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Study on Bowel Urgency in Adults with Moderate to Severe Ulcerative Colitis Treated with Mirikizumab

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying ulcerative colitis, a condition that causes inflammation and sores in the digestive tract, specifically affecting the colon and rectum. The study is investigating the effects of a treatment called Mirikizumab, which is administered as a solution for injection. Mirikizumab is a type of protein-based medication developed by Eli Lilly and Company.

The purpose of the study is to assess how well Mirikizumab can improve the severity of bowel urgency, which is a common and distressing symptom for people with moderately to severely active ulcerative colitis. Participants in the study will receive Mirikizumab and will be monitored over a period of 12 weeks to observe any changes in their symptoms.

This study is designed to provide valuable insights into the relationship between bowel urgency and other health outcomes in adults with ulcerative colitis. By the end of the study, researchers aim to better understand how Mirikizumab can help manage this condition and improve the quality of life for those affected.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. This study aims to investigate the improvement in bowel urgency in adults with moderately to severely active ulcerative colitis using mirikizumab.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying your diagnosis of ulcerative colitis and ensuring you meet the criteria for participation.

  3. Step 3

    Treatment administration

    You will receive mirikizumab as a solution for injection. The dosage and frequency will be explained to you by the medical team. The treatment will continue for a specified duration, with regular monitoring.

  4. Step 4

    Regular monitoring

    Throughout the study, you will have regular check-ups to monitor your condition and any changes in bowel urgency. These assessments will help track your progress and any side effects.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the change in bowel urgency severity. This will help determine the effectiveness of the treatment.

Who can join the trial?

6 criteria

  • Have an established diagnosis of Ulcerative Colitis (UC) for at least 3 months.
  • Have a confirmed diagnosis of moderately to severely active Ulcerative Colitis.
  • Have current bowel urgency (a strong need to have a bowel movement).
  • Have shown an inadequate response to, a loss of response to, or an intolerance to conventional treatments or to biologic/Janus Kinase (JAK) inhibitor/sphingosine-1-phosphate (S1P) receptor modulator therapy for Ulcerative Colitis.
  • Be within the age range of 18 to 65 years old.
  • Both male and female participants are eligible.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had recent surgery related to the digestive system.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of not following medical advice or treatment plans.
  • Patients with a known allergy to the study medication or its ingredients.
  • Patients with a history of alcohol or drug abuse.
  • Patients who have been diagnosed with certain infections that could affect the study.
  • Patients who have received certain treatments that could interfere with the study results.
  • Patients with a history of certain types of cancer.
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Investigated drugs

Mirikizumab is a medication being studied for its effects on ulcerative colitis, which is a condition that causes inflammation and sores in the colon and rectum. This medication works by targeting a specific protein in the body that is involved in the inflammatory process. By blocking this protein, Mirikizumab aims to reduce inflammation and help improve symptoms such as bowel urgency, which is a sudden and strong need to have a bowel movement. The goal of using Mirikizumab in this trial is to see if it can help people with moderately to severely active ulcerative colitis feel better by reducing the severity of their symptoms.

What is already known about the treatment

Mirikizumab – Mirikizumab is administered as an injection, typically under the skin, and is currently being studied for its effectiveness in treating moderately to severely active ulcerative colitis, a condition that causes inflammation and sores in the colon. In medical literature, it is being explored for its potential to reduce symptoms like bowel urgency. The medication works by targeting and blocking a specific protein in the body that contributes to inflammation, helping to reduce the symptoms of the disease. It is classified as a monoclonal antibody, which is a type of drug designed to interact with specific targets in the immune system.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon, also known as the large intestine. It is characterized by inflammation and ulceration of the innermost lining of the colon, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease typically begins in the rectum and may extend continuously to involve the entire colon. The inflammation causes the colon to empty frequently, resulting in urgent bowel movements. Over time, the persistent inflammation can lead to the formation of ulcers, which are small open sores that can bleed and produce pus. The severity of symptoms can vary, with periods of active disease followed by times of remission.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502393-16-00Protocol codeI6T-MC-AMBZEstimated enrolment173 patientsSponsorEli Lilly & Co.

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