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Study on the Long-Term Safety and Efficacy of Oral Ozanimod for Patients with Moderate to Severe Crohn's Disease

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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 the effects of a medication called Ozanimod on individuals with Crohn's Disease, which is a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain and diarrhea. The study aims to understand the long-term safety and effectiveness of Ozanimod for people who have moderate to severe forms of this disease. Ozanimod is taken orally in the form of a hard capsule.

Participants in the study will receive Ozanimod and will be monitored over a period to observe how their symptoms change. The study will look at various aspects, such as the reduction in abdominal pain and stool frequency, and improvements in the condition of the digestive tract. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Ozanimod.

The study is designed to gather information over several years, providing insights into how Ozanimod can help manage Crohn's Disease in the long term. Participants will be regularly assessed to track their progress and any changes in their condition. This research is important for developing better treatments for those living with Crohn's Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose, which is to evaluate the long-term safety and effectiveness of ozanimod for treating moderately to severely active Crohn's disease.

    The patient will be required to provide written consent to participate in the study.

  2. Step 2

    Medication administration

    The patient will receive ozanimod in the form of a hard capsule, taken orally.

    The dosage and frequency of administration will be determined by the study protocol and communicated to the patient by the study team.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will undergo regular assessments to monitor the effectiveness and safety of the treatment.

    These assessments may include measuring the Crohn's Disease Activity Index (CDAI) score, which evaluates the severity of symptoms, and the Simple Endoscopic Score for Crohn's Disease (SES-CD), which assesses the condition of the intestinal lining.

  4. Step 4

    Follow-up visits

    The patient will attend scheduled follow-up visits to track progress and any changes in symptoms.

    During these visits, the study team will collect data on the patient's response to the treatment and any side effects experienced.

  5. Step 5

    Completion of the study

    Upon completion of the study, the patient will have a final assessment to evaluate the overall impact of the treatment.

    The study is estimated to conclude by March 24, 2031, at which point the patient will be informed of the study's findings and any further recommendations.

Who can join the trial?

8 criteria

  • Patients must have **moderately to severely active Crohn's Disease**. This means their condition is not mild and requires more intensive treatment.
  • Patients who did not respond or did not achieve remission after 12 weeks in specific previous studies, or those who experienced a relapse or completed certain studies, are eligible.
  • Patients must not have any restrictions according to local laws and must provide written consent before any study procedures begin.
  • Patients must be able to follow the study schedule and requirements.
  • **Female patients of childbearing potential** must agree to use a highly effective method of birth control during the study and until the 90-day follow-up visit. This includes methods like hormonal contraception, intrauterine devices, or complete abstinence.
  • Female patients must not have had a **hysterectomy** (removal of the uterus) or **bilateral oophorectomy** (removal of both ovaries), or must not have been postmenopausal for at least 24 months.
  • Both **male and female patients** are eligible to participate in the study.
  • The study includes patients from certain age groups, specifically those categorized as age range 3 and 4.
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Investigated drugs

Ozanimod is a medication being studied for its potential to treat moderately to severely active Crohn's Disease. It is taken orally and is part of a long-term study to assess its safety and effectiveness in managing the symptoms of this condition.

What is already known about the treatment

Ozanimod – Ozanimod is administered orally and is currently being studied in clinical trials for its long-term safety and efficacy in treating moderately to severely active Crohn's Disease. It is an investigational medication, meaning it is still under research and not yet fully approved for widespread medical use. The main therapeutic indication for Ozanimod is Crohn's Disease, a chronic inflammatory condition of the gastrointestinal tract. At the molecular level, Ozanimod works by modulating the immune system, specifically targeting certain receptors to reduce inflammation. It is classified pharmacologically as a sphingosine-1-phosphate (S1P) receptor modulator.

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. During active phases, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. 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 people experiencing mild symptoms and others having more severe manifestations. Over time, the inflammation can cause damage to the digestive tract, affecting its ability to function properly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511553-22-00Protocol codeRPC01-3204Estimated enrolment978 patientsSponsorCelgene International II S.a.r.l.

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