Active not recruitingPHASE4INTERVENTIONAL

Determination of the Optimal Treatment Target in Ulcerative Colitis

This study aims to find the best way to treat ulcerative colitis (UC). UC is a long-term condition that causes inflammation in the large bowel. We know there are different ways to measure how well treatments work, such as looking at symptoms, checking the bowel with a camera, or examining tissue under a microscope. This research compares three different treatment approaches, each with a different goal: one focusing on symptom relief, another on symptom relief and bowel healing, and a third on symptom relief, bowel healing, and microscopic changes. By finding the best target, doctors can improve how they care for people with UC and help develop better medicines for the future.

At a glance

Status

Active not recruiting

Phase

PHASE4

Sponsor

Alimentiv Inc.

Enrolment target

672

Start

18 Feb 2020

Estimated completion

31 Mar 2026

Colitis, Ulcerative

What is this study about?

Ulcerative colitis (UC) is a condition where the lining of your large bowel (colon and rectum) becomes inflamed and develops sores, called ulcers. This can cause symptoms like tummy pain, bloody stools, and needing to go to the toilet urgently. Doctors use different ways to check how active your UC is and how well treatments are working. These include asking about your symptoms, using a camera to look inside your bowel, and even examining tiny pieces of tissue under a microscope.

This study wants to figure out the very best goal for treating UC. Is it enough just to get rid of your symptoms? Or should we aim for your bowel to look healthy inside when examined with a camera? Or should we go even further and make sure the tiny cells in your bowel look healthy under a microscope too? By comparing these different goals, the researchers hope to find the most effective approach to help people with UC live healthier lives.

Finding the optimal treatment goal is really important. It will help doctors in the UK and worldwide decide on the best ways to care for their patients with UC. It will also guide scientists and pharmaceutical companies in developing and testing new medications, ensuring they are truly effective at tackling the disease.

Key takeaways

The study aims to find the *best* treatment goal for Ulcerative Colitis.
It uses standard UC treatments, not experimental drugs.
Participants will be divided into three groups, each with a different treatment target.
Participation involves regular clinic visits, assessments, and close medical monitoring.
You can withdraw from the study at any time without penalty.
The findings could improve UC care for many people in the future.

Who may be eligible?

This study is looking for adults aged 18 or older who have been diagnosed with ulcerative colitis. Your UC needs to be moderately or severely active, which means you're currently experiencing symptoms like blood in your stools, and doctors have seen inflammation during a camera examination of your bowel.

You would not be able to join if you've already tried and not responded well to two or more advanced treatments for UC. Also, you must be able to fully participate in all parts of the study, understand what's involved, and give your permission to take part.

Before joining, doctors will also check for certain conditions like tuberculosis and hepatitis B or C. If you're a man or woman who could have children, and you're sexually active, you'll need to agree to use effective contraception during the study and for some time afterwards.

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?
Do you have a confirmed diagnosis of Ulcerative Colitis?
Is your UC currently moderately or severely active?
Have you *not* had inadequate response to two or more advanced UC treatments?
Are you able to agree to use contraception if sexually active and potentially able to have children?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of three groups. Each group will have a different target for your treatment, meaning the doctors will aim to get your UC to a certain level of improvement using standard medications. Your medications will be adjusted over time based on how your body is responding to try and reach your group's specific treatment target.

Throughout the study, you will have regular visits to the clinic where doctors will check your symptoms and perform different assessments. These assessments might include blood tests, stool samples, and occasionally camera examinations (endoscopies) to look inside your bowel. The study is designed to follow your progress and treatment effectiveness over a period of time, although the total duration isn't specified here, it will involve ongoing monitoring and follow-up care until your group's target is either met or a certain period has passed.

Potential risks and benefits

Taking part in a study like this may offer some potential benefits, such as receiving close monitoring and careful adjustment of your UC treatment to achieve specific improvement goals. However, as with any medical study, there are potential risks, primarily related to the treatments you will receive, which are standard medications for UC, and the procedures, such as blood tests or endoscopies, which carry their own small risks. You will be fully informed of all potential risks before you decide to join. It is very important to remember that participating in any clinical trial is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (58)

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

St. Joseph Mercy Hospital/Huron Gastroenterology Associates
Verified postcode
Ypsilanti, United States
Icahn School of Medicine at Mt Sinai Hospital
Verified postcode
New York, United States
New York-Presbyterian/Weill Cornell Medical Center
Verified postcode
New York, United States
Digestive Health Partners - Asheville Gastroenterology Associate
Verified postcode
Asheville, United States
Atrium Health (Carolinas HealthCare)
Verified postcode
Charlotte, United States
Gomel Regional Clinical Hospital
Verified postcode
Homyel, Belarus
Vitebsk Regional Clinical Hospital
Verified postcode
Vitebsk, Belarus
Imelda Ziekenhuis Bonheiden
Verified postcode
Bonheiden, Belgium
University Hospital Ghent
Verified postcode
Ghent, Belgium
UZ Leuven - University Hospital Gasthuisberg
Verified postcode
Leuven, Belgium
University of Calgary
Verified postcode
Calgary, Canada
GIRI (GI Research Institute)
Verified postcode
Vancouver, Canada

Common questions

What is Ulcerative Colitis (UC)?

UC is a long-term condition causing inflammation and sores in the lining of your large bowel (colon and rectum).

What does 'treatment target' mean?

It's the specific goal doctors aim for when treating your UC, like getting rid of symptoms or healing the bowel lining.

Will I get a new or experimental drug?

No, this study uses standard, approved treatments for UC. It's about finding the best way to use them to achieve different goals.

How long will I be in the study?

The study involves ongoing monitoring and follow-up until your group's treatment target is met or a certain period passes. The exact duration will be explained by the study team.

What if I don't like my assigned treatment group?

You can withdraw from the study at any time, and this will not affect your standard medical care for UC.