Active not recruitingPHASE2, PHASE3INTERVENTIONAL

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

This research study is testing a medicine called guselkumab for people who have ulcerative colitis (UC). UC is a long-term condition where the large bowel becomes inflamed. If your UC is active and causing moderate to severe symptoms, and other treatments haven't worked well, this study might be for you. We're looking to find out if guselkumab can help reduce symptoms like frequent bowel movements, pain, and bleeding, and if it's a safe treatment option. This study will involve two main stages, known as phases 2 and 3, which helps us gather important information about this new medicine.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

1,064

Start

26 Sep 2019

Estimated completion

29 Sep 2027

Ulcerative Colitis

Results

Results from this study

Posted November 2024

Results have been published for this study.

Primary outcome

Induction Study 1: Percentage of Participants With Clinical Response at Week I-12

Clinical response was defined as a decrease from induction baseline in the modified Mayo score by greater than or equal to (\>=) 30 percent (%) and \>=2 points, with either a \>=1 point decrease from baseline (Week 0 of IS-1) in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The modified Mayo scores consisted of 3 subscores: stool frequency, rectal bleeding and endoscopic subscore as determined during central review, each subscore graded from 0 (normal) to 3 (severe) with higher scores indicating more severe disease. These individual subscores were summed up to give a total modified Mayo score range of 0 (normal) to 9 (severe disease), where higher scores indicated more severe disease activity. This outcome measure was planned to be analyzed for specified arms only.

Full results on the registry

What is this study about?

This study is investigating a new medication called guselkumab for individuals living with ulcerative colitis (UC). UC is a condition that causes inflammation and sores in the lining of your large intestine. For many, managing UC means dealing with uncomfortable and often disruptive symptoms like tummy pain, urgent trips to the toilet, and fatigue. When these symptoms are moderate to severe and aren't getting better with usual treatments, it can really affect daily life.

The main goal of this study is to see if guselkumab can effectively reduce these symptoms and improve the quality of life for people with UC. It also aims to check how safe this medicine is to use. This kind of research is really important because it helps doctors and scientists understand if new treatments can offer better options for people struggling with long-term conditions like UC.

Taking part in a study like this means you would be helping medical science learn more about new treatments, potentially benefiting others with UC in the future. It’s part of a careful process of testing new medicines to make sure they are both helpful and safe before they can be widely used.

Key takeaways

This study is for adults with moderate to severe ulcerative colitis.
It's testing a new medicine called guselkumab.
The study aims to see if guselkumab helps symptoms and is safe.
You might receive the new medicine or a placebo.
You'll have regular check-ups and monitoring.
Your rights and safety are a top priority.

Who may be eligible?

To join this study, you must have a proper diagnosis of ulcerative colitis. Your doctor will need to confirm that your UC is currently active, meaning your symptoms are moderate to severe. It’s also important that standard treatments haven't worked well enough for you, or you haven't been able to tolerate them.

There are also some reasons why you might not be able to join. For example, if your UC is only in a very small part of your bowel (less than 20 centimetres, or about 8 inches), or if it’s only in the very end of your bowel (the rectum), this study wouldn't be suitable. You also can’t take part if you have other bowel conditions like Crohn's disease, or if you have a stoma (a surgical opening on your tummy).

Your study doctor will also check your blood test results and any other treatments you might be taking to make sure they fit with the study rules.

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.

Do you have a confirmed diagnosis of ulcerative colitis?
Are your ulcerative colitis symptoms currently moderate to severe?
Have your usual treatments not worked well enough or caused problems?
Are you 18 years old or over?
Do you not have other bowel conditions like Crohn's disease?
Do you not have a stoma?

Answer every question to see your result.

What does participation involve?

If you choose to join this study, you would receive either the new medicine, guselkumab, or a placebo, which looks like the real medicine but contains no active drug. You wouldn't know which one you're getting, as this helps us fairly understand the medicine's effects. You'll have regular visits to the clinic for check-ups, which might include having physical exams, blood tests, and discussing your symptoms. These visits are important for the study team to monitor your health and how you're responding to the treatment. The total duration of your participation in the study, including all treatments and follow-up checks, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from a new treatment that could improve your symptoms. However, there's no guarantee that the treatment will work for you, and like all medicines, guselkumab could have side effects, which the study team will discuss in detail. You will always have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (392)

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

Om Research LLC
Verified postcode
Lancaster, United States
UCLA
Verified postcode
Los Angeles, United States
Peak Gastroenterology Associates 1
Verified postcode
Colorado Springs, United States
Florida Research Network, LLC
Verified postcode
Gainesville, United States
University of Florida Health Jacksonville
Verified postcode
Gainesville, United States
Harmony Medical Research Institute, Inc.
Verified postcode
Hialeah, United States
UF Health Jacksonville Gastroenterology Emerson
Verified postcode
Jacksonville, 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
Care Access Research, Orlando
Verified postcode
Orlando, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large bowel becomes inflamed and develops small sores, causing symptoms like tummy pain and urgent bowel movements.

What is guselkumab?

Guselkumab is the new medicine being tested in this study to see if it can help people with active ulcerative colitis.

What is a placebo?

A placebo is a substance that looks like the real medicine but has no active ingredients. It's used in studies to compare against the new medicine.

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of the study, neither you nor your study doctor will know if you're receiving guselkumab or the placebo.

How long will the study last?

The study team will tell you the exact length of time you'd be involved, including all treatments and follow-up appointments.