Safety and Efficacy of AMG 592 in Subjects With Active Systemic Lupus Erythematosus
first filed March 2018, updated October 2018
CATEGORIES: General SLE
The phase 1b part of the study is a double-blind, placebo-controlled, multicenter, multiple ascending dose (MAD) study to evaluate the safety, tolerability, PK, and PD of AMG 592 in subjects with SLE. Subjects will be treated for a total of 12 weeks after which they will be followed for an additional 6 weeks for safety and additional PK/PD data collection. Three dosing cohorts are planned for the phase 1b part of the study.
The phase 2a part of the study is a 52-week multicenter, double-blind, placebo-controlled study in subjects with moderate to severe SLE or cutaneous lupus with inadequate response to standard of care therapy. The phase 2a part of the study will commence after a RP2D is identified. Subjects will be randomly assigned in a 2:1 ratio to either AMG 592 or placebo.
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ClinicalTrials.gov identifier: NCT03451422