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Lifeline for kids: expanded access to IBD drug

NCT ID NCT06856135

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program provides children and teenagers with moderate to severe ulcerative colitis or Crohn's disease continued access to vedolizumab, a medication given through a vein, after they finish a related study. It is for those who still benefit from the treatment and have no good alternatives. The goal is to keep their disease under control until the drug is widely available in the US.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Crohn disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease Ulcerative colitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Children's Center for Digestive Healthcare

    AVAILABLE

    Atlanta, Georgia, 30342, United States

  • Seattle Children's Hospital

    AVAILABLE

    Seattle, Washington, 98105, United States

  • University of California San Francisco

    AVAILABLE

    San Francisco, California, 94158, United States

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