HUBBLE ZOOM
Research type
Research Study
Full title
A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease
IRAS ID
225437
Contact name
Matthias Zilbauer
Contact email
Sponsor organisation
Takeda Development Centre Europe Ltd
Eudract number
2017-002182-21
Duration of Study in the UK
6 years, 11 months, 14 days
Research summary
This is a phase 2b, open-label, long-term extension study to determine the long-term safety of Vedolizumab IV in paediatric patients with Ulcerative colitis (UC) or Crohn’s disease (CD) who have received the study medication as part of the study MLN0002-2003.
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, faecal 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 United States and 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, or who 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 long-term safety of vedolizumab administered by intravenous infusion in up to 80 paediatric participants who completed Study MLN0002-2003 and in the opinion of the investigator are expected to benefit from continued vedolizumab treatment. The treatment duration may continue for up to 5 years or until participants withdraw from the study or the sponsor decides to close the study. Participants will be administered the same dose of vedolizumab that they received at Week 14 in study MLN0002-2003 (either low dose 150mg or high dose 300mg), unless participants on the low dose experience disease worsening and can be escalated to the high dose at the discretion of the investigator.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0258
Date of REC Opinion
16 Nov 2017
REC opinion
Further Information Favourable Opinion