IV Vedolizumab Crohn’s Disease

Summary

This is a double-blind, multicenter, prospective, randomized study to evaluate the safety and efficacy of vedolizumab intravenous in pediatric patients ages 2 – 17, and with moderate to severely active Crohn’s disease. Following informed consent and successful screening for eligibility in this clinical trial, research participants will be assigned to receive 1 of 3 body weight-stratified vedolizumab intravenous doses on day 1, week 2, and week 6 of the 14-week induction period. Research participants who successfully achieve clinical response at week 14 may be randomized into the 40-week maintenance period, which will consist of a high- or low-dose regimen within 1 of 3 body weight-stratified categories. In the maintenance phase, vedolizumab intravenous will be administered every 8 weeks, commencing on week 14 and concluding at week 46. The maintenance period will conclude at week 54.

To be included in IV Vedolizumab Crohn’s Disease, participants must be / have

• Children ages 2 – 17 years
• Must weigh greater than or equal to 10 kilograms at time of screening and enrollment
• Has moderately to severely active CD, unresponsive or intolerant to their current standard of care
• Moderately to severely active CD is diagnosed at least 1 month before screening visit
• Has failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (e.g., azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (e.g., infliximab, adalimumab).

To be included in IV Vedolizumab Crohn’s Disease, participants must not be / have

• Currently requires surgical intervention or will require surgical intervention during progress of clinical trial for Crohn’s disease
• Has a diagnosis of indeterminate colitis
• History of subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, or known fixed stenosis of the intestine, short bowel syndrome, or greater than 3 small intestine resections
• Received an investigational biologic within 60 days or 5 half-lives before screening (whichever period is longer)
• Had previous exposure to approved or investigational anti-integrins