A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-17
SponsorTakeda
About this trial
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).
The participants will be treated with vedolizumab for up to 34 weeks.
During the study, participants will visit their study clinic several times.
Eligibility criteria
Qualifiers
The participant weighs ≥10 kg at the time of screening and enrollment into the study.
Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.)
Participants with CD: a pediatric Crohn's disease activity index (PCDAI) >30 and a simple endoscopic score for Crohn's disease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.
Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (for example, infliximab, adalimumab).
Disqualifiers
Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab.
Participants who have had prior exposure to vedolizumab.
Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.
Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.
Trial design
Treatments tested in this trial
- Vedolizumab IV
- Vedolizumab SC
Treatment groups
70 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov