Study of UTTR1147A in Moderate to severe ulcerative colitis patients
Research type
Research Study
Full title
A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLEDUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
IRAS ID
250709
Contact name
Alexandra Kent
Contact email
Sponsor organisation
Genentech, Inc
Eudract number
2017-002350-36
Duration of Study in the UK
2 years, 1 months, 23 days
Research summary
Ulcerative Colitis (UC) is a chronic inflammatory condition of the colon. UC is characterised by ulceration of the lining of the large bowel (colon), bloody diarrhoea, and abdominal pain.
Current treatments for moderate to severe UC rely on suppressing the immune system with corticosteroids and other immuno-suppressants. When these treatments fail, biologic therapies are used to target proteins involved in causing inflammation, such as antitumour necrosis factor (infliximab/adalimumab) and anti-integrins (vedolizumab). Unfortunately, some patients do not respond to these treatments, leaving the final option of surgery, to remove the colon. This outcome is most feared by patients, as they will need a stoma: an opening in the abdominal wall for draining faeces into a bag. The aim for newer therapies is to change the course of the disease with a view to decreasing dependence on corticosteroids and the need for surgery, without significantly compromising patients’ immune system. Suppressing the immune system makes patients more vulnerable to infections, ranging from the common cold to more serious infections such as tuberculosis.UTTR1147A is an investigational product being developed by Genentech Inc. UTTR1147A is a specially modified version of a protein called interleukin-22 (IL-22), which is a substance normally made by the body. IL-22 does several things, one of which is to help repair tissue damage by encouraging the growth of new tissue. This is a Phase II, randomized, parallel-group, double-blind, double-dummy, placebo-controlled, multicentre study to evaluate the efficacy, safety, and pharmacokinetics of UTTR1147A compared with placebo and compared with vedolizumab in the treatment of moderate to severe UC. This study will consist of a screening period (to ensure patients are suitable), treatment period to test the induction of clinical remission and a maintenance period to test the durability of clinical remission, and a safety follow-up period.
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1925
Date of REC Opinion
10 Dec 2018
REC opinion
Favourable Opinion