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Study on Long-term Safety of Vedolizumab and Prednisone in Children with Ulcerative Colitis or Crohn's Disease

Verified siteRegistered drugNo placebo
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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 evaluating the long-term safety of a medication called Vedolizumab in children and teenagers with Ulcerative Colitis or Crohn's Disease. These are chronic conditions that cause inflammation in the digestive tract, leading to symptoms like abdominal pain, diarrhea, and fatigue. The study aims to understand how safe Vedolizumab is when used over an extended period in young patients with these conditions.

Participants in the study will receive Vedolizumab through an intravenous infusion, which means the medication is given directly into a vein. The study will also involve a comparison with a placebo to assess the safety profile of Vedolizumab. Another medication, Prednisone, a type of corticosteroid, may also be used in the study. Prednisone is commonly used to reduce inflammation and suppress the immune system. The study will monitor participants for any adverse events or side effects that may occur during the treatment period.

The study will follow participants over a period of time to observe any long-term effects of Vedolizumab treatment. This includes tracking any major events related to inflammatory bowel disease, such as hospitalizations or surgeries, and assessing changes in health scores for participants aged 9 to 17 years. The goal is to ensure that Vedolizumab is safe for long-term use in managing Ulcerative Colitis and Crohn's Disease in pediatric patients.

The research process

The trial runs in 4 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 must have completed a previous study and achieved a specific clinical response without the use of corticosteroids for at least 12 weeks before the 54th week of that study.

    The patient or their guardian must sign a consent form and agree to comply with the study requirements.

  2. Step 2

    Treatment administration

    The patient will receive vedolizumab through an intravenous infusion. This medication is used to evaluate its long-term safety in treating pediatric patients with ulcerative colitis or Crohn's disease.

    The specific dosage and frequency of administration will be determined by the study protocol and the healthcare provider overseeing the treatment.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient will be monitored for any adverse events or safety concerns. This includes checking for serious infections, growth and development issues, and any need for bowel surgery.

    Regular assessments will be conducted to track changes in the patient's condition and response to the treatment.

  4. Step 4

    Completion of the study

    The study is expected to continue until February 14, 2030. Upon completion, the patient's overall health and response to the treatment will be evaluated.

    The primary focus is on the safety profile of the treatment, with secondary assessments on the time to major disease-related events and changes in health scores for patients aged 9 to 17 years.

Who can join the trial?

9 criteria

  • The patient must have **Active Ulcerative Colitis (UC)** or **Crohn's Disease (CD)**. These are conditions that cause inflammation in the digestive tract.
  • The patient, or their parent or legal guardian, must be able to understand and follow the study requirements, according to the investigator's opinion.
  • The patient, or their parent or legal guardian, must sign a written consent form and any necessary privacy documents before starting any study procedures.
  • The patient must be under 18 years old and have UC or CD. If the patient turns 18 during the study, they may need to switch to a commercial drug if available in their country.
  • The patient must have completed a previous study (Study MLN0002-3024 or Study MLN0002-3025) and shown improvement without using corticosteroids by Week 54. This means a reduction in specific scores that measure disease activity.
  • If the patient is a sexually active male, he must agree to use a barrier method of contraception, like a condom, during the study and for 18 weeks after the last dose. His female partner should also use a highly effective method of contraception.
  • If the patient is a sexually active female of childbearing potential, she must agree to use a highly effective method of contraception during the study and for 18 weeks after the last dose.
  • For the observational part of the study, the patient, or their parent or legal guardian, must sign a written consent form.
  • The patient must have received at least one dose of vedolizumab in a previous study (Study MLN0002-3024 or Study MLN0002-3025) and either left the study early or completed the Week 54 visit but was not eligible for the treatment part of this study.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that could affect their safety during 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 known allergy or reaction to the study medication or similar medications.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse that could interfere with the study.
  • Patients with certain infections that could be worsened by the study medication.
  • Patients with a history of cancer, except for certain types of skin cancer.
  • Patients with a weakened immune system, which means their body has a harder time fighting infections.
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Investigated drugs

Vedolizumab is a medication used in this clinical trial to evaluate its long-term safety in children with ulcerative colitis or Crohn's disease. It is given through an intravenous infusion, which means it is administered directly into a vein. Vedolizumab works by targeting specific proteins in the body to help reduce inflammation in the gut, which can help manage symptoms of these conditions.

What is already known about the treatment

Vedolizumab – This medication is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in a Phase 3b clinical trial to assess its long-term safety in pediatric patients with active Ulcerative Colitis or Crohn's Disease. Vedolizumab is primarily used to treat these inflammatory bowel diseases by targeting specific proteins in the gut to reduce inflammation. It belongs to a class of drugs known as integrin receptor antagonists, which work by blocking the movement of inflammatory cells into the gut tissue.

Investigated diseases

  • Ulcerative Colitis

    Ulcerative colitis is a chronic inflammatory condition affecting the colon and rectum. It is characterized by continuous inflammation of the innermost lining of the large intestine, leading to symptoms such as abdominal pain, diarrhea, and rectal bleeding. The disease often progresses with periods of remission and flare-ups, where symptoms can become more severe. Over time, the inflammation can cause ulcers to form on the colon lining, potentially leading to complications like anemia or dehydration. The exact cause of ulcerative colitis is not fully understood, but it is believed to involve an abnormal immune response.

  • Crohn's Disease

    Crohn's disease is a chronic inflammatory bowel disease that can affect any part of the gastrointestinal tract, from the mouth to the anus. It is characterized by patchy areas of inflammation, which can penetrate deep into the layers of the bowel wall. Symptoms often include abdominal pain, diarrhea, weight loss, and fatigue. The disease can progress with periods of remission and exacerbation, where symptoms worsen. Over time, Crohn's disease can lead to complications such as strictures, fistulas, and malnutrition. The exact cause is unknown, but it is thought to involve a combination of genetic, environmental, and immune factors.

Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2023-509046-36-00Protocol codeMLN0002-3029Estimated enrolment240 patientsSponsorTakeda Development Center Americas Inc.

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