Active not recruitingPHASE3INTERVENTIONAL

A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis

This study is testing a new medicine, mirikizumab, for adults who have ulcerative colitis that is moderately to severely active. The main goal is to find out if this medicine can help reduce how often people experience urgent bowel movements. This is for individuals whose ulcerative colitis hasn't responded well to, or they can't tolerate, other common treatments, including biologics. Participants will be in the study for about 36 weeks, which is roughly 8 to 9 months, and the research will involve four different stages. They are looking for people diagnosed with ulcerative colitis for at least three months who are currently experiencing bowel urgency.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

172

Start

17 May 2023

Estimated completion

01 Apr 2026

Ulcerative Colitis Ulcerative Colitis Chronic

Results

Results from this study

Posted September 2025

Results have been published for this study.

Primary outcome

Change From Baseline in Bowel Urgency Severity Urgency Numeric Rating Scale (UNRS)

The UNRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Baseline Observation Carried Forward (BOCF) endpoint was defined as the baseline value for participants discontinued during acute phase and defined as the last non-missing observation in the treatment phase for all other randomized participants.

Full results on the registry

What is this study about?

This research study is investigating a new medication called mirikizumab (its study code is LY3074828) for adults living with ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation and sores in the lining of the large intestine. Many people with ulcerative colitis experience frequent and urgent bowel movements, which can significantly affect their daily lives.

The main aim of this study is to see how well mirikizumab works in reducing bowell urgency for people whose ulcerative colitis is moderately to severely active. This is particularly important for those who haven't found relief, have stopped responding to, or couldn't take other common treatments, including certain biologic medicines or other types of therapies for ulcerative colitis.

By taking part, you would be helping doctors and researchers understand if mirikizumab could be a new and effective treatment option to improve symptoms, especially bowel urgency, for those living with this condition. The study will run for about 36 weeks, allowing researchers to carefully observe the effects of the new medicine.

Key takeaways

This study is for adults with moderate to severe ulcerative colitis.
It tests a new medicine, mirikizumab, for reducing bowel urgency.
It's for people whose past treatments haven't worked or weren't tolerated.
The study lasts about 36 weeks and involves regular clinic visits.
Participation is voluntary, and you can leave at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. You need to have been diagnosed with ulcerative colitis for at least three months, and your condition should currently be moderate to severe. Importantly, you must be experiencing urgent bowel movements and have found that other treatments for your ulcerative colitis haven't worked well, have stopped working, or you couldn't tolerate them.

However, there are some reasons why you might not be able to join. For example, if you have Crohn's disease, or a related condition called inflammatory bowel disease-unclassified. Also, if your ulcerative colitis is only in the very first part of your large intestine (up to about 10-15 cm from the anus), you wouldn't be able to participate.

You also can't join if you have certain other serious health issues, such as a history of gut cancer, active tuberculosis, HIV infection, or some rare inherited immune conditions. The study team will review your full medical history to confirm if you are suitable.

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 diagnosis of ulcerative colitis for at least 3 months?
Is your ulcerative colitis currently moderate to severe?
Do you experience urgent bowel movements?
Have other ulcerative colitis treatments not worked well for you, or did you stop responding or couldn't tolerate them?
Do you have Crohn's disease or only very mild colitis in just the lowest part of your rectum?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve several visits to the clinic over approximately 36 weeks (about 8 months). During these visits, the study team will carry out various assessments. These might include physical examinations, blood tests, and checking your symptoms, especially your bowel urgency. You will be given the study medication, mirikizumab, to take as directed. Throughout the study, the team will closely monitor your health and how you are responding to the treatment. After the main treatment period, there will be a follow-up period to ensure your well-being. The study team will explain everything in detail, including the exact schedule of visits and what each visit will involve.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to a new treatment that might improve your bowel urgency and ulcerative colitis symptoms, especially if other treatments haven't helped. However, there are also potential risks; for instance, mirikizumab might cause side effects, some of which could be serious, although the study team will monitor you closely for any issues. There's also no guarantee that the treatment will work for everyone. It's important to remember that participating 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 (120)

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

Dedicated Clinical Research
Verified postcode
Litchfield Park, United States
Arizona Digestive Health - Sun City
Verified postcode
Sun City, United States
Om Research, LLC
Verified postcode
Lancaster, United States
California Medical Research Associates, Inc.
Verified postcode
Northridge, United States
Clinical Applications Laboratories, Inc.
Verified postcode
San Diego, United States
Medical Research Center of Connecticut, LLC
Verified postcode
Hamden, United States
Central Florida Gastro Research
Verified postcode
Clearwater, United States
Encore Borland-Groover Clinical Research
Verified postcode
Jacksonville, United States
Research Associates of South Florida
Verified postcode
Miami, United States
Advanced Research Associates, LLC
Verified postcode
Miami, United States
GCP Clinical Research, LLC
Verified postcode
Tampa, United States
International Center for Research LLC
Verified postcode
Tampa, United States

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops small sores, leading to symptoms like urgent bowel movements.

What is 'bowel urgency'?

Bowel urgency means having a sudden, strong, and often uncontrollable need to empty your bowels.

What does 'moderately to severely active' colitis mean?

This means your ulcerative colitis symptoms are ongoing and noticeable, significantly impacting your daily life, and are not just mild.

What is 'mirikizumab'?

Mirikizumab is an investigational medicine being tested in this study to see if it can help treat ulcerative colitis and reduce bowel urgency.

How long will I be in the study if I join?

The study will last for about 36 weeks, which is roughly 8 to 9 months, including treatment and follow-up periods.