A study of a new medicine for the treatment of ulcerative colitis
Research type
Research Study
Full title
A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis.
IRAS ID
210358
Contact name
Patrick Allen
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2016-001833-29
Duration of Study in the UK
2 years, 2 months, 3 days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine GSK2982772, a drug that interferes with systems in your body that are involved in your body’s answer to infections. This is the first study with GSK2982772 in ulcerative colitis, a disease in which inflammation affects the large bowel/intestine (colon). About 48 subjects will be randomly selected in a 2:1 ratio to receive GSK2982772 (60 mg) as tablets twice daily OR placebo (dummy drug) tablets twice daily. The study will be divided into two parts, Part A (6 weeks) and Part B (6 weeks).
During Part A, some subjects will receive GSK2982772 tablets, and some will receive a placebo, so we can look for differences between the two groups. After completion of Part A, all subjects will then receive GSK2982772 tablets during Part B.
Subjects will be in the study for about 20 weeks, on treatment for 12 weeks, in screening for up to 30 days and the follow-up period for 28 days. During that time, you will come to the clinic on 10 occasions and will have 6 phone calls from the study staff.
The study will provide information on how the body handles the drug, the effects of the drug on the body, and how well the drug is working by 1) assessing changes in your disease, adverse events, clinical laboratory values via blood and stool samples and vital signs, 2) conducting physical examinations (on 9 visits), 12-lead electrocardiograms (on 9 visits) and sigmoidoscopy, a test using a tube with a camera to look at the inside of your large bowel (at screening, Week 6 & 12 visits) and 3) reviewing responses of several questionnaires about your disease and your mood. The data will be monitored by a Data Review Committee (DRC) on an ongoing basis.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0365
Date of REC Opinion
14 Sep 2016
REC opinion
Further Information Favourable Opinion