Safety Study of AMG 811 in Subjects With Systemic Lupus Erythematosus With and Without Glomerulonephritis

Summary

This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, multiple dose escalation study, enrolling approximately 48 subjects. Part A of the study will enroll subjects with Systemic Lupus Erythematosus (SLE) without Glomerulonephritis (GN) into 3 cohorts. Part B of the study will enroll SLE subjects with GN into 3 cohorts. The purpose of the study is to evaluate the multiple dose of AMG 811 on safety. Tolerability and pharmacokinetics.

Timeline

Start

2009-03

Primary completion

2014-06

Completion

2014-08

Publications

• Boedigheimer MJ, Martin DA, Amoura Z, Sanchez-Guerrero J, Romero-Diaz J, Kivitz A, Aranow C, Chan TM, Chong YB, Chiu K, Wang C, Sohn W, Arnold GE, Damore MA, Welcher AA, Sullivan BA, Kotzin BL, Chung JB. Safety, pharmacokinetics and pharmacodynamics of AMG 811, an anti-interferon-gamma monoclonal antibody, in SLE subjects without or with lupus nephritis. Lupus Sci Med. 2017 Sep 14;4(1):e000226. doi: 10.1136/lupus-2017-000226. eCollection 2017.

Drugs

Indications