NCT01164917

Safety Study of AMG 811 in Subjects With Discoid Lupus Erythematosus

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 Subjects With Discoid Lupus Erythematosus

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cutaneous Lupus
• Discoid Lupus
• Lupus
• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	AMG811	Twelve subjects will be randomized to receive AMG 811 in Period 1 and will receive AMG 811 Placebo in Period 2. The AMG 811 and AMG 811 Placebo will be administered by injection.
DRUG	AMG811 Placebo	8 subjects will be randomized to receive AMG 811 Placebo in Period 1 and will receive AMG 811 in Period 2. The AMG 811 Placebo and AMG 811 will be administered by injection

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-09-01
• Completion: 2013-03-01
• First posted: 2010-07-19
• Last updated: 2014-09-16

Locations

8 sites across 1 country: United States