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Long-term safety study of subcutaneous vedolizumab in children and adolescents 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 study focuses on two inflammatory bowel conditions: Ulcerative Colitis and Crohn's Disease, which cause inflammation in different parts of the digestive system. The medication being tested is called vedolizumab, which is given as an injection under the skin using either a pre-filled syringe or pen device. The purpose is to evaluate the long-term safety of this treatment in children and teenagers under 18 years of age who have previously responded well to the medication.

The medication will be administered as a solution for injection containing 108 mg of vedolizumab. During the study, participants will receive regular injections of the medication for up to 24 months. The study will monitor how well children and teenagers tolerate long-term treatment with vedolizumab and track any side effects that may occur.

Throughout the study, doctors will watch for any health-related events and track the effectiveness of the treatment. They will pay special attention to how the medication affects the participants' daily lives and overall well-being. The study includes regular check-ups to monitor the participants' health and assess how well the digestive conditions are being controlled by the treatment.

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

    Initial participation

    If you are under 18 years old and have completed Week 34 of the previous study (VedolizumabSC-3003), you may be eligible to participate in this extended study

    You must have achieved clinical response at Week 34 and been free from corticosteroids for at least 4 weeks (Week 30 to Week 34)

  2. Step 2

    Treatment administration

    You will receive Entyvio (vedolizumab) through subcutaneous injection

    The medication will be provided in either a pre-filled syringe or pre-filled pen, containing 108 mg of the medicine

  3. Step 3

    Safety monitoring

    Your health will be monitored for any side effects or reactions to the medication

    Special attention will be paid to infections, liver-related issues, and injection site reactions

    Regular checks will be performed to monitor your response to treatment

  4. Step 4

    Long-term follow-up

    The study will track your progress to evaluate how well the medication works over time

    If you have inflammatory bowel disease (IBD), any related events such as hospitalizations or procedures will be recorded

    If you are between 9 and 17 years old, your quality of life will be assessed using special questionnaires

  5. Step 5

    Study completion

    The study is expected to continue until August 2030

    Upon reaching 18 years of age, you may transition to regular medication if available in your country

Who can join the trial?

10 criteria

  • Patient must be under 18 years old and diagnosed with Ulcerative Colitis (UC) or Crohn's Disease (CD)
  • Patient and/or their legal guardian must be able to understand and follow study requirements
  • Patient and/or their legal guardian must sign informed consent forms before any study procedures begin
  • Patient must have completed Week 34 of the previous study (VedolizumabSC-3003) and achieved:
    • For UC patients: improvement in bowel symptoms, including reduced stool frequency and bleeding
    • For CD patients: improvement in disease activity scores
    • Patient must be free from corticosteroids (a type of anti-inflammatory medication) for at least 4 weeks before Week 34
    • Male patients who are sexually active must agree to use barrier contraception (such as condoms) during the study and for 18 weeks after the last dose
    • Female patients who can become pregnant and are sexually active must use effective contraception during the study and for 18 weeks after the last dose
    • For observation group only:
      • Patient must have received at least one dose of vedolizumab in the previous study
      • Patient either left the previous study early or completed Week 34 but does not qualify for the treatment group

Who cannot join the trial?

16 criteria

  • Previous unsuccessful treatment with vedolizumab (a medication that reduces inflammation in the digestive tract)
  • Active or history of serious infections, including:
  • Tuberculosis (TB)
  • Severe viral infections
  • Parasitic infections
  • History of cancer or pre-cancerous conditions
  • Serious heart, liver, or kidney problems
  • Current pregnancy or breastfeeding
  • Use of other biological medications for treating inflammatory bowel disease within the past 60 days
  • Known allergies to vedolizumab or any of its components
  • Participation in other clinical trials within the past 30 days
  • Any surgical procedures planned during the study period
  • Presence of serious digestive tract infections
  • Inability to comply with study procedures and follow-up visits
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could interfere with study participation
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Investigated drugs

Vedolizumab is a medication given by injection under the skin (subcutaneous) that helps treat ulcerative colitis and Crohn's disease. It works by blocking certain proteins in the body that cause inflammation in the digestive tract. This medication helps reduce symptoms like abdominal pain, diarrhea, and bleeding by decreasing inflammation in the intestines.

What is already known about the treatment

Vedolizumab – A biologic medication administered through subcutaneous injection, specifically developed for treating inflammatory bowel diseases including Ulcerative Colitis and Crohn's Disease. This monoclonal antibody works by selectively blocking the migration of inflammatory cells into the gastrointestinal tissue, thereby reducing inflammation in the digestive tract. As a gut-selective integrin blocker, Vedolizumab belongs to the class of immunosuppressive biological therapies and has shown significant effectiveness in maintaining remission in both adult and pediatric patients with inflammatory bowel diseases, with a favorable long-term safety profile compared to other biologics.

Investigated diseases

  • Ulcerative Colitis

    A chronic inflammatory bowel disease that affects the large intestine (colon) and rectum. The condition causes inflammation and ulcers in the digestive tract's innermost lining. It typically begins gradually and can become worse over time, causing continuous inflammation in some areas of the colon. The disease can cause recurring episodes of abdominal pain, diarrhea, and changes in bowel habits.

  • Crohn's Disease

    A chronic inflammatory condition that can affect any part of the digestive tract from mouth to anus, but most commonly involves the small intestine and beginning of the large intestine. The inflammation extends deep into the layers of affected bowel tissue. The disease commonly occurs in patches, with healthy sections in between affected areas. It can cause abdominal pain, diarrhea, fatigue, and weight loss.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-508804-39-00Protocol codeVedolizumabSC-3004Estimated enrolment66 patientsSponsorTakeda Development Center Americas Inc.

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