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Comparing mirikizumab versus azathioprine with glucocorticoids in newly diagnosed patients with moderate-to-severe 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 focuses on patients with ulcerative colitis, a condition that causes inflammation and sores in the digestive tract. The research compares two different treatment approaches for people newly diagnosed with moderate to severe forms of this disease who have not responded well enough to previous treatments.

The study evaluates two treatment options. The first treatment uses mirikizumab, a new type of medicine that is given either as an injection under the skin or through an intravenous infusion. The second treatment approach uses a combination of azathioprine (a medication that reduces immune system activity) and glucocorticoids (anti-inflammatory medications taken by mouth). The purpose is to determine if mirikizumab is more effective than the standard treatment with azathioprine and glucocorticoids in controlling the disease.

The treatment period lasts for 52 weeks (one year). During this time, patients will receive either mirikizumab or the combination of azathioprine and glucocorticoids, depending on which treatment group they are assigned to. Throughout the study, doctors will monitor how well the treatments are working and how they affect the patients' condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will be randomly assigned to one of two treatment groups: either mirikizumab or azathioprine with glucocorticoids

    If you are in the mirikizumab group, you will receive the medication through subcutaneous injection (under the skin)

    If you are in the azathioprine group, you will take the medication orally (by mouth) along with glucocorticoids

  2. Step 2

    Ongoing treatment and monitoring

    Your treatment will continue for 52 weeks (one year)

    Regular assessments will include blood tests and stool samples

    You will need to complete a daily diary to track your condition

    You will undergo periodic endoscopy procedures (examination of the intestine using a small camera)

  3. Step 3

    Medication requirements

    If you are currently taking 5-ASA medication, you must have been on it for at least 8 weeks, with a stable dose for 2 weeks before starting the trial

    If you are taking oral steroids, the dose must be stable for at least two weeks before starting, with prednisone not exceeding 20 mg per day (or equivalent)

  4. Step 4

    Final evaluation

    At week 52, your condition will be evaluated to determine if you have achieved comprehensive disease control

    The evaluation will include assessment of your symptoms, endoscopy results, and overall disease activity

Who can join the trial?

14 criteria

  • Must be between 18 and 75 years old
  • Must provide written informed consent before any study procedures begin
  • Must have been diagnosed with ulcerative colitis within the last 12 months
  • Must have disease affecting at least the rectum and sigmoid colon (more than 15 cm of the lower intestine)
  • Must have been taking 5-ASA medication (a type of anti-inflammatory drug) for at least 8 weeks, with a stable dose for at least 2 weeks before starting the study
  • Must have a Modified Mayo Score (a measure of disease activity) between 5 and 9
  • Must have an Endoscopic Mayo Score (a measure of how the colon looks during examination) of 2 or higher
  • Must have a Robarts Histopathology Index (a measure of inflammation in tissue samples) greater than 4
  • Must have elevated levels of CRP (a blood marker of inflammation) or Fecal Calprotectin (a stool marker of inflammation) above 250 μg/g
  • Must never have received azathioprine or 6-MP (types of immunosuppressive medications)
  • Must never have received advanced therapies for ulcerative colitis
  • Must be willing to complete all study assessments, including endoscopy procedures and daily diary entries
  • Must agree to follow contraception requirements during the study
  • If taking oral steroids, the dose must be stable for at least two weeks before starting the study and not exceed 20 mg per day of prednisone (or equivalent)

Who cannot join the trial?

15 criteria

  • History of inflammatory bowel disease (IBD) other than ulcerative colitis
  • Previous treatment with any biological therapy (medications that target specific proteins in the immune system)
  • Active or latent tuberculosis
  • History of cancer in the past 5 years, except for successfully treated non-melanoma skin cancer
  • Serious infections requiring hospitalization or IV antibiotics within the last 3 months
  • Current or recent opportunistic infections (infections that occur more frequently in people with weakened immune systems)
  • Hepatitis B or hepatitis C infection
  • Significant heart, lung, kidney, or liver disease
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within the past 30 days
  • Known allergies to study medications or their components
  • Mental conditions that could interfere with study participation
  • Substance abuse within the past year
  • Unable to provide informed consent
  • Age below 18 or above 65 years
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Investigated drugs

  • Mirikizumab

    is a biological medication that targets specific proteins in the body to reduce inflammation in ulcerative colitis. It is administered through injections and works by blocking certain inflammatory pathways that contribute to the symptoms of ulcerative colitis.

  • Azathioprine

    is an immunosuppressive medication that helps control the immune system's response. It is taken orally and works by reducing inflammation in the digestive tract. It is commonly used as a standard treatment for ulcerative colitis.

  • Glucocorticoids

    are anti-inflammatory medications that help reduce inflammation throughout the body. They work by suppressing the immune system's response and can quickly improve symptoms of ulcerative colitis. These medications can be taken orally or administered through other methods depending on the specific treatment plan.

What is already known about the treatment

  • Mirikizumab

    A novel biological medication administered through subcutaneous injection that targets the IL-23 pathway in inflammatory conditions. This monoclonal antibody is currently being investigated in clinical trials for treating moderate to severe ulcerative colitis, representing a promising top-down therapy approach. The medication works by selectively binding to the p19 subunit of interleukin-23, thereby reducing inflammation in the digestive tract and potentially leading to better disease control than traditional treatments.

  • Azathioprine

    An oral immunosuppressive medication that belongs to the thiopurine class of drugs, commonly used as a standard treatment for ulcerative colitis. This medication works by interfering with DNA synthesis in immune cells, thereby reducing inflammation in the intestinal tract and helping to maintain remission in inflammatory bowel disease. It is typically prescribed alongside glucocorticoids as part of a conventional step-up treatment approach, with effectiveness usually becoming apparent after several weeks of consistent use.

Investigated diseases

Ulcerative Colitis - A chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, primarily affecting the innermost lining of the large intestine and rectum. The condition typically develops over time, with symptoms that can include abdominal pain, diarrhea, rectal bleeding, and fatigue. The inflammation usually begins in the rectum and can spread continuously to other parts of the colon. The disease can alternate between periods of active symptoms (flares) and periods of remission with no symptoms. The exact cause is unknown, but it's believed to involve an abnormal immune response, genetic factors, and environmental triggers.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522585-72-00Protocol codeMIRACLEEstimated enrolment300 patientsSponsorUniversitaetsklinikum Schleswig-Holstein AöR

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).