmed diagnosis of ulcerative colitis for at least three months. Your ulcerative colitis must be moderate to severe, and you should have already tried standard treatments that haven't worked well for you, or you couldn't tolerate them.

There are also reasons why you might not be able to join. For example, if you have a different bowel condition like Crohn's disease, or if your ulcerative colitis is only affecting a very small part of your rectum. You also can't have had recent surgery that might affect the study results, or be taking certain medications that could interfere with the treatment.

Another important point is that you can't have an active, severe COVID-19 infection at the time of screening for the study.

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 been diagnosed with ulcerative colitis for at least 3 months?
Is your ulcerative colitis currently moderate to severe?
Have you tried other treatments for your UC that haven't worked well or you couldn't tolerate?
Do you have any other bowel conditions like Crohn's disease?
Are you currently undergoing surgery or planning surgery that could affect your UC?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first go through a screening process to make sure you fit all the criteria. If eligible, you would then be assigned to receive one of the different doses of guselkumab or a placebo. The study drug will be given as an injection under your skin.

Throughout the study, you would have regular visits to the clinic. During these visits, doctors and nurses would check your symptoms, take blood samples, and conduct other tests to see how you are responding to the treatment and monitor your health. They will carefully follow your progress and any side effects you might experience. The total duration of your involvement in the study, including follow-up after the main treatment period, would be clearly explained to you.

Potential risks and benefits

Participating in a clinical study means you might receive a new treatment that could improve your ulcerative colitis symptoms, potentially leading to remission. However, there's also a chance you might receive a placebo, meaning you wouldn't get the active drug. As with any new medicine, guselkumab might have side effects, which the study team will monitor closely. You will be given full information about the known risks before you decide to join, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (236)

Research Solutions of Arizona
Verified postcode
Litchfield Park, United States
Om Research LLC 1
Verified postcode
Apple Valley, United States
Om Research LLC
Verified postcode
Lancaster, United States
Medical Associates Research Group, Inc.
Verified postcode
San Diego, United States
Peak Gastroenterology Associates
Verified postcode
Colorado Springs, United States
Gastro Florida
Verified postcode
Clearwater, United States
I.H.S. Health. LLC
Verified postcode
Kissimmee, United States
Columbus Clinical Services LLC
Verified postcode
Miami, United States
Vista Health Research, LLC
Verified postcode
Miami, United States
Orlando Health
Verified postcode
Orlando, United States
Theia Clincial Research, LLC
Verified postcode
Temple Terrace, United States
Digestive Healthcare of Georgia, P.C
Verified postcode
Atlanta, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of your large intestine (colon and rectum), leading to symptoms like stomach pain, urgency, and bloody diarrhoea.

What is guselkumab?

Guselkumab is an investigational drug being tested to see if it can help improve symptoms and reduce inflammation in people with moderate to severe ulcerative colitis.

What is a placebo?

A placebo is a 'dummy' treatment that looks exactly like the study drug but contains no active medicine. It helps researchers understand if the new drug is truly effective.

What does 'clinical remission' mean?

Clinical remission means your ulcerative colitis symptoms have significantly improved or disappeared, and there are signs that the inflammation in your bowel has reduced.

Can I choose which treatment I get?

No, you cannot choose which treatment you receive. Participants are randomly assigned to either guselkumab or the placebo to ensure fair and accurate results.