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Study on Crohn's Disease: Evaluating Risankizumab's Effects in Children Aged 2 to 17 with Moderate to Severe Symptoms

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What is this trial about?

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

This clinical trial is focused on studying Crohn's disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study is investigating the effects of a treatment called Risankizumab, which is a medication designed to help reduce inflammation and improve symptoms in patients with this disease. The medication is administered either as a solution for infusion, which means it is given directly into the bloodstream through a vein, or as a solution for injection using a pre-filled syringe, which is injected under the skin.

The purpose of this study is to evaluate how Risankizumab is processed in the body, its effectiveness, and its safety in children and teenagers aged 2 to under 18 years who have moderate to severe Crohn's disease. The study will begin with an open-label phase, where all participants receive the medication, followed by a randomized double-blind phase, where participants will receive either the medication or a placebo without knowing which one they are getting. There will also be a long-term extension period to observe the effects over a longer time. Participants will be monitored for changes in their symptoms and any side effects they may experience.

The study is designed to last for several weeks, with regular check-ups and assessments to track the progress of the participants. The goal is to determine if Risankizumab can help achieve clinical remission, which means a significant reduction or disappearance of symptoms, and to see if it can lead to an endoscopic response, which is an improvement in the appearance of the digestive tract as seen through a camera. The study will also look at whether participants can achieve remission without the use of corticosteroids, which are often used to control inflammation but can have side effects when used long-term.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Open-label induction period

    Upon joining the study, the participant will begin the open-label induction period. During this phase, the participant will receive risankizumab through an intravenous infusion. This is a method where the medication is delivered directly into the bloodstream through a vein.

    The purpose of this phase is to introduce the medication to the participant's system and to monitor its initial effects. The specific dosage and frequency of administration will be determined by the study team based on the participant's individual needs and health status.

  2. Step 2

    Randomized double-blind maintenance period

    Following the induction period, the participant will enter the randomized double-blind maintenance period. In this phase, the participant will receive either risankizumab or a placebo through a subcutaneous injection. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

    Neither the participant nor the study team will know whether the participant is receiving the medication or the placebo. This is to ensure that the results are not influenced by expectations. The injections will be administered at regular intervals as specified by the study protocol.

  3. Step 3

    Long-term extension period

    After completing the maintenance period, the participant may enter the long-term extension period. This phase allows for continued monitoring and treatment with risankizumab for those who qualify.

    The goal of this period is to assess the long-term effects and safety of the medication. The participant will continue to receive the medication through subcutaneous injections at intervals determined by the study team.

Who can join the trial?

18 criteria

  • The patient or their legal representative must sign a consent form to participate in the study.
  • The patient must weigh at least 10 kilograms (about 22 pounds) at the start of the study.
  • The patient must have certain blood test results within specific ranges, including:
    • Serum ALT (a liver enzyme) must be less than or equal to 2 times the upper limit of normal.
    • Serum AST (another liver enzyme) must be less than or equal to 2 times the upper limit of normal.
    • Serum total bilirubin (a substance made by the liver) must be less than 2 mg/dL, except for those with a condition called Gilbert syndrome.
    • Total white blood cell count must be at least 3,000 per microliter.
    • Absolute neutrophil count (a type of white blood cell) must be at least 1,500 per microliter.
    • Platelet count (cells that help with blood clotting) must be at least 100,000 per microliter.
    • Hemoglobin (a protein in red blood cells) must be at least 8 grams per deciliter.
    • The patient must have a confirmed diagnosis of Crohn's disease for at least 3 months before starting the study.
    • The patient must have moderately to severely active Crohn's disease, as determined by a specific score called the PCDAI score.
    • The patient must have evidence of inflammation in the intestines, as shown by an endoscopy score called the SES-CD.
    • The patient must have shown intolerance or inadequate response to certain medications used to treat Crohn's disease.
    • The patient must be in good general health, as determined by a doctor based on medical history, physical examination, and tests.
    • If the patient has had Crohn's disease involving the colon for more than 9 years, they must have had a recent colonoscopy showing no signs of abnormal cell growth.
    • Females who can become pregnant must have a negative pregnancy test before starting the study and use at least one method of birth control during the study and for a period after the study ends.
    • The patient must be willing and able to follow the study procedures.
    • The patient must be between 2 and 18 years old. If they turn 18 during the study, they can continue to participate.

Who cannot join the trial?

10 criteria

  • Patients who have a known allergy or reaction to the study medication cannot participate.
  • Patients with a history of certain serious infections, such as tuberculosis, cannot participate.
  • Patients who have recently received certain vaccines, especially live vaccines, may not be eligible.
  • Patients with certain types of cancer or a history of cancer may not be eligible.
  • Patients with severe liver or kidney disease cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial may not be eligible.
  • Patients with certain heart conditions may not be eligible.
  • Patients who have had a recent surgery or are planning to have surgery soon may not be eligible.
  • Patients with a history of drug or alcohol abuse may not be eligible.
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Investigated drugs

Risankizumab is a medication being studied for its potential to help children and teenagers with Crohn's disease, which is a condition that causes inflammation in the digestive tract. This medication works by targeting a specific protein in the body that is involved in the inflammation process. By blocking this protein, risankizumab may help reduce the symptoms of Crohn's disease, such as stomach pain and diarrhea, and improve the overall health of the digestive system. The study aims to understand how the body processes this medication, how effective it is in treating the disease, and how safe it is for young patients to use.

What is already known about the treatment

Risankizumab – Risankizumab is administered as an injection under the skin, typically given by a healthcare professional. It is currently being studied in clinical trials for its effectiveness and safety in treating children with moderate to severe Crohn's disease, a condition that causes inflammation in the digestive tract. The medication works by targeting a specific protein in the body that plays a role in inflammation, helping to reduce symptoms and improve quality of life. Risankizumab is classified as a monoclonal antibody, a type of drug designed to interact with the immune system to help control inflammation.

Investigated diseases

Crohn's disease – Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of active disease, known as flare-ups, and periods of remission. During flare-ups, individuals may experience symptoms such as abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can affect different layers of the bowel wall and may lead to complications like strictures or fistulas. The disease can progress over time, with symptoms varying in severity and frequency. The exact cause of Crohn's disease is unknown, but it involves an abnormal immune response to intestinal bacteria in genetically susceptible individuals.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2022-502050-14-00Protocol codeM16-194Estimated enrolment118 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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