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Study on the Long-Term Safety and Effectiveness of Ozanimod for Adults with Moderate to Severe Ulcerative Colitis

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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 long-term safety and effectiveness of a medication called Ozanimod for treating a condition known as Ulcerative Colitis. Ulcerative Colitis is a chronic disease that causes inflammation and sores in the lining of the large intestine, which can lead to symptoms like abdominal pain and diarrhea. The medication being tested, Ozanimod, is taken orally in the form of a hard capsule and is known by the code name RPC1063.

The purpose of this study is to determine whether long-term use of Ozanimod is safe and effective for people with moderate to severe Ulcerative Colitis. Participants in the study will take Ozanimod over an extended period, and researchers will monitor their health to see how well the medication works and if there are any side effects. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Ozanimod.

Throughout the study, participants will have regular check-ups to assess their condition and any changes in their symptoms. The study aims to gather information on how many patients experience improvements, such as clinical remission, which means the symptoms of Ulcerative Colitis are reduced or disappear. The study will also look at other factors like endoscopic improvement, which involves examining the inside of the colon to see if there is less inflammation, and whether patients can achieve remission without the use of corticosteroids, a type of medication often used to reduce inflammation.

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

    Participation begins after completing a previous trial of RPC1063 and meeting specific criteria.

    Written informed consent is required before any trial-related procedures.

  2. Step 2

    Medication administration

    The medication used in this trial is Ozanimod, administered in the form of a hard capsule.

    The route of administration is oral, meaning the capsule is taken by mouth.

  3. Step 3

    Treatment duration

    The trial is an open-label extension, meaning it continues from a previous study without a set end date for individual participation.

    The estimated end date for the trial is December 31, 2024.

  4. Step 4

    Safety and efficacy evaluation

    The main objective is to evaluate the long-term safety and effectiveness of RPC1063 for treating moderate to severe ulcerative colitis.

    Safety assessments include monitoring adverse events and changes in clinical laboratory measures, vital signs, and other health indicators.

  5. Step 5

    Follow-up

    A 90-day safety follow-up visit is required after completing the trial to ensure ongoing safety and monitor any delayed effects of the treatment.

Who can join the trial?

3 criteria

  • Must have previously participated in a trial of RPC1063 and meet the criteria for participation in the open-label extension as outlined in the prior trial.
  • Female patients of childbearing potential: Must agree to use a highly effective method of birth control throughout the trial until the 90-day safety follow-up visit is completed. This means using methods that have a very low chance of pregnancy when used correctly. Acceptable methods include hormonal birth control (like pills, patches, or injections), an intrauterine device (IUD), an intrauterine hormone-releasing system (IUS), having had a surgical procedure to prevent pregnancy (like tubal occlusion), having a partner who has had a vasectomy, or complete sexual abstinence. A female is considered of childbearing potential if she has started menstruating and has not had surgery to remove her uterus or both ovaries, or has not been without a period for at least 24 months in a row.
  • Must provide written informed consent, which means agreeing in writing to participate in the study after understanding what it involves. Must also be able to follow the schedule of study assessments.

Who cannot join the trial?

4 criteria

  • Patients who do not have ulcerative colitis, which is a condition that causes inflammation and sores in the colon.
  • Patients who are not in the age range specified for the study.
  • Patients who are not considered to have moderate to severe symptoms of ulcerative colitis.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

RPC1063 is an oral medication being studied for its potential to treat moderate to severe ulcerative colitis. This trial aims to assess how safe and effective RPC1063 is when used over a long period. The medication is intended to help manage the symptoms of ulcerative colitis, which is a chronic condition affecting the colon.

What is already known about the treatment

RPC1063 – This medication is administered orally and is currently being studied in a Phase 3 clinical trial for its use in treating moderate to severe ulcerative colitis. It is an investigational drug, meaning it is still under research and not yet widely available in medical practice. The main therapeutic indication for RPC1063 is ulcerative colitis, a chronic inflammatory condition of the colon. At the molecular level, RPC1063 works by modulating the immune system to reduce inflammation in the colon. It is classified pharmacologically as a sphingosine 1-phosphate receptor modulator.

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. Over time, the inflammation can lead to complications such as strictures or increased risk of colon cancer. The exact cause is unknown, but it is believed to involve an abnormal immune response in genetically susceptible individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514815-92-00Protocol codeRPC01-3102Estimated enrolment722 patientsSponsorCelgene International II S.a.r.l.

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