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Study on the Effectiveness of Ozanimod for Children with Moderate to Severe Ulcerative Colitis Not Responding to Usual Treatment

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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 a condition known as ulcerative colitis, which is a chronic disease that causes inflammation and sores in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The study is particularly interested in cases where the disease is moderately to severely active and has not responded well to standard treatments. The treatment being tested in this trial is a medication called Ozanimod, which is taken orally in the form of a hard capsule. Ozanimod is being evaluated for its effectiveness and safety in managing symptoms of ulcerative colitis in children who have not had success with other therapies.

The purpose of the study is to assess how well Ozanimod works in achieving clinical remission, which means reducing the symptoms of ulcerative colitis to a minimal level. Participants in the study will be randomly assigned to receive either Ozanimod or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. The study will take place over a period of time, with regular check-ups to monitor the participants' health and the effects of the treatment. The goal is to see if Ozanimod can help reduce the inflammation and symptoms associated with ulcerative colitis, leading to an improved quality of life for those affected.

Throughout the study, various aspects of the participants' health will be monitored, including the safety and tolerability of Ozanimod. This involves checking for any side effects or adverse reactions to the medication. The study will also look at how the body processes Ozanimod, which is known as pharmacokinetics, and how the drug affects the body, referred to as pharmacodynamics. By the end of the study, researchers hope to gather enough information to determine if Ozanimod is a viable treatment option for children with moderately to severely active ulcerative colitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and a baseline endoscopy to check the extent of ulcerative colitis beyond the rectum.

    Eligibility requires a diagnosis of moderately to severely active ulcerative colitis and an inadequate response to previous treatments such as oral aminosalicylates, systemic corticosteroids, immunomodulators, or biologic therapy.

  2. Step 2

    Randomization and treatment initiation

    Participants are randomly assigned to receive either the study medication, ozanimod, or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

    The medication is taken orally in the form of a hard capsule. The specific dosage and frequency are determined by the study protocol.

  3. Step 3

    Treatment phase

    The treatment phase lasts up to 52 weeks. During this time, participants continue to take the assigned medication as directed.

    Regular visits are scheduled to monitor health, assess the effectiveness of the treatment, and adjust the dosage if necessary.

  4. Step 4

    Evaluation of outcomes

    The primary goal is to achieve clinical remission, which involves improvements in symptoms such as rectal bleeding and stool frequency, as well as endoscopic and histological assessments.

    Secondary outcomes include clinical response, symptomatic improvement, endoscopic improvement, and corticosteroid-free remission.

  5. Step 5

    Safety monitoring

    Throughout the trial, safety is closely monitored. This includes tracking any adverse events or side effects related to the medication.

    Participants may be withdrawn from the study if significant adverse effects occur or if the treatment is not effective.

  6. Step 6

    End of trial

    At the end of the trial, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

    Participants may receive follow-up care as needed based on the outcomes of the trial.

Who can join the trial?

8 criteria

  • The patient must have been diagnosed with moderately to severely active Ulcerative Colitis (UC) before the screening visit. Ulcerative Colitis is a condition that causes inflammation and sores in the colon and rectum.
  • There must be evidence that the UC extends beyond the rectum, which is determined by a procedure called a baseline endoscopy. An endoscopy is a test where a doctor uses a special camera to look inside the digestive tract.
  • The patient should have had an inadequate response, lost response to, or cannot tolerate at least one of the following treatments for UC:
    • Oral aminosalicylates: These are medications taken by mouth to reduce inflammation in the colon.
    • Systemic corticosteroids: These are strong anti-inflammatory medications that affect the whole body.
    • Immunomodulators: These are drugs that help to regulate or normalize the immune system.
    • Biologic therapy: These are advanced treatments that target specific parts of the immune system.
    • The study is open to both male and female patients.
    • The study includes patients who are considered part of a vulnerable population, which means they may need extra protection or care.

Who cannot join the trial?

8 criteria

  • Patients who have a different condition than Moderately to Severely Active Ulcerative Colitis cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication cannot participate.
  • Patients who have other health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently cannot participate.
  • Patients who have allergies to the study medication or its ingredients cannot participate.
  • Patients who are taking certain medications that might interfere with the study cannot participate.
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Investigated drugs

Ozanimod is an oral medication being studied for its effectiveness in treating children with moderately to severely active ulcerative colitis. This condition involves inflammation of the colon, and the medication aims to help reduce this inflammation and improve symptoms. The trial is focused on patients who have not responded well to traditional treatments.

What is already known about the treatment

Ozanimod – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active ulcerative colitis, particularly in pediatric patients who have not responded well to conventional treatments. Ozanimod is classified as a sphingosine 1-phosphate receptor modulator, which works by selectively targeting specific receptors to reduce inflammation in the colon. It is still under investigation, and its use is primarily documented in medical literature related to ongoing clinical trials.

Investigated diseases

Ulcerative Colitis – Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by inflammation and ulceration of the innermost lining of the large intestine. Symptoms often include abdominal pain, diarrhea, and rectal bleeding. The disease typically progresses with periods of flare-ups and remissions. During flare-ups, symptoms can become more severe, while remissions may bring relief. The exact cause is unknown, but it is believed to involve an abnormal immune response.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2023-509248-86-00Protocol codeIM047-001Estimated enrolment128 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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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).