Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, two-period, crossover study in which approximately 20 subjects with Discoid Lupus Erythematosus will be enrolled to receive AMG 811 and placebo in one of two sequences (ie, AMG 811 followed by placebo or placebo followed by AMG 811).

Timeline

Start

2010-08

Primary completion

2012-09

Completion

2013-03

Outcome

Outcome not reported

Stopped (Enrollment): “The 16 subjects enrolled in the study should enable Amgen to adequately assess safety and tolerabili”

Publications

• Werth VP, Fiorentino D, Sullivan BA, Boedigheimer MJ, Chiu K, Wang C, Arnold GE, Damore MA, Bigler J, Welcher AA, Russell CB, Martin DA, Chung JB. Brief Report: Pharmacodynamics, Safety, and Clinical Efficacy of AMG 811, a Human Anti-Interferon-gamma Antibody, in Patients With Discoid Lupus Erythematosus. Arthritis Rheumatol. 2017 May;69(5):1028-1034. doi: 10.1002/art.40052. Epub 2017 Mar 31.

Drugs

Indications