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

Anthera Pharmaceuticals0 sitesDecember 2015

ConditionsSystemic Lupus Erythematosus

InterventionsPlacebo Blisibimod

DrugsBlisibimod Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Systemic Lupus Erythematosus
Sponsor: Anthera Pharmaceuticals
Primary Endpoint: Proportion of responders to the SRI-8 composite responder index
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2015

End Date

June 2018

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anthera Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
•Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
•Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
•Subjects with stable nephritis may be enrolled
•18 years of age or older

Exclusion Criteria

•Severe active vasculitis, active central nervous system lupus, uncontrolled hypertension or poorly controlled diabetes
•Malignancy within past 5 years
•Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
•Liver disease
•Anemia, neutropenia, or thrombocytopenia
•Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
•History of active tuberculosis or a history of tuberculosis infection
•Pregnant or nursing

Arms & Interventions

Placebo

Intervention: Placebo

Blisibimod

Intervention: Blisibimod

Outcomes

Primary Outcomes

Proportion of responders to the SRI-8 composite responder index

Time Frame: 52 Weeks

Secondary Outcomes

Time to first severe SLE flare(Baseline through 52 weeks)
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity(52 Weeks)
Change in proteinuria from baseline(Week 52)
Proportion of subjects able to reduce oral steroid dose(Baseline through 52 weeks)
Proportion of subjects with improved patient-reported outcomes(Week 52)
Time to treatment failure(Through week 52)
Change from baseline in B cell subsets, anti-dsDNA, C3, C4(Through week 52)
Safety profile (AEs, vital signs, labs, physical exams)(Through week 52)