Proof of Mechanism Study of GSK2330811 in Diffuse Cutaneous Systemic Sclerosis
Status:
Completed
Trial end date:
2020-07-07
Target enrollment:
Participant gender:
Summary
GSK2330811 is a humanized monoclonal antibody which is in development for systemic sclerosis
(SSc), a rare autoimmune disease with high morbidity and mortality. Currently, there are no
approved disease modifying therapies and it is an area of high unmet medical need. GSK2330811
has been shown to bind and neutralize Oncostatin M (OSM) that has been associated with
fibrosis, vasculopathy and inflammation in a number of diseases. This multi-center,
randomized, double-blind (sponsor open), placebo controlled, proof of mechanism study will be
the first study to evaluate the safety, tolerability, pharmacokinetics (PK) and
pharmacodynamics (PD) of repeat subcutaneous (SC) doses of GSK2330811 in male and female
participants with diffuse cutaneous SSc (dcSSc). Participants with active disease and a
disease duration of <= 60 months will be enrolled. Approximately 24 to 40 participants will
be randomized across two sequential cohorts. Cohort 1 will evaluate a repeat-dose predicted
to provide sub-maximal inhibition of OSM, leading to a dose escalation decision. Cohort 1 is
planned to consist of at least 4 participants, randomized such that 3 participants will
receive GSK2330811 100 milligram (mg) and 1 will receive placebo. Cohort 2 is planned to
consist of at least 20 participants, randomized such that participants will receive
GSK2330811 300 mg and placebo in a 3:1 ratio respectively. The duration of the study is up to
34 weeks including a screening period of up to 6 weeks, treatment period of 12 weeks and
follow-up period of 16 weeks.