Efficacy and Safety of Vedolizumab in children with Crohn’s Disease
Research type
Research Study
Full title
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 Ulcerative Colitis Who Achieved Clinical Response Following Open–Label Vedolizumab Intravenous Therapy
IRAS ID
1003594
Contact name
Raghavan Vasudevan
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc.
Eudract number
2020-004301-31
Clinicaltrials.gov Identifier
Research summary
Chron's Disease (CD) is a disease causing diarrhoea (often with blood) and lower abdominal pain. Standard treatments for CD are steroids and biological therapies that help reduce swelling, redness and ulcers seen in CD. Not all patients respond to these treatments, they do not benefit from treatment or experience side effects therefore there is a need for alternative treatments. Vedolizumab is a type of protein that has been artificially made to appear like a human antibody to provide an alternative therapy. Vedolizumab has been approved for use in adult patients however has not yet been approved for use in children. This study, funded by Takeda Pharmaceuticals, is to determine whether Vedolizumab can be used to successfully and safely treat UC in the paediatric population. This study will assess how effective the drug is, check for any side effects and will determine the best dose for children of different weights. Signs of patients developing their own antibodies that might stop vedolizumab working will also be investigated. Patients will receive two different doses of the drug to be compared to find the optimum dose. The participants & families will be in the study for a minimum of 58 weeks. They will be given detailed consent forms explaining the study and if they agree to participate they will sign the consent forms. The study will have a screening period of max. 28 days before study drug is given. If eligible the patient will enter an induction period of 20 weeks to assess their initial response to the treatment. If there is a positive response the patient will enter the Maintenance period of 36 weeks where responses, relapses and side effects that may occur will be assessed. Patients will have to attend hospital visits for assessments such as blood, stool and urine tests, questionnaires and camera examinations of the bowel called colonoscopies. Globally approximately 120 patients will be recruited across 26 countries including the UK.
REC name
Wales REC 5
REC reference
21/WA/0225
Date of REC Opinion
28 Sep 2021
REC opinion
Further Information Unfavourable Opinion