Phase II Study of a New RIP1 Kinase Inhibitor in Moderate to Severe RA
Research type
Research Study
Full title
Protocol 203168: A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with moderate to severe rheumatoid arthritis.
IRAS ID
206243
Contact name
Peter Taylor
Contact email
Sponsor organisation
GSK UK Plc
Eudract number
2016-000912-13
Duration of Study in the UK
1 years, 6 months, days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine, GSK2982772, a drug that interferes with biochemical pathways in the body that are involved in inflammation. This is the first study with GSK2982772 in moderate to severe rheumatoid arthritis, a disease in which inflammation affects the joints. In the EU, about 30 subjects (8 in the UK) with will be randomly allocated in a 2:1 ratio to receive GSK2982772 (60 mg) as tablets twice daily OR placebo (dummy drug) tablets twice daily. Subjects will be in the study for about 20 weeks: in screening for up to 30 days to ensure the subject is right for the study; on treatment for 12 weeks with 1 weekly visit for the first 3 weeks and 1 visit every 14 days for the 9 following weeks, and in follow-up for 28 days with 1 visit. The study will provide information on how the body handles the drug, the effects of the drug on the body, and provide preliminary efficacy data by 1) assessing joint pain, adverse events, clinical laboratory values via blood samples and vital signs, 2)conducting physical examinations (on 9 visits), 12-lead electrocardiograms (on 10 visits) and MRI scans (on Day 1, Week 6 & 12 visits) and 3) reviewing responses of several questionnaires about fatigue, joint pain and mood. The data will be monitored by a Data Review Committee (DRC) on an ongoing basis.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0297
Date of REC Opinion
5 Sep 2016
REC opinion
Further Information Favourable Opinion