Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab

This study is looking at adults with a bowel condition called ulcerative colitis, specifically those with moderate to severe forms who haven't used certain types of advanced treatments before. It aims to see how well two approved medications, risankizumab and vedolizumab, work and how safe they are when compared to each other. Ulcerative colitis causes inflammation and bleeding in the large intestine. About 530 people around the world will be chosen randomly to receive either risankizumab or vedolizumab. Participants will have regular visits and receive their treatment, either through a drip (IV) or injections under the skin (subcutaneous). The study will last about 69 to 71 weeks.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

AbbVie

Enrolment target

573

Start

17 Jun 2025

Estimated completion

01 Sep 2028

Ulcerative Colitis

What is this study about?

This study is designed to help us understand more about ulcerative colitis (UC) and the treatments available for it. UC is a long-term condition that affects your large intestine (colon and rectum), causing inflammation, which can lead to symptoms like stomach pain, urgent need to go to the toilet, and bleeding.

Researchers want to compare two approved medicines, risankizumab and vedolizumab. Both are already used for people with moderate to severe UC. The main goal is to see which one works better and which has fewer side effects for adult patients who haven't tried similar advanced treatments before. By comparing them directly, doctors hope to get clearer information to help future patients and guide treatment choices. This could mean more effective ways to manage UC symptoms and improve quality of life for those affected.

Around 530 adults with moderate to severe UC will take part in this study, which is happening in many different places around the world. Participants will be randomly assigned to receive one of the two medicines. This means it's like a coin toss to decide which treatment you get, ensuring the comparison is fair. The study will carefully monitor everyone to see how their UC symptoms change and if they experience any side effects.

Key takeaways

This study compares two approved medicines for moderate to severe ulcerative colitis.
It aims to find out which medicine might work better and be safer for people who haven't tried similar treatments.
About 530 adults will take part worldwide, randomly assigned to one of the two treatments.
Treatment involves either IV drips or injections and requires regular clinic visits.
The study lasts for over a year, with careful monitoring of your health.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you would need to be an adult between 18 and 80 years old with an official diagnosis of ulcerative colitis for at least three months. Your ulcerative colitis also needs to be active and considered moderate to severe by the doctors involved in the study. You should have tried other standard medications for UC, such as aminosalicylates, certain steroids, or immunomodulators, and found they either didn't work well enough or caused problems.

There are also some reasons why you wouldn't be able to join. For example, if you've already received certain advanced treatments (called targeted therapies) for your UC, you wouldn't be eligible. This includes medicines like infliximab, adalimumab, and vedolizumab, among others. Also, if you have Crohn's disease, another type of inflammatory bowel disease, or certain complications from your UC like very severe inflammation that might need surgery soon, you couldn't participate. You also shouldn't have any serious infections when the study starts.

Quick self-check

Are you an adult between 18 and 80 years old?
Do you have a confirmed diagnosis of ulcerative colitis that has lasted at least 3 months?
Is your ulcerative colitis currently active and considered moderate to severe?
Have you tried other UC medicines (like aminosalicylates or certain steroids) and they didn't work well enough or caused problems?
Have you NOT used certain advanced treatments for UC before (like infliximab, adalimumab, or vedolizumab)?
Do you NOT have Crohn's disease or other serious UC complications that might need surgery?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll first have a screening period of about 35 days to check if you meet all the requirements. If you do, you'll be randomly assigned to receive one of the two study medicines: risankizumab or vedolizumab. This is like drawing straws, so you won't choose which one you get.

For risankizumab, you'd receive the medicine through a drip into your arm (intravenous or IV) at first, and then switch to injections under your skin (subcutaneous) for the rest of the treatment period. If you're assigned vedolizumab, you'd receive it through a drip (IV) throughout the entire study. You would need to attend regular clinic visits, where the medical team will carry out health checks, ask about any side effects you might be experiencing, and have you complete questionnaires about your health and how you feel. The treatment part of the study will last about 44 to 46 weeks, and the total time you'd be involved in the study, including screening, would be around 69 to 71 weeks.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from receiving a new or different treatment for your ulcerative colitis that could improve your symptoms. However, there's no guarantee that the treatment will work for you, or that its effects will be better than standard care. You might also experience side effects from the medication. The study involves regular visits and assessments, which could be more time-consuming than your usual care. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (270)

Gastro Health Research - St. Vincent'S East /ID# 275089
Birmingham, United States
Digestive Health Specialists /ID# 274785
Dothan, United States
East View Medical Research /ID# 276222
Mobile, United States
Arizona Health Research /ID# 274366
Chandler, United States
UC San Diego Health System /ID# 273538
La Jolla, United States
Gastro Care Institute /ID# 274873
Lancaster, United States
UCLA Health - Digestive Health & Nutrition Clinic /ID# 274827
Los Angeles, United States
Hoag Memorial Hospital Presbyterian /ID# 274364
Newport Beach, United States
California Medical Research Associates /ID# 274787
Northridge, United States
uc davis medical center - patient support services building /ID# 274251
Sacramento, United States
Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 273527
San Diego, United States
Danbury Hospital, Western Connecticut Health Network /ID# 275277
Danbury, United States

+258 more sites — see the official record for the full list.

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 pain and bleeding.

What are Risankizumab and Vedolizumab?

They are both approved prescription medicines used to treat moderate to severe ulcerative colitis by reducing the inflammation in your body.

How will I receive the study medicine?

Depending on which medicine you are given, you will receive it either through a drip into your arm (IV) or as an injection under your skin (subcutaneous).

How long will I be in the study?

The study will last for about 69 to 71 weeks, which includes a screening period and a treatment period.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any point, and your decision will not affect your future medical care.