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A study testing how well mirikizumab works to achieve transmural healing in patients with Crohn's Disease

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This study examines Crohn's Disease, which is a long-term condition that causes inflammation and irritation in the digestive system, leading to symptoms such as abdominal pain, diarrhea, and bowel urgency. The treatment being studied is mirikizumab, also known by its code name LY-3074828, which is marketed as Omvoh. This medication is given either as an injection under the skin using a pre-filled pen or syringe, or as an infusion into a vein. The purpose of this study is to describe how well mirikizumab therapy works to achieve transmural response in patients with Crohn's Disease, which means reducing inflammation through all layers of the intestinal wall.

During the study, patients will receive mirikizumab treatment over a period of up to 15 months for the injection forms and 3 months for the infusion form. The study will use imaging techniques such as MRI, which stands for magnetic resonance imaging and creates detailed pictures of the inside of the body, to measure changes in intestinal inflammation. Doctors will assess transmural response by looking at whether there is at least a 25% decrease in inflammation scores in affected segments of the intestine from the start of the study to week 24. The study will also evaluate whether patients achieve clinical remission, which means their symptoms have significantly improved or disappeared, and whether this improvement occurs together with the reduction in intestinal wall inflammation.

Throughout the study, researchers will monitor various aspects of the disease and treatment response at different time points including weeks 4, 8, 12, and 24. They will assess bowel damage, clinical symptoms, biochemical markers in the blood, and how well patients tolerate the medication. The study will also evaluate quality of life measures and track any unwanted effects or serious unwanted effects that may occur during treatment. Additional imaging with ultrasound may be used at certain visits to check for changes in intestinal inflammation.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase with intravenous infusion

    The treatment begins with receiving mirikizumab through an intravenous infusion, which means the medication is delivered directly into a vein through a drip. The dosage used is 300 mg.

    This initial phase establishes the medication in the body to begin addressing the inflammation in the intestines.

  2. Step 2

    Transition to self-administered injections

    After the initial infusion, the treatment continues with subcutaneous injections, which means injections given under the skin. These injections can be administered at home using pre-filled devices.

    Two types of injection devices are available: pre-filled pens and pre-filled syringes. The dosages used are 100 mg or 200 mg, or a combination of 100 mg plus 200 mg, depending on the treatment plan.

    The injections are given at regular intervals as determined by the study protocol to maintain consistent medication levels in the body.

  3. Step 3

    Assessment at week 4

    At 4 weeks after starting treatment, an evaluation takes place to assess how the body is responding to the medication.

    This includes checking for improvements in symptoms such as abdominal pain and bowel frequency, as well as measuring inflammation markers in blood tests.

    An ultrasound examination of the intestines may be performed to evaluate changes in inflammation through the bowel wall.

  4. Step 4

    Assessment at week 8

    At 8 weeks, another evaluation is conducted to monitor progress.

    Similar assessments are performed, including symptom evaluation, blood tests to check inflammation levels, and potentially an ultrasound examination of the intestines.

    The frequency and urgency of bowel movements are also assessed.

  5. Step 5

    Assessment at week 12

    At 12 weeks (3 months), further evaluation takes place to determine treatment effectiveness.

    This includes checking symptom improvement, blood test results for inflammation markers, and potentially an ultrasound examination.

    Quality of life and daily functioning are also evaluated through questionnaires.

  6. Step 6

    Major assessment at week 24 (6 months)

    At 24 weeks (6 months), a comprehensive evaluation is performed, which represents a key milestone in the study.

    An MRI scan (magnetic resonance imaging) is performed to assess inflammation through the entire thickness of the bowel wall. The MRI measures a C-score, which is a numerical value indicating the level of inflammation in each affected bowel segment.

    The primary goal is to achieve at least a 25% reduction in the C-score in all affected bowel segments compared to the start of the study.

    Symptom assessment is conducted, including evaluation of abdominal pain, bowel frequency, and bowel urgency using specific scoring systems.

    Blood tests are performed to measure inflammation markers and assess biochemical remission.

    Ultrasound examination of the intestines may also be performed.

    Quality of life is assessed using the Inflammatory Bowel Disease Questionnaire, and the impact on daily activities is measured using the Inflammatory Bowel Disease Disability Index.

    An acceptability scale is used to evaluate satisfaction with the treatment.

    Any side effects or adverse events experienced during the treatment are documented.

  7. Step 7

    Continued treatment and monitoring until month 18

    Treatment with mirikizumab continues with regular subcutaneous injections after the 6-month assessment.

    Ongoing monitoring includes regular check-ups to assess symptom control, blood tests, and evaluation of any side effects.

    At 18 months, another comprehensive assessment is performed, including evaluation of any structural changes or damage to the bowel using the Lemann Index, which measures long-term bowel damage.

    An MRI scan may be repeated to assess the current state of inflammation and healing in the bowel wall.

  8. Step 8

    Long-term follow-up

    The study continues with ongoing treatment and monitoring to evaluate the long-term effectiveness and safety of mirikizumab in managing Crohn's disease.

    Regular assessments continue to track symptom control, inflammation levels, quality of life, and any adverse events.

    The ability to continue taking the medication without interruption (drug retention) is also monitored throughout the study period.

Who can join the trial?

4 criteria

  • You must have Crohn's Disease, which is a condition that causes inflammation in parts of the digestive system
  • You must be at least 18 years old and not older than 75 years old
  • You must have symptoms of Crohn's Disease shown by having either more than 3 bowel movements per day or abdominal pain with a score higher than 1, which means you experience belly pain
  • You must have transmural inflammation, which means inflammation that goes through all layers of the intestinal wall, confirmed by an MRI scan (a type of imaging test) at the start of the study, with a score greater than 0.5 in at least one part of your intestine

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in this study
  • Without detailed exclusion criteria listed, it is not possible to specify which medical conditions, medications, or other factors would prevent participation
  • Generally, clinical trials have exclusion criteria to ensure patient safety and accurate study results, but these specific details are not available in the provided information
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Investigated drugs

Mirikizumab is a medication being tested in this clinical trial for people with Crohn's Disease. It is designed to help reduce inflammation in the digestive tract and promote healing through the entire thickness of the intestinal wall, which is called transmural healing.

What is already known about the treatment

Mirikizumab – Mirikizumab is an injectable biological medication administered under the skin or through a vein, currently being studied in clinical trials for treating Crohn's Disease, which is a chronic inflammatory condition of the digestive tract. This medication works by blocking a specific protein called interleukin-23 (IL-23) that plays a key role in causing inflammation in the intestines, helping to reduce swelling and damage to the bowel wall. It belongs to a class of drugs called monoclonal antibodies, which are specially designed proteins that target specific parts of the immune system to control excessive inflammation and promote healing of the intestinal tissues.

Investigated diseases

Crohn's Disease – Crohn's Disease is a chronic inflammatory condition that affects the digestive tract. The inflammation can occur in any part of the gastrointestinal system, from the mouth to the anus, but most commonly affects the end of the small intestine and the beginning of the colon. The disease causes the intestinal wall to become swollen and thickened, which can lead to various digestive problems. Symptoms typically include abdominal pain, diarrhea, fatigue, and weight loss. The condition follows a pattern of flare-ups, where symptoms worsen, followed by periods of remission when symptoms improve or disappear. Over time, the ongoing inflammation can cause damage to the bowel wall and lead to complications such as narrowing of the intestines or the formation of abnormal connections between different parts of the bowel.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521889-95-00Estimated enrolment110 patientsSponsorGroupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

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