UNIFI
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis
IRAS ID
163080
Contact name
Jessica Bainbridge
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2014-005606-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 3 months, 0 days
Research summary
Ulcerative colitis is a long-term condition that causes inflammation of the colon (large intestine) and rectum where faeces are made and stored. Ulcerative colitis leads to changes in the colon's lining that can lead to bloody diarrhoea, abdominal pain and urgent need to get to the toilet.
There is currently no medical cure for ulcerative colitis. However, medication is available that can be used to treat the symptoms and prevent them from returning.
Ustekinumab has received marketing approval globally, including countries in North America, Europe, South America, and the Asia-Pacific region, for the treatment of adult patients with chronic moderate to severe plaque psoriasis or active psoriatic arthritis.
The purpose of this study is to determine whether ustekinumab is useful for treating patients with ulcerative colitis.
Study treatment will be divided into two parts, induction and maintenance. Participants will either receive ustekinumab or placebo (a medicine or procedure prescribed for the psychological benefit to the patient rather than for any physiological effect). Participants will be able to switch to study drug if they do not improve.
The study is double-blinded so neither the participant nor the doctor will know which treatment has been assigned throughout the study.
This is a multi-centre study which will take place worldwide in approximately 300 sites. It is anticipated that around 951 participants will be enrolled, with approximately 54 from the UK. This study is sponsored by the pharmaceutical company, Janssen Research & Development, LLC.REC name
London - South East Research Ethics Committee
REC reference
15/LO/1261
Date of REC Opinion
5 Oct 2015
REC opinion
Further Information Favourable Opinion