Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT02074020

CHABLIS-SC2: 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
Withdrawn
Phase
Phase 3
Study type
Interventional
Enrollment
0 (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 autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.

Conditions

Interventions

TypeNameDescription
DRUGBlisibimodAdministered via subcutaneous injection once per week
DRUGPlaceboAdministered via subcutaneous injection once per week

Timeline

Start date
2015-12-01
Primary completion
2018-06-01
First posted
2014-02-28
Last updated
2015-08-13

Source: ClinicalTrials.gov record NCT02074020. Inclusion in this directory is not an endorsement.