Vedolizumab IV in the Treatment of PSC (VIADUCT)
Research type
Research Study
Full title
A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease Efficacy and Safety of Vedolizumab IV in the Treatment of PSC in Subjects With Underlying IBD
IRAS ID
197705
Contact name
Douglas Thorburn
Contact email
Sponsor organisation
Takeda Development Centre Europe, Ltd.
Eudract number
2014-003942-28
Duration of Study in the UK
3 years, 11 months, 4 days
Research summary
Primary Sclerosing Cholangitis (PSC) is an uncommon chronic liver disease in which the bile ducts inside and outside the liver progressively decrease in size due to inflammation and scarring (fibrosis) leading to biliary cirrhosis (which leads to a build up of bile in the liver, portal hypertension (an increase in the blood pressure in the portal vein, which carries the blood from the bowel and spleen to the liver) and finally liver failure.
PSC is a disease of relatively young people with 40 being the average age of diagnosis. To date, no therapy has been shown to prevent disease progression of PSC.
There is also evidence to show that patients with PSC suffer from Inflammatory Bowel Disease (IBD) caused by Lymphocytes (a type of white blood cell) migrating to liver and contributing to its inflammation.
This is a phase 3 randomised, global, double-blind, parallel-group study to assess the safety and efficacy of Vedolizumab Intra Venous (IV, an injection into a vein) in non–end-stage PSC patients with underlying Inflammatory Bowel Disease. The study includes a 4-week Screening Period, a 106-week Treatment Period, and an 18-week Follow-up Period starting at Week 102 or the last dose of study drug for early withdrawal subjects.
Vedolizumab IV represents a potential therapeutic agent for PSC as it may be able to block the on-going inflammatory process by binding to a protein called α4β7 integrin which is expressed on the surface of circulating lymphocytes. The objective of this study is to evaluate the efficacy and safety of Vedolizumab in the treatment of non–end-stage PSC patients with underlying IBD.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/0288
Date of REC Opinion
26 May 2016
REC opinion
Further Information Favourable Opinion