Study of risankizumab safety and effectiveness in children and teenagers aged 2-17 years with moderate to severe ulcerative colitis

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What is this study about?

This clinical trial studies the use of risankizumab (also known as ABBV-066) in young patients aged 2 to 18 years who have ulcerative colitis, a condition where the inner lining of the large intestine becomes inflamed and develops small sores or ulcers. The study focuses on patients whose disease is moderately to severely active, meaning their symptoms significantly affect their daily life and have not improved enough with other treatments.

The medication will be given in two different ways: as an intravenous infusion (through a vein) and as a subcutaneous injection (under the skin) using a pre-filled syringe. Some participants will receive the actual medication while others will receive a placebo. The study consists of three main parts: an initial open-label treatment period where all participants receive the medication, followed by a period where participants are randomly assigned to either continue the medication or receive placebo, and finally a long-term extension period.

The purpose of this study is to understand how the medication moves through the body, how well it works, and how safe it is for young patients with ulcerative colitis. The study will measure various aspects of the disease improvement, including the healing of the intestinal lining and the reduction of symptoms such as stomach pain and frequent bowel movements. The total duration of treatment may continue for up to 248 weeks.

1 Initial treatment phase

You will receive risankizumab through an intravenous (IV) infusion (medicine given directly into your vein) during the first treatment phase.

This initial phase lasts for 12 weeks to assess how your body responds to the medication.

During this time, doctors will monitor your condition using a special scoring system called modified Mayo Score that helps measure how active your ulcerative colitis is.

2 Response evaluation

At week 12, your doctor will evaluate if you had a positive response to the treatment.

The evaluation includes checking your symptoms and performing an examination of your colon using a camera (endoscopy).

If you show improvement, you will move to the next phase of the study.

3 Maintenance phase

If you responded well to the initial treatment, you will enter the maintenance phase.

During this phase, you will receive risankizumab as a subcutaneous injection (injection under the skin).

This phase continues until week 64 of the study.

Regular check-ups will monitor your progress and any side effects.

4 Final evaluation

At week 64, doctors will perform a final evaluation of your condition.

This includes checking if your symptoms have improved and performing another endoscopy examination.

If you were taking corticosteroids (a type of anti-inflammatory medication), the doctor will check if you were able to stop using them for at least 90 days while maintaining improvement in your condition.

Who Can Join the Study?

  • Age between 2 and 18 years old
  • Must have active ulcerative colitis with a specific disease activity score (modified Mayo Score between 5-9 points) and visible inflammation in the bowel confirmed by an expert reviewing the endoscopy images
  • Must have had ulcerative colitis for at least 3 months, confirmed by colonoscopy (a procedure where a camera is used to look inside the bowel)
  • Must have tried and not improved with, or had side effects from, at least one of these medications:
    • Aminosalicylates (anti-inflammatory medications)
    • Corticosteroids (medications that reduce inflammation)
    • Immunomodulators (medications that adjust the immune system)
    • Biologic therapies (advanced treatments that target specific parts of the immune system)
  • Must have confirmation from bowel tissue samples that the diagnosis is ulcerative colitis
  • Must not have any current bowel infections
  • Must not have any abnormal cell growth or cancer in the bowel
  • Both male and female patients can participate

Who Cannot Join the Study?

  • History of inflammatory bowel conditions other than ulcerative colitis (conditions causing inflammation in digestive tract)
  • Current or past cancer diagnosis, except for successfully treated non-melanoma skin cancer
  • Active or chronic infections, including tuberculosis (TB), hepatitis B, or hepatitis C
  • Recent live vaccine received within 4 weeks before starting the study
  • Major surgery related to ulcerative colitis in the past 8 weeks
  • Current participation in other clinical trials or use of investigational drugs
  • Serious allergic reactions to similar medications in the past
  • Severe liver disease or abnormal liver function tests
  • Severe kidney disease or significantly reduced kidney function
  • Uncontrolled high blood pressure
  • History of substance abuse within the past year
  • Pregnancy or breastfeeding
  • Mental health conditions that could interfere with study participation
  • Any condition that the study doctor believes would make participation unsafe

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
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo Garofolo Trieste Italy
Hippokration Hospital Athens Greece
Universitaetsklinikum Erlangen AöR Erlangen Germany
Karolinska University Hospital Solna Sweden
Klinikum Kassel GmbH Kassel Germany
University Childrens Hospital Queen Fabiola Brussels Belgium
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Soedersjukhuset AB Stockholm Sweden
Cyntlefdx Uvkqdkrfxnonbf Sjnqqkeyv Woluwe-Saint-Lambert Belgium
Luysl Gnusrer Hxhcmymt Oe Amljpx Athens Greece
Kcvzulxx Wflzfjyvjttpscl Ci Zryegan Pogsttp Potsdam Germany
Uafdutzenkxzyooxchwtx Myndpedi Acr Munster Germany
Hiydcwvo Udvliicgtwfvl di A Cevcww A Coruna Galicia Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
05.09.2025
Germany Germany
Recruiting
05.09.2025
Greece Greece
Recruiting
05.09.2025
Italy Italy
Recruiting
05.09.2025
Spain Spain
Recruiting
05.09.2025
Sweden Sweden
Recruiting
05.09.2025

Trial locations

Investigated drugs:

Risankizumab is a medication that helps treat ulcerative colitis, which is a condition where the large intestine becomes inflamed and develops ulcers. This medication works by targeting specific proteins in the body’s immune system that cause inflammation. It is given as an injection and is designed to reduce inflammation in the intestines, helping to relieve symptoms like diarrhea, abdominal pain, and bleeding in children and teenagers with moderate to severe ulcerative colitis.

Ulcerative Colitis – A chronic inflammatory bowel disease that causes inflammation and sores (ulcers) in the innermost lining of the large intestine (colon) and rectum. The inflammation typically begins in the rectum and spreads upward through the colon, causing continuous damage to the superficial layers of the bowel. The condition usually develops gradually over time and can cause recurring episodes of abdominal pain, diarrhea, bloody stools, and persistent bowel urgency. Ulcerative colitis can affect people of any age, though it often begins during adolescence or young adulthood. The disease tends to have periods of active symptoms (flares) alternating with periods of remission when symptoms subside.

Trial ID:
2024-514695-41-00
Protocol code:
M19-751
Trial Phase:
Therapeutic confirmatory (Phase III)

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