Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA

February 25, 2026 updated by: Takeda

Expanded Access Program for United States of America: Vedolizumab Intravenous for the Treatment of Pediatric Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease

The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the Vedolizumab-2005 clinical study in the United States (US) with continued access to Vedolizumab Intravenous (IV) which is given as infusion into a vein (intravenously IV) until it becomes commercially available in the US. To be able to participate in this EAP, children and teenagers must still benefit from the treatment with Vedolizumab IV. According to the participant's treating healthcare professional (HCP): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab IV.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • Available
        • University of California San Francisco
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Available
        • Children's Center for Digestive Healthcare
    • Washington
      • Seattle, Washington, United States, 98105
        • Available
        • Seattle Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. The participant has UC or CD and is of age less than (<) 18 years at the time of final treatment completion of Vedolizumab-2005.
  2. The participant is demonstrating continued clinical benefit from vedolizumab IV for the treatment of UC or CD that outweighs possible risks.
  3. The participant, participant's legally authorized representative, or adult caregiver is informed of the nature of this expanded access program and has provided signed and dated written informed consent and/or pediatric assent.
  4. The participant does not have any condition, including laboratory test result, that in the opinion of the investigator may compromise the participant's safety.
  5. The participant does not have a known hypersensitivity to vedolizumab or its components.
  6. According to the participant's treating healthcare professional (HCP): there are no comparable and satisfactory alternative treatment options in the local market, or the participant would be negatively affected without continued access to vedolizumab IV.

  7. Female participants of childbearing potential only:

    • The participant has agreed to be abstinent or agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after completion of the last dose of vedolizumab.
    • The participant is not pregnant or breastfeeding.
    • The participant will not donate ova during the course of the program and for 18 weeks after the last dose of vedolizumab.

  8. Male participants only:

    • The participant has agreed to comply with the applicable contraceptive requirements of this protocol for the duration of the expanded access program and for 18 weeks after the last dose of vedolizumab.
    • The participant has agreed to not donate sperm during the course of the program and for 18 weeks after the last dose of vedolizumab.

Exclusion Criteria:

-No specific exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vedolizumab 4072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe