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Study on the Effects of Ozanimod for Children with Moderate to Severe Crohn's Disease Not Responding to Usual Treatments

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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 testing a medication called Ozanimod, which is taken orally in the form of hard capsules. The purpose of the study is to evaluate how effective and safe Ozanimod is for children and teenagers who have moderate to severe Crohn's Disease and have not responded well to standard treatments.

Participants in the study will be randomly assigned to receive either Ozanimod or a placebo. The study will last for a period of time, during which participants will take the medication daily. Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The goal is to see if Ozanimod can help achieve clinical remission, which means reducing the symptoms of the disease, and endoscopic remission, which means healing the lining of the intestine, by the end of the study period.

This study is important because it aims to find a new treatment option for young people with Crohn's Disease who have not had success with other therapies. By participating, researchers hope to gather valuable information that could lead to better management of the disease in the future. The study will also look at how the body processes Ozanimod and how it affects the immune system, which plays a role in Crohn's Disease.

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 treatment phase

    Begin taking Zeposia capsules orally. The initial dosage is 0.23 mg per day.

    Continue this dosage for the first 7 days to allow the body to adjust to the medication.

  2. Step 2

    Dose escalation phase

    Increase the dosage to 0.46 mg per day after the initial 7 days.

    Maintain this dosage for the next 7 days.

  3. Step 3

    Maintenance dose phase

    After completing the dose escalation phase, increase the dosage to 0.92 mg per day.

    Continue taking this dosage daily for the remainder of the study period.

  4. Step 4

    Evaluation at week 12

    Undergo an evaluation to assess the effectiveness of the treatment.

    The goal is to achieve a Pediatric Crohn's Disease Activity Index (PCDAI) score of less than 10.

  5. Step 5

    Ongoing treatment and monitoring

    Continue taking the 0.92 mg dosage daily.

    Attend regular follow-up visits for monitoring and assessment.

  6. Step 6

    Final evaluation at week 64

    Undergo a final evaluation to determine the treatment's success.

    The objectives are to achieve clinical remission and endoscopic remission, as measured by the PCDAI and SES-CD scores.

Who can join the trial?

10 criteria

  • The patient must have **moderately to severely active Crohn's Disease**. This means the disease is more than mild but not the most severe form.
  • The patient or their guardian must sign a **Written Informed Consent**. This is a document that explains the study and confirms that they agree to participate.
  • The patient must be willing and able to follow the study schedule and requirements, including swallowing a capsule until a sprinkle form is available.
  • The patient must have been diagnosed with Crohn's Disease at least 3 months before the screening visit. This diagnosis should be confirmed by medical tests and a report from a tissue sample analysis.
  • The patient must have a **PCDAI score** of 30 or higher. This is a score that measures the activity of Crohn's Disease in children.
  • The patient must have a **SES-CD score** of 6 or higher, or 4 or higher if the disease is only in the ileum. This score measures the severity of Crohn's Disease seen during an endoscopy.
  • The patient must have had an inadequate response, intolerance, or loss of response to at least one treatment for Crohn's Disease, such as corticosteroids, immunomodulators, biologic therapy, or other systemic therapies.
  • If the patient is taking certain background therapies for Crohn's Disease, the dose must be stable for a specific period before and during the study. These therapies include oral aminosalicylates, prednisone, oral budesonide, or oral beclomethasone.
  • The patient must have documentation of vaccinations according to the standard schedule, including complete varicella (chickenpox) vaccination at least 30 days before starting the study, or proof of immunity to the varicella zoster virus.
  • The patient must be within the age range specified for the study, which includes children.

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years.
  • Patients who have a history of heart problems or uncontrolled high blood pressure.
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Investigated drugs

Ozanimod (RPC1063) is an oral medication being studied for its effectiveness in treating children with moderately to severely active Crohn's Disease who have not responded well to conventional treatments. The trial aims to determine if taking Ozanimod once daily can help achieve clinical remission and endoscopic remission over a period of 64 weeks.

What is already known about the treatment

Ozanimod – Ozanimod is administered orally and is currently being studied in clinical trials for its effectiveness in treating moderately to severely active Crohn's Disease, particularly in pediatric patients who have not responded well to conventional treatments. It is classified as a sphingosine-1-phosphate (S1P) receptor modulator. The medication works by selectively targeting and modulating specific S1P receptors, which play a role in immune cell movement and inflammation. This action helps reduce inflammation in the gastrointestinal tract, which is beneficial for managing Crohn's Disease.

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 symptoms and remission. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The disease can vary in severity, with some individuals experiencing mild symptoms and others having more severe manifestations. The exact cause is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IVTrial ID2023-508777-91-00Protocol codeIM047-023Estimated enrolment120 patientsSponsorCelgene International II S.a.r.l.

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).