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A Study to Evaluate Safety and Tolerability of Subcutaneous Doses of MEDI-545 in Subjects With Lupus

Lupus Erythematosus, Systemic Clinical Trial

Official title:
A Phase 2A , Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Dose Study to Evaluate the Safety and Tolerability of Multiple Subcutaneous Doses of MEDI-545, A Fully Human Anti-Interferon-Alpha Monoclonal Antibody, In Subjects With Systemic Lupus Erythematosus

Clinical Trial Summary

The primary objective of this study is to evaluate the safety and tolerability of multiple doses of MEDI-545 in subjects with moderately to severely active Lupus.

Clinical Trial Description

The primary objective of this study is to evaluate the safety and tolerability of multiple SC doses of MEDI-545 in subjects ≥ 18 years of age with moderately to severely active SLE despite standard of care. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00657189
Study type Interventional
Source MedImmune LLC
Contact
Status Completed
Phase Phase 2
Start date July 2008
Completion date May 2010
View Details
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