Comparing mirikizumab versus azathioprine with glucocorticoids in newly diagnosed patients with moderate-to-severe ulcerative colitis

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Staedtisches Klinikum Lueneburg gGmbH Lueneburg Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Klinikum Ernst von Bergmann gGmbH Potsdam Germany
Siloah St Trudpert Klinikum Pforzheim Germany
Philipps-Universitaet Marburg Marburg Germany
Specialist Internal Medicine Practice Hamburg Germany
Surgery Dr. med. Thomas Zeisler Halle (Saale) Germany
Gastropraxis an der St. Barbara-Klinik Hamm Germany
Gemeinschaftspraxis Dres. Denger & Pfitzner Friedrichsthal Germany
Praxisgemeinschaft am Offerbusch Velbert Germany
Studienzentrum Dres. Glas/ Gürtler Leipzig Germany
MVZ Gastroenterologie und Innere Medizin Iserlohn Iserlohn Germany
Mmacfsdcccztrsppxuhznyygaf Hnmmwgyqrdnopwzj Halle (Saale) Germany
Gploedpaohrxlucddapn Scacggpoztihdelvd Ptrkh Dfd Llrqhl &maxn Dcj mppm Ggvgxe Dornstadt Germany
Pxjqueeo fbb Gckkpldejtordgaz Hanover Germany
Sadnyjldyvhyrqrjvzh Bdj Uu (gjqbwylyploppxvhupba Halle (Saale) Germany
Gkupykhvryrpimajd Owxwyceihkh Kassel Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Recruiting
01.09.2025

Trial locations

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.

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 ID:
2025-522585-72-00
Protocol code:
MIRACLE
Trial Phase:
Therapeutic confirmatory (Phase III)

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