This trial is active, not recruiting.

Condition systemic lupus erythematosus
Treatments blisibimod, placebo
Phase phase 3
Sponsor Anthera Pharmaceuticals
Start date February 2013
End date July 2016
Trial size 442 participants
Trial identifier NCT01395745, AN-SLE3331


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
blisibimod administered via subcutaneous injection every week for 52 weeks
(Placebo Comparator)
Placebo will be administered weekly via subcutaneous injection for 52 weeks

Primary Outcomes

Proportion of patients achieving an SLE Responder Index at week 52
time frame: Week 52

Secondary Outcomes

Time to first severe SLE flare
time frame: Week 52
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone
time frame: Week 52
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
time frame: Week 52
Change in proteinuria from baseline
time frame: Week 52
Proportion of subjects with improved patient-reported outcomes
time frame: Week 52
Time to treatment failure
time frame: Week 52
Time to first renal flare
time frame: Week 52
Change from baseline in B cell subsets, anti dsDNA, C3, C4
time frame: Week 52
Safety Profile (AEs, vital signs, labs, physical exams)
time frame: Week 52

Eligibility Criteria

Male or female participants at least 18 years old.

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 - 18 years of age or older Exclusion Criteria: - Severe active vasculitis, active central nervous system lupus, active lupus nephritis, 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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Anthera Pharmaceuticals.