NCT02514967

CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Anthera Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical efficacy of blisibimod as measured by a composite responder index in subjects who, despite corticosteroid use, continue to have seropositive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA-SLEDAI score ≥10, and positive for anti-double stranded DNA and low complement (C3 or C4).

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Blisibimod	Administered via subcutaneous injection once per week
DRUG	Placebo	Administered via subcutaneous injection once per week

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-11-01
• Completion: 2017-02-28
• First posted: 2015-08-04
• Last updated: 2017-05-23

Locations

3 sites across 1 country: Georgia