POM study of GSK2330811 in diffuse cutaneous systemic sclerosis 201247
Research type
Research Study
Full title
Protocol Title: A multi-centre, randomized, double-blind (sponsor open), placebo controlled,repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis.
IRAS ID
215731
Contact name
Christopher Denton
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Eudract number
2016-003417-95
Duration of Study in the UK
1 years, 11 months, 1 days
Research summary
GSK is starting a study in systemic sclerosis (SSc), a rare disease which can cause severe and progressive symptoms. In the worst cases, these are life-threatening. There are no medicines currently available that change the course of the disease and new, effective treatments are needed.
GSK2330811 is an antibody which blocks the activity of a substance in the body called Oncostatin M (OSM). Blocking OSM is expected to have a beneficial effect on some of the disease processes in SSc (ex: fibrosis and inflammation). If correct, this may reduce symptoms and improve the course of the disease.
This study is designed to look at the safety and tolerability of GSK2330811, how it affects the body and how it is handled by the body (called pharmacokinetics) in participants with diffuse cutaneous SSc (dcSSc).
People who have had SSc for up to 5 years with currently active disease can be included. Some treatments for dcSSc such as mycophenolate and corticosteroids are allowed. The study will enrol participants in two stages. Participants in the first stage will receive a dose of drug expected to block OSM to some extent but not completely. Participants in the second stage will receive a dose of drug expected to block OSM completely. Participants will be treated with GSK2330811 or placebo randomly in a 3:1 ratio within each group. Study assessments will include skin samples, breathing tests and an optional procedure involving making of a skin blister at some centres.
Between 12 and 20 participants in the UK) will be included in the study. Treatment is given via injection, just under the surface of the skin every other week for six doses. The study will be up to 34 weeks long including a run-in (6 weeks), a treatment period (12 weeks) and a follow-up period (16 weeks).REC name
London - Hampstead Research Ethics Committee
REC reference
16/LO/2203
Date of REC Opinion
13 Jan 2017
REC opinion
Further Information Favourable Opinion