Extension study of UTTR1147A in colitis or crohns patients
Research type
Research Study
Full title
A PHASE II OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF UTTR1147A IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS\nOR CROHN’S DISEASE
IRAS ID
242927
Contact name
Alexandra Kent
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2017-004997-32
Duration of Study in the UK
3 years, 3 months, 16 days
Research summary
Ulcerative colitis (UC) and Crohn’s disease (CD), the two most common types of inflammatory bowel disease (IBD), are chronic inflammatory conditions of the colon and gastrointestinal tract.\n\nUC is characterized by inflammation and ulceration of the inner lining of the rectum and colon (the large bowel). In UC, ulcers develop on the surface of the lining and these may bleed and produce mucus. CD is characterised by areas of inflammation often patchy with sections of normal gut in between. A patch of inflammation may be small, or extend quite a distance along part of the gut. As well as affecting the lining of the bowel, CD may also go deeper into the bowel wall. \n\nPatients can present with a variety of symptoms, including nausea, vomiting, abdominal pain, and diarrhoea.\n\nWhile effective therapeutic options, are available to reduce the acute symptomatic flares in disease activity in patients with moderate to severe IBD, no currently available therapy achieves sustained remission in more than 10%-30% of patients with chronic IBD\n\nUTTR1147A 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.\n\nThis open-label extension study (GA40209) will evaluate the long-term safety and tolerability of UTTR1147A in patients with moderate to severe UC or CD. In addition, the study will obtain long-term data on the efficacy, immunogenicity, and exposure of UTTR1147A. This study will enrol up to approximately 320 patients from Phase Ib Study GA29469 and Phase II Study GA39925 (parent studies). [COVID-19 amendment – 09/04/2020] Due to the global COVID-19 pandemic, Genentech has paused screening and enrolment for new patients in countries participating in this trial. The patients who are receiving treatment will continue to do so (they remain in the study) as long as study participation does not lead to added risk to the patient or site personnel. Patients rolled over from GA39925 should continue to get treatment, if eligible and feasible, and judged to be in the best interest of the patient. For patients who develop and resolve COVID-19 infection on study, should be treated as per protocol in GA40209 Table 3 “Guidelines for management of specific adverse events
REC name
London - Westminster Research Ethics Committee
REC reference
18/LO/1927
Date of REC Opinion
4 Jan 2019
REC opinion
Further Information Favourable Opinion