Clinical Trial: Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-blind, Placebo-controlled, Single Dose, Two-period, Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of AMG 811 in S

Brief 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).

Detailed Summary:
Sponsor: Amgen

Current Primary Outcome: Safety evaluation: Subject incidence of treatment-emergent adverse events, clinically significant changes in vital signs, physical examination endpoints, clinical laboratory safety tests, ECGs and the development of anti-AMG811 antibodies [ Time Frame: 197 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: PK parameters, Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) score and IFN-gamma related gene expression in skin biopsy samples [ Time Frame: 197 days ]

Original Secondary Outcome: Same as current

Information By: Amgen

Dates:
Date Received: July 15, 2010
Date Started: August 2010
Date Completion:
Last Updated: September 12, 2014
Last Verified: September 2014