NCT01395745

CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (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 and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	blisibimod	blisibimod administered via subcutaneous injection every week for 52 weeks
DRUG	Placebo	Placebo will be administered weekly via subcutaneous injection for 52 weeks

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-07-01
• Completion: 2016-10-01
• First posted: 2011-07-18
• Last updated: 2017-02-03

Locations

90 sites across 16 countries: Belarus, Brazil, Colombia, Georgia, Guatemala, Hong Kong, India, Malaysia, Mexico, Philippines, Russia, Singapore, South Korea, Sri Lanka, Taiwan, Thailand