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 Pharmaceuticals3 sites in 1 country3 target enrollmentJune 2016

ConditionsSystemic Lupus Erythematosus

InterventionsBlisibimod Placebo

DrugsBlisibimod Placebo

Overview

Phase: Phase 3
Intervention: Blisibimod
Conditions: Systemic Lupus Erythematosus
Sponsor: Anthera Pharmaceuticals
Enrollment: 3
Locations: 3
Primary Endpoint: Proportion of responders to the SRI-6 composite responder index
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites 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 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).

Registry

clinicaltrials.gov

Start Date

June 2016

End Date

February 28, 2017

Last Updated

8 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
•Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
•Positive for anti-double stranded DNA (anti-dsDNA) and low complement
•Subjects with stable nephritis may be enrolled
•18 years of age or older

Exclusion Criteria

•Severe active central nervous system lupus
•Malignancy within past 5 years
•Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
•Comorbidities that would interfere with evaluations of study drug effect
•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

Blisibimod

Intervention: Blisibimod

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of responders to the SRI-6 composite responder index

Time Frame: 52 Weeks

Secondary Outcomes

Time to first severe SLE flare(Baseline through 52 weeks)
Proportion of subjects with improved patient-reported outcomes(Week 52)
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 to ≤ 7.5 mg(Baseline through 52 weeks)
Time to treatment failure(Through week 52)
Change from baseline in B cell counts, anti-dsDNA, C3, C4(Through week 52)
Number of adverse events(Through week 52)