Active not recruitingPHASE2INTERVENTIONAL

A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis

This research study is for adults with moderate to severe ulcerative colitis, a condition that causes swelling and bleeding in the large bowel. We are trying to find out if a new medicine, lutikizumab, is safe and effective. We will compare it to an existing treatment called adalimumab. Participants will receive one of these medicines, and we will closely monitor their symptoms and any side effects. The study involves regular hospital or clinic visits, and will help us understand if lutikizumab could be a good treatment option for ulcerative colitis.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

AbbVie

Enrolment target

156

Start

23 Mar 2024

Estimated completion

01 Sep 2027

Ulcerative Colitis

What is this study about?

Ulcerative colitis (UC) is a long-term condition that affects the large bowel (colon and rectum). It causes inflammation, which can lead to symptoms like tummy pain, diarrhoea, and blood in your poo. This study is testing a new medicine called lutikizumab for adults who have moderate to severe UC.

The main goals of this study are to see how safe lutikizumab is and how well it helps control UC symptoms. We'll also be comparing it to another medicine, adalimumab, which is already used to treat UC. By doing this comparison, doctors can learn if lutikizumab could be a new and effective treatment option. The study will look at how your symptoms change and if you experience any side effects.

About 200 adults with UC from around the world will take part. Participants will be put into different groups, and each group will receive a specific treatment – either lutikizumab or adalimumab. Doctors will closely follow everyone's progress over several weeks, checking symptoms and overall health. Some people might continue with the study for longer if their treatment is working well.

Key takeaways

A new medicine, lutikizumab, is being studied for ulcerative colitis.
It's compared to an existing treatment, adalimumab.
The study looks at safety and how well the treatment works.
Participants will have regular clinic visits and health checks.
Your involvement helps improve future treatments for UC.
You can leave the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or over and have been diagnosed with ulcerative colitis for at least three months. Your UC needs to be moderate to severe, meaning your symptoms are active and noticeable.

You should also have tried at least one other UC treatment, such as aminosalicylates, steroids, or other strong medicines, and found that they either didn't work well enough, stopped working, or caused side effects that you couldn't tolerate.

However, you cannot join if you have Crohn's disease, or if your UC only affects the very last part of your bowel (rectum). Also, if adalimumab hasn't worked for you in the past, or you had bad side effects from it, you won't be able to take part in this 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 an adult (18 years or older)?
Have you been diagnosed with ulcerative colitis for at least 3 months?
Is your ulcerative colitis moderate to severe and active?
Have you tried other UC medicines that didn't work well or caused problems?
Have you NOT had a bad reaction or no success with adalimumab before?
Do you NOT have Crohn's disease or UC only affecting your rectum?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several regular visits to a hospital or clinic. During these visits, doctors and nurses will check your health with medical exams, blood tests, and ask you to fill out questionnaires about how you're feeling and your symptoms. They will also keep a close eye on any side effects you might experience.

For the first 12 weeks (the 'Induction Period'), you will receive either lutikizumab (given directly into a vein or as an injection under the skin) or adalimumab (an injection under the skin). After these 12 weeks, if your treatment has helped, you might continue with lutikizumab injections at different times, or continue with adalimumab if you are in that group. If your initial treatment didn't work, you might be switched to lutikizumab.

Some participants who benefit from the study medicine at 52 weeks might have the option to continue in an extra, longer-term part of the study for another year. There will be more appointments involved than your usual care, but this helps the study team understand the treatment fully.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available, and close monitoring of your health by a specialist team. Your involvement also helps advance medical knowledge for others with ulcerative colitis. However, there are potential risks, including side effects from the study medication, which may be unknown or severe. The treatment might not work for you, and there will be more doctor visits and tests than usual. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (191)

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

Gastro SB /ID# 258331
Verified postcode
Chula Vista, United States
Southern California Res. Ctr. /ID# 258391
Verified postcode
Coronado, United States
Newport Huntington Medical Group /ID# 258371
Verified postcode
Huntington Beach, United States
Om Research LLC /ID# 261383
Verified postcode
Lancaster, United States
UC Irvine Health /ID# 259824
Verified postcode
Orange, United States
University of Colorado Hospital /ID# 258388
Verified postcode
Aurora, United States
Research Associates of South Florida, LLC /ID# 259813
Verified postcode
Coral Gables, United States
University of Florida College of Medicine /ID# 260402
Verified postcode
Gainesville, United States
Auzmer Research /ID# 260940
Verified postcode
Lakeland, United States
Atlantic Medical Research /ID# 258507
Verified postcode
Margate, United States
Homestead Associates in Research /ID# 260392
Verified postcode
Miami, United States
University of Miami /ID# 258396
Verified postcode
Miami, United States

Common questions

What is ulcerative colitis?

It's a long-term condition that causes inflammation and sometimes bleeding in the inner lining of your large bowel (colon and rectum).

What is lutikizumab?

It's a new investigational medicine being tested for its ability to treat moderate to severe ulcerative colitis.

What is adalimumab?

Adalimumab is an existing medicine already used to treat ulcerative colitis and other inflammatory conditions.

How will I know which treatment I'm getting?

Participants are randomly assigned to a treatment group, meaning it's chosen by chance, like flipping a coin. You might not know which specific treatment you are receiving until later.

How long will the study last for me?

The initial part of the study lasts 52 weeks. If your treatment is working well, you might be invited to join an optional follow-up study for another 52 weeks.