Safety Study of AMG 557 in Subjects With Subacute Cutaneous Lupus Erythematosus

Summary

This study will be a multicenter, randomized, double-blind, placebo-controlled, multiple dose study in which approximately 24 subjects with SCLE will be enrolled. Cohort 1 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 210 mg or matching placebo. Cohort 2 will consist of 12 subjects (6 AMG 557: 6 placebo) randomized to receive AMG 557 140 mg or matching placebo. Enrollment of Cohort 2 (140 mg) will be initiated after enrollment of Cohort 1 (210 mg) is completed.

Timeline

Start

2011-10

Primary completion

2013-03

Completion

2013-03

Outcome

Outcome not reported

Stopped (Enrollment): “slow enrollment”

Drugs

Indications