Dose response study of GSK2330672 for pruritus in PBC patients 201000
Research type
Research Study
Full title
A randomized, double-blind, multi-dose, placebo-controlled study to evaluate the efficacy, safety and tolerability of GSK2330672 administration for the treatment of pruritus in patients with primary biliary cholangitis.(GLIMMER: GSK2330672 triaL of Ibat inhibition with Multidose Measurement for Evaluation of Response).
IRAS ID
219613
Contact name
David Jones
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Eudract number
2016-002416-41
Duration of Study in the UK
0 years, 11 months, 19 days
Research summary
GSK is conducting a study to compare the efficacy, safety and tolerability of a range of doses of GSK2330672 for the treatment moderate to severe pruritus in adults with primary biliary cholangitis (PBC).
PBC is a rare condition where the bile ducts in the liver become damaged. This causes the build-up of bile acid salts in the body which causes patients to experience persistent itching (pruritus). Current pruritus treatments show variable efficacy, have some unpleasant side-effects and interact with one of the main treatments for PBC ursodeoxycholic acid (UDCA).
GSK2330672 inhibits reabsorption of bile acids in the small bowel and increases their excretion, which may lessen pruritus. It is hoped lower bile acid levels in the liver may improve the course of the underlying disease.
The study aims to find which dose and dose frequency improves pruritus and affects underlying disease. Participants will receive different doses of GSK2330672 or a placebo at different times but will not know when they are on active treatment or a placebo. Most participants will take tablets (GSK2330672 or placebo) for 20 weeks and have a telephone follow-up 4 weeks later; some participants will take tablets for 4 weeks and then stop if their tests show that they are not suitable to continue in the study. Participants may receive some PBC and itch therapies including UDCA; some other treatments for itch are not allowed.
Assessments include: medical history, physical exam, ECG, pregnancy test (if applicable), blood tests. Using an eDiary at each visit participants will complete up to 6 questionnaires on
PBC and its impact, and at home record daily study drug dosing, symptoms of itch, fatigue and sleep quality. Each week, participants will also record details about their tummy and bowel symptoms.
An actigraphy sub-study will assess scratching episodes using a wearable activity monitor.REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/0243
Date of REC Opinion
24 Mar 2017
REC opinion
Further Information Favourable Opinion