HUBBLE
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease
IRAS ID
225434
Contact name
Matthias Zilbauer
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2017-002231-41
Duration of Study in the UK
2 years, 3 months, 25 days
Research summary
This is a phase 2, randomised, double-blind, dose-ranging study involving paediatric participants with moderately to severely active Ulcerative colitis (UC) or Crohn’s disease (CD) who have had an inadequate response to, loss of response to, or intolerance of at least 1 of the following medications: corticosteroids, immunomodulators, and/or TNF-α antagonist therapy.
The incidence of paediatric inflammatory bowel disease (IBD) appears to be increasing. Although UC and CD are separate illnesses, they share many common signs and symptoms. Symptoms include diarrhoea, abdominal pain, foecal urgency, and incontinence. Fever, weight loss , malaise, and fatigue are indicators of more extensive disease.
Vedolizumab IV has been granted marketing approval in over 50 countries, including the European Union, for the treatment of adult patients with moderately to severely active UC or CD who have failed conventional treatment. There remains an unmet medical need in paediatric patients who fail to respond/lose response to, all existing therapy, or in whom side effects of these agents are intolerable or life threatening. Vedolizumab IV may provide an alternative therapy for this patient population, but to date no studies have been completed for the use of Vendolizumab IV in paediatric patients.
This study will evaluate the pharmacokinetics, efficacy, immunogenicity, safety, and tolerability of vedolizumab administered by intravenous infusion. Approximately 80 paediatric participants will be enrolled to ensure 40 participants weighing 30kg and more, and 40 participants weighing less than 30kg, as well as a minimum of 36 participants with UC and 36 with CD will be enrolled in the study. The total duration of the study will be approximately 36 weeks from start of the Screening Period to the post-treatment Final Safety Visit.
Eligible participants dependent on their weight, will be randomised to receive vedolizumab IV at either high dose (300mg or 200mg) or low dose (150mg or 100mg)
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0257
Date of REC Opinion
15 Nov 2017
REC opinion
Further Information Favourable Opinion