NCT00657189

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lupus Erythematosus, Systemic
• Lupus

Interventions

Type	Name	Description
DRUG	MEDI-545	100 mg once; SC Placebo × 12 doses on other weeks
DRUG	MEDI-545	100 mg every 4 weeks × 4 doses; SC Placebo × 9 doses on other weeks
DRUG	MEDI-545	100 mg every 2 weeks × 7 doses; SC Placebo × 6 doses on other weeks
DRUG	MEDI-545	100 mg every week × 13 doses
DRUG	Placebo	SC Placebo every week × 13 doses

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-04-14
• Last updated: 2016-08-09

Locations

22 sites across 1 country: United States