Systemic Lupus Erythematosus Clinical Trial
Official title:
An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus
This is an adaptive, dose ranging, Phase II study to investigate the relationship between
repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients
with active systemic lupus erythematosus (SLE). This study will also investigate the safety
and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses
will be conducted. These are to monitor the pharmacodynamic effect and safety following 2
weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184
following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry
criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive
GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400
mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will
be administered orally up to 12 weeks.
Subjects who complete the study will participate in the study for approximately 21 weeks.
n/a
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