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

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 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.

The research process

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

Step 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.
Step 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.
Step 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.
Step 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 trial?

11 criteria

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)
check
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 trial?

14 criteria

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

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Verified sites

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Verified
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Responsive
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Belgium
Responsive
Soedersjukhuset AB
Stockholm, Sweden

Trial locations

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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.

Risankizumab

What is already known about the treatment

Risankizumab – A biologic medication administered through subcutaneous injection that belongs to the class of interleukin-23 (IL-23) inhibitors used in the treatment of inflammatory conditions. This medication works by targeting and blocking IL-23, a protein involved in causing inflammation in the body, particularly effective in treating autoimmune conditions such as ulcerative colitis. Currently undergoing clinical trials for pediatric patients with moderately to severely active ulcerative colitis, risankizumab has shown promising results in reducing inflammation in the digestive tract and managing symptoms of the disease. The drug is being evaluated for its effectiveness and safety in children aged 2 to 18 years, representing an important potential treatment option for young patients with this challenging inflammatory bowel condition.

Investigated diseases

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.