A Study of GSK3196165 in Hand Osteoarthritis
Research type
Research Study
Full title
A multi-centre Phase IIa double-blind, placebo-controlled study to investigate the efficacy and safety of GSK3196165 in subjects with inflammatory hand osteoarthritis.
IRAS ID
191055
Contact name
Christopher Bainbridge
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-003089-96
Duration of Study in the UK
1 years, 6 months, 7 days
Research summary
Hand osteoarthritis (HOA) is the second most common form of osteoarthritis. It is thought that HOA may be caused by the body’s immune system attacking the tissue surrounding the hand joints, causing those joints to become sore and inflamed. The inflammation maybe caused by a substance called GM-CSF released by cells in and around the joints.
This study funded by GlaxoSmithKline will test GSK3196165, a type of medicine called a monoclonal antibody. Normally, the immune system makes antibodies that attack bacteria and viruses, helping to fight infection. Monoclonal antibodies are made in a laboratory and have been purposefully designed to work as medicines by targeting specific cells or substances in the body. GSK3196165 specifically targets and block the action of GM-CSF in the body which may help to reduce the pain due to the inflammation in HOA.
The purpose of this study is to assess how well GSK3196165 works in treating pain and inflammation in HOA and also to test the safety of this treatment.
Participants will have a 50% chance of receiving GSK3196165 or placebo (a medicine that looks like the study medicine but doesn’t contain the actual medicine) given by injection. These groups will be chosen randomly by a computer.
There may be 13 visits during which various tests, questionnaires, lung tests and MRI scans will be carried out.
For the first five weeks, participants will receive an injection under the skin every week, then every other week until the end of the study, for a total of 8 treatments.
The study will last 26 weeks and will include up to 4 weeks screening, 10 weeks of dosing and then a 12 week follow-up period where no study drug will be given.
There will be no further treatment available with GSK3196165 at the end of the study.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
15/YH/0467
Date of REC Opinion
10 Nov 2015
REC opinion
Favourable Opinion