IV Vedolizumab and Crohn’s Disease in Children
The purpose of this clinical trial is to determine the safety and efficacy of vedolizumab intravenous in children aged two to 17, and diagnosed with moderate to severely active Crohn’s disease.
About
Protocol Description
A Randomized, Double-Blind, Phase 3 Study to Evaluate the Efficacy and Safety of Vedolizumab Intravenous as Maintenance Therapy in Pediatric Subjects with Moderately to Severely Active Crohn’s Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy
This is a double-blind, multicenter, prospective, randomized study to evaluate the safety and efficacy of vedolizumab intravenous in pediatric patients aged two to 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 one of three body weight-stratified vedolizumab intravenous doses on day one, week two, and week six of the 14-week induction period. Research participants that 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 one of three body weight-stratified categories. In the maintenance phase, vedolizumab intravenous will be administered every eight weeks, commencing on week 14 and concluding at week 46. The maintenance period will conclude at week 54.
Eligibility Criteria
Inclusion Criteria
- Children aged 2 to 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 (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor alpha (TNF-α) antagonist therapy (eg, infliximab, adalimumab).
Exclusion Criteria
- Research participant 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 >3 small intestine resections.
- Received an investigational biologic within 60 days or five half-lives before screening (whichever period is longer)
- Had previous exposure to approved or investigational anti-integrins
Primary Investigator
Dr. Garin-Laflam is a pediatric gastroenterologist with Carilion Clinic and concurrently holds an academic appointment as Associate Professor of Pediatrics with Virginia Tech Carilion School of Medicine. Dr. Garin-Laflam’s clinical interests revolve around clinical trials, quality improvement, inflammatory bowel disease, and treatment of other gastrointestinal illnesses in children.
Contact Information
Cyrus Legard, MPH
Clinical Research Coordinator
