A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Overview

About this study

The purpose of this study is to evaluate the effectiveness, safety, pharmacokinetics (PK), and immune response of high and low doses in 3 different weight groups of vedolizumab intravenous (IV) for maintenance of remission in children aged 2 to 17 years, inclusive, who weigh ≥ 10 kg with moderately to severely active Crohn’s disease (CD).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subjects male or female aged 2 to 17 years, inclusive, who weigh ≥ 10 kg at the time of screening and enrollment into the study.
  • Subjects with moderately to severely active CD diagnosed at least 1 month before screening, defined by a PCDAI > 30 and an SES-CD > 6 (or an SES-CD ≥ 4 if disease is confined to terminal ileum).
  • Subjects who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents:
    • corticosteroids, immunomodulators (eg, AZA, 6-mercaptopurine, methotrexate), and/or TNF-α antagonist therapy (e.g., infliximab, adalimumab). This includes subjects who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition.
  • Subjects with extensive colitis or pancolitis of > 8 years’ duration or left-sided colitis of > 12 years’ duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.
  • Subjects with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

Exclusion Criteria:

  • Subjects who have had previous exposure to approved or investigational anti-integrins, including but not limited to natalizumab, efalizumab, etrolizumab, or AMG 181, or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists or rituximab.
  • Subjects who have had prior exposure to vedolizumab.
  • Subjects with hypersensitivity or allergies to any of the vedolizumab excipients.
  • Subjects who have received either:
    • an investigational biologic within 60 days or 5 half-lives before screening (whichever is longer); or
    • an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
  • Subjects with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease.
  • Subjects who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study.
  • Subjects who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or > 3 small intestine resections.
  • Subjects with a current diagnosis of indeterminate colitis.
  • Subjects with clinical features suggesting monogenic very early-onset inflammatory bowel disease.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Michael Stephens, M.D.

Open for enrollment

Contact information:

Claire Ihrke CCRP

(507) 422-5291

Borsch.Claire@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20535315

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