A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of AMG 557 in Subjects With Systemic Lupus Erythematosus

Completed · Phase 1 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

This is a multicenter, randomized, double-blind, placebo-controlled, sequential rising single-dose study in which approximately 56 subjects with SLE will be enrolled in 7 dosing cohorts

Key facts

Study ID

NCT02391259

Run by

Amgen

People needed

57

Starts

2006-11-01

Expected to finish

2011-11-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SLE with positive ANA
• Stable disease with no change in SLE therapy within the previous 30 days
• BMI from 18 to 38 kg/m2

You may not qualify if…

• Have had signs or symptoms of a viral, bacterial or fungal infection within 30 days of study randomization
• Evidence of renal disease or liver disease
• Any history of granulomatous disease including autoimmune granulomatous vasculitis and sarcoidosis
• Prior administration of any other biologic that primarily targets the immune system

Where it is running

• Research Site — Anniston, Alabama, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Los Angeles, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Michigan City, Indiana, United States
• Research Site — North Dartmouth, Massachusetts, United States
• Research Site — Manhasset, New York, United States
• Research Site — New York, New York, United States
• Research Site — Rochester, New York, United States
• Research Site — Duncansville, Pennsylvania, United States
• Research Site — Dallas, Texas, United States
• Research Site — Dallas, Texas, United States
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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