NCT00299819

Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)

A Phase I, Randomized, Double-Blind, Placebo Controlled, Dose-Escalation Study to Evaluate Safety and Tolerability of a Single IV Dose of MEDI-545, a Fully Human Monoclonal Antibody Directed Against Interferon Alpha Subtypes, in Patients With Systemic Lupus Erythematosus (SLE)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients with SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of intravenously administered MEDI-545 compared with placebo, over a dose escalation range of 0.3-30 mg/kg, in adult patients who have SLE and who are receiving 20 mg/day or less of prednisone orally or an equivalent dose of another oral corticosteroid. The secondary objective of this study is to describe the pharmacokinetics and potential immunogenicity of MEDI-545.

Conditions

• Lupus

Interventions

Type	Name	Description
BIOLOGICAL	MEDI-545	0.3 mg/kg IV (n=6) at Study Day 0
BIOLOGICAL	MEDI 545	0.3 mg/kg IV (n=6) at Study Day 0
BIOLOGICAL	MEDI-545	0.3 mg/kg IV (n=6) at Study Day 0
BIOLOGICAL	MEDI-545	0.3 mg/kg IV (n=6) at Study Day 0
BIOLOGICAL	MEDI-545	0.3 mg/kg IV (n=6) at Study Day 0

Timeline

• Start date: 2006-03-01
• Completion: 2007-10-01
• First posted: 2006-03-07
• Last updated: 2007-12-18

Locations

21 sites across 2 countries: United States, Canada