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A study of LY4268989 and mirikizumab in adults with moderately to severely active ulcerative colitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study investigates treatments for Ulcerative Colitis, a condition characterized by long-lasting inflammation and sores in the lining of the large intestine. The purpose of the study is to evaluate the effectiveness of combining two different medicines compared to using just one. The medications being studied include mirikizumab, which is given through intravenous injection (delivered directly into a vein) or subcutaneous injection (delivered just under the skin), and LY4268989, which is an oral capsule. Some participants may also receive a placebo.

During the study, participants will be assigned to different groups to receive either the combination of LY4268989 and mirikizumab or mirikizumab alone. The process is double-blind, meaning neither the participants nor the researchers know which specific treatment is being administered. The course of the study involves monitoring the participants over a 12-week period to observe how they respond to the medications.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The induction phase begins with the administration of mirikizumab. this is an intravenous injection, meaning it is delivered directly into a vein, at a dose of 300 mg.
During this period, the mirikizumab is administered to help manage ulcerative colitis, which is an inflammatory condition of the large intestine.
Step 2
Combination or single therapy administration
The treatment involves either mirikizumab alone or mirikizumab combined with LY4268989 (also known as MORF-057).
LY4268989 is taken as an oral capsule.
One group receives the test medication, while another group receives a placebo, which is an inactive substance used for comparison.
Step 3
Maintenance and monitoring
Following the initial stage, mirikizumab is administered via subcutaneous use, which is an injection under the skin, at a dose of 200 mg.
The total duration for evaluating the effectiveness of the induction phase is 12 weeks.
The progress is monitored to determine if clinical remission, a state where symptoms of the disease are significantly reduced or absent, is achieved by the 12-week mark.

Who can join the trial?

7 criteria

You must have been diagnosed with Ulcerative Colitis, which is a condition that causes long-term inflammation and sores in the lining of your large intestine, for at least 3 months before starting the study.
Your Ulcerative Colitis must be moderately to severely active, meaning your symptoms are significant and currently causing noticeable issues.
The inflammation from your Ulcerative Colitis must extend proximal to the rectum, which means the affected area is located further up in the large intestine, beyond the rectum.
If you have had symptoms of Ulcerative Colitis for more than 8 years, you must have had a surveillance colonoscopy (a procedure where a doctor uses a camera to look inside the colon) within the last year, or according to your local medical rules, to check for polyps (small growths on the colon lining), dysplasia (abnormal cell changes that could lead to cancer), or malignancy (cancer).
You must be up-to-date with all required colorectal cancer surveillance, which refers to regular medical check-ups and screenings to look for signs of cancer in the large intestine.
You must have had an inadequate response (the medicine did not work well enough), a loss of response (the medicine used to work but stopped working), or an intolerance (you experienced bad side effects) to conventional therapy, immunomodulators (medicines that change how your immune system works), or advanced therapy.
You must be between the ages of 18 and 65 years old.

Who cannot join the trial?

5 criteria

You have a diagnosis of Crohn’s disease, which is a type of long-term swelling in the digestive tract, unclassified inflammatory bowel disease, or primary sclerosing cholangitis, which is a chronic disease that causes inflammation in the bile ducts in your liver.
You have an inherited immunodeficiency syndrome, which is a condition passed down through families that makes your immune system (the body's defense against germs) not work properly, or a known monogenic cause of inflammation that looks like ulcerative colitis.
You have already had, or will need to have, bowel resection, which means a part of your intestine is surgically removed, or any other intestinal or intra-abdominal surgery.
You are likely to need surgery to treat your ulcerative colitis during the time you are in the study.
You have signs of toxic megacolon, which is a severe and dangerous swelling of the colon, an intra-abdominal abscess, which is a pocket of infection inside the belly, or a stricture or stenosis, which are narrowings in your small bowel or colon that make it difficult for a colonoscope (a thin tube with a camera used to look inside the bowel) to pass through or cause symptoms.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Semmelweis University
Budapest, Hungary
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

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Investigated drugs

Mirikizumab
is a medication given by injection into a vein or under the skin to help treat people with moderately to severely active ulcerative colitis, an inflammatory bowel disease.
LY4268989
is an experimental medication taken in capsule form by mouth that is being studied for its ability to be used alongside Mirikizumab to treat ulcerative colitis.

What is already known about the treatment

Mirikizumab
This medication is an injectable solution that can be administered either through a vein or under the skin. It is currently being studied for its ability to treat moderately to severely active ulcerative colitis, an inflammatory bowel disease. As a specialized biological therapy, it works by targeting and blocking a specific protein in the body that triggers inflammation. By stopping this protein, the drug helps reduce the swelling and irritation in the digestive tract.
LY4268989
This substance is an oral medication provided in capsule form. It is an experimental compound currently under investigation for its potential to help manage ulcerative colitis. It functions by acting on specific molecules within the body to help control the inflammatory processes associated with the disease. This drug is classified as a small molecule therapeutic and is being studied for its ability to work alongside other treatments.

Investigated diseases

Ulcerative Colitis - This is a condition that causes inflammation and sores in the lining of the large intestine and rectum. The inflammation typically starts in the rectum and can spread upward through the rest of the colon. As the disease progresses, the swelling in the intestinal wall can lead to frequent changes in bowel habits. The condition often involves periods of active inflammation followed by periods of calm. It is a chronic condition that affects the digestive system.