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

NCT06856135 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-02-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Vedolizumab IV

Participants will continue to receive vedolizumab IV at the same dose administered at the end of Trial Vedolizumab-2005 (NCT03196427), at a frequency of every 8 weeks. • Other Names: * MLN0002 * ENTYVIO * KYNTELES

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06856135 on ClinicalTrials.gov