Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis

This research is testing a treatment called risankizumab for people with ulcerative colitis, a condition that affects the large bowel. The main aim is to understand how effective and safe risankizumab is long-term for individuals who have already responded well to it in an earlier study. The study is divided into several parts, some comparing the medicine to a dummy treatment (placebo), and others where everyone receives the active drug. The goal is to ensure people can continue receiving this treatment if it works for them until it's more widely available. It's open to adults aged 16 to 80.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

1,242

Start

28 Aug 2018

Estimated completion

01 Feb 2029

Ulcerative Colitis (UC)

What is this study about?

You might have heard about clinical trials, which are research studies that test new medicines or treatments to see if they are safe and if they work. This particular study is looking at a medicine called risankizumab for people who have ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of the large bowel and rectum becomes inflamed, causing symptoms like tummy pain and diarrhoea.

The main aim of this study is to find out more about how well risankizumab works and how safe it is over a longer period. This study is specifically for people who have already taken part in a different study (called M16-067) and whose ulcerative colitis symptoms improved after being treated with risankizumab. The researchers want to see if these good effects continue.

Because this is an important part of understanding how new medicines work, the study is set up in a few stages. Some people involved will continue to receive risankizumab, while others might receive a 'dummy' treatment (called a placebo) for a period, so researchers can compare the effects. There are also stages where everyone receives the active medicine. Ultimately, the study wants to make sure people who benefit from risankizumab can keep getting it, especially if it's not yet easily available everywhere.

Key takeaways

This study evaluates risankizumab for ulcerative colitis.
It's for people who improved with risankizumab in a previous study.
The study aims to check the long-term safety and effectiveness of the medicine.
Participation involves regular clinic visits and health checks.
You might receive either the active drug or a dummy treatment at different times.
The goal is to ensure continuous care for those who benefit from the treatment.

Who may be eligible?

This study is looking for a specific group of people with ulcerative colitis. To be able to take part, you must have previously participated in an earlier study called M16-067 and your ulcerative colitis symptoms must have shown a good improvement during that study. This means the treatment was working for you.

There are also some things that would mean you couldn't join. For example, if you are allergic to risankizumab or any of its ingredients, or if you had a serious side effect in the previous study that your doctor thinks makes it unsuitable for you to continue. Your doctor will also need to agree that you are generally suitable for the study, and that you followed all the rules about your medications in the previous 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.

Have I already taken part in Study M16-067?
Did my ulcerative colitis symptoms improve significantly in that previous study?
Am I between 16 and 80 years old?
Do I have any known allergies to the study medicine or its ingredients?
Am I willing to follow the study's medication and visit schedule?

Answer every question to see your result.

What does participation involve?

If you join this study, you will likely be involved for a significant period. The study is made up of different parts, some lasting 52 weeks (around a year). You will have regular visits to the clinic where you will be monitored closely. Some parts of the study will involve randomly assigning you to either receive risankizumab or a placebo (a dummy medicine without any active drug). Other parts of the study mean you will definitely receive risankizumab.

During your visits, you'll have various tests and assessments to see how your ulcerative colitis is doing and to check your general health. This might include blood tests, physical examinations, and possibly endoscopies (a procedure to look inside your bowel). The aim is to make sure you continue to receive risankizumab if it's helping you, until the medicine is available for everyone or you can get it locally. The total duration of your involvement could extend quite a long time to ensure continuous treatment.

Potential risks and benefits

Taking part in a study like this means you might benefit from continuing a treatment that has already helped your ulcerative colitis. This could lead to a reduction in your symptoms and an improved quality of life. However, like all medicines, risankizumab can have side effects, and some people may not respond to the treatment. There's also a chance you might receive a placebo for a period, meaning your symptoms could return or worsen during that time. You will be closely monitored throughout the study for any side effects or changes in your condition. Remember, you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (426)

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

Southern California Res. Ctr. /ID# 169659
Verified postcode
Coronado, United States
Hoag Memorial Hosp Presbyterian /ID# 218347
Verified postcode
Irvine, United States
UC San Diego Health System /ID# 160430
Verified postcode
La Jolla, United States
United Medical Doctors /ID# 158574
Verified postcode
Los Alamitos, United States
Cedars-Sinai Medical Center /ID# 163848
Verified postcode
Los Angeles, United States
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 200934
Verified postcode
Los Angeles, United States
UCSF Medical Center - Mount Zion /ID# 201209
Verified postcode
San Francisco, United States
Peak Gastroenterology Associates, PC /ID# 165838
Verified postcode
Colorado Springs, United States
Rocky Mountain Pediatric Gastroenterology /ID# 207173
Verified postcode
Lone Tree, United States
Duplicate_Medical Research Center of CT /ID# 160287
Verified postcode
Hamden, United States
Yale Univ Digestive Diseases /ID# 213265
Verified postcode
New Haven, United States
South Lake Pain Institute, Inc /ID# 162859
Verified postcode
Clermont, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-lasting condition where the lining of your large bowel and rectum becomes red and swollen, causing symptoms like tummy pain and needing to go to the toilet urgently.

What is risankizumab?

Risankizumab is a medicine being tested to see if it can help people with ulcerative colitis. It works by targeting specific parts of your immune system that cause inflammation.

Why is this study only for people who have been in a previous study?

This study is designed to follow up on people who have already shown improvement with risankizumab in an earlier study, to see if the treatment continues to be effective and safe long-term.

Will I definitely receive the active medicine?

Not necessarily for the whole study. Some parts involve comparing risankizumab to a placebo (dummy treatment), while other parts ensure everyone receives the active medicine.

How long will I have to be in the study?

The study has different stages, some lasting 52 weeks (about a year), and could extend further to ensure you continue to receive treatment if it's helping you.