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Study on the Effectiveness and Safety of Vedolizumab for Children with Chronic Pouchitis Using a Drug Combination

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 studying the treatment of Chronic Pouchitis in children. Chronic Pouchitis is a condition that affects the lining of a pouch created during surgery for ulcerative colitis, leading to inflammation and discomfort. The treatment being tested in this study is called Vedolizumab, which is administered through an intravenous infusion, meaning it is given directly into a vein. Vedolizumab is designed to help reduce inflammation in the digestive tract.

The purpose of this study is to evaluate how effective and safe Vedolizumab is for children with active chronic pouchitis. Participants in the study will receive Vedolizumab over a period of time, and their health will be monitored to see if the treatment helps them achieve clinical remission, which means a reduction in symptoms and inflammation. The study will also look at how well the body tolerates the medication and any potential side effects.

During the course of the study, participants will receive the medication and attend regular check-ups to assess their progress. The study aims to determine if Vedolizumab can help improve the quality of life for children suffering from chronic pouchitis by reducing symptoms and promoting healing in the affected area. This research is important for finding better treatment options for children with this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility is based on criteria such as age (2 to 17 years), weight (at least 10 kg), and a history of specific medical procedures and conditions.

  2. Step 2

    Baseline evaluation

    A baseline evaluation is performed, which includes a video pouchoscopy with biopsy to assess the condition of the pouch.

    The evaluation helps determine the severity of the condition using a scoring system called mPDAI.

  3. Step 3

    Treatment initiation

    The treatment involves the administration of vedolizumab intravenously. This medication is given as a solution for infusion.

    The goal is to assess the effectiveness of vedolizumab in achieving clinical remission by Week 14.

  4. Step 4

    Treatment continuation

    The treatment continues with regular infusions of vedolizumab. The frequency and dosage are determined by the study protocol.

    Monitoring of health status and response to treatment is ongoing throughout the study period.

  5. Step 5

    Mid-study evaluation

    At Week 14, a mid-study evaluation is conducted to assess clinical remission and response to treatment.

    This involves measuring changes in the mPDAI score and other health indicators.

  6. Step 6

    Continued monitoring

    The study continues with further monitoring and assessments at specified intervals, including Week 34.

    These assessments help evaluate long-term effectiveness and safety of the treatment.

  7. Step 7

    Study completion

    Upon completion of the study, a final evaluation is conducted to assess overall outcomes and any changes in health status.

    Participants are provided with information about their health and any necessary follow-up care.

Who can join the trial?

8 criteria

  • The person in charge of the study believes that the child, parent, or legal guardian can understand and follow the study rules.
  • The child, parent, or legal guardian has signed a written consent form and any necessary privacy forms before starting any study activities.
  • The child is between 2 and 17 years old at the time of the first check-up and first dose.
  • The child weighs at least 10 kilograms at the time of the first check-up and first dose.
  • The child has had a surgery called a proctocolectomy and IPAA at least one year before the first check-up.
  • The child has **active chronic pouchitis**, which is a condition affecting the pouch created during surgery. This is confirmed by a score of 5 or more from symptoms reported over 3 days before a special camera test called an endoscopy. The child must also have had at least one previous episode of pouchitis in the past year, lasting at least 4 weeks and treated with antibiotics or other medicines, or the child must not respond well to antibiotics or cannot take them due to side effects.
  • If a male child is sexually active with a female partner who can have children, he agrees to use a **barrier method of contraception**, like a condom with spermicide, during the study and for 18 weeks after the last dose. The female partner should also use a highly effective method of contraception.
  • If a female child can have children and is sexually active with a male partner, she agrees to use a highly effective method of contraception during the study and for 18 weeks after the last dose.

Who cannot join the trial?

9 criteria

  • Patients who have a different condition than active chronic pouchitis cannot participate. Active chronic pouchitis is a long-term inflammation of the pouch created during surgery for ulcerative colitis.
  • Patients who are not within the specified age range for the study cannot participate. The study is for a specific age group.
  • Patients who are not able to follow the study procedures or attend the required visits cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are taking medications that might interfere with the study treatment cannot participate.
  • Patients who have had recent surgery or medical procedures that might affect the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of certain allergies or reactions to the study medication cannot participate.
  • Patients who are part of another clinical trial cannot participate.
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Investigated drugs

Vedolizumab is a medication used in this clinical trial to treat pediatric patients with active chronic pouchitis. It is administered intravenously and works by targeting specific proteins in the body to reduce inflammation in the gut. The trial aims to evaluate how effective, safe, and tolerable this medication is for children, as well as to study how the body processes the drug and whether it triggers any immune response.

What is already known about the treatment

Vedolizumab – This medication is administered intravenously and is currently being studied in a Phase 3 clinical trial for its effectiveness in treating pediatric patients with active chronic pouchitis. Vedolizumab is already recognized in medical literature for its use in other inflammatory bowel diseases. It works by blocking a specific protein that causes inflammation in the gut, helping to reduce symptoms. Vedolizumab is classified as a monoclonal antibody, which targets the immune system to prevent inflammation.

Investigated diseases

Active Chronic Pouchitis – This is a condition that occurs in individuals who have undergone surgery to create an ileal pouch, often due to ulcerative colitis. The pouch becomes inflamed, leading to symptoms such as increased stool frequency, urgency, abdominal pain, and sometimes bleeding. The inflammation is chronic, meaning it persists over a long period and can fluctuate in severity. The disease progresses with periods of exacerbation and remission, where symptoms may worsen or improve. It is considered a rare disease and can significantly impact the quality of life. The condition requires ongoing monitoring to manage symptoms and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504773-20-00Protocol codeVedolizumab-3041Estimated enrolment28 patientsSponsorTakeda Development Center Americas Inc.

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