NCT01162681

PEARL-SC Trial: A Study of the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-Blind Phase 2b Study to Evaluate the Efficacy, Safety, and Tolerability of A 623 Administration in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 547 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of three different doses of A-623 administered in addition to standard therapy in subjects with active SLE disease

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	A-623	High dose given subcutaneously once a week for up to 52 weeks
DRUG	A-623	Low dose given subcutaneously once a week for up to 52 weeks
DRUG	A-623	High dose given subcutaneously once every 4 weeks for up to 52 weeks
OTHER	Placebo Comparator	Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2010-07-15
• Last updated: 2014-03-04

Locations

74 sites across 11 countries: United States, Argentina, Brazil, Chile, Colombia, Hong Kong, India, Mexico, Peru, Philippines, Taiwan