A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

Phase 3

Suspended

Conditions: Systemic Lupus Erythematosus

Registration Number: SLCTR/2015/002

Lead Sponsor: Anthera Pharmaceuticals, Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology (in addition to criteria 2 and 3 below)

2. Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)

3. Active SLE disease as defined by SELENA-SLEDAI score >10 despite on-going stable corticosteroid therapy

4. 18 years of age or older

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving an SLE Responder Index [a composite score derived from the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group (BILAG) A and B scores and physicians global assessment]<br><br>The primary endpoint variable is modified from SRI-8 to SRI-6<br> [53 weeks]<br>

Secondary Outcome Measures

Name	Time	Method
Time to first severe SLE flare [53 weeks]<br>Proportion of subjects able to reduce oral steroid dose to >7.5 mg/day prednisone [53 weeks]<br>Change in the number of actively tender or swollen joints and in mucocutaneous disease [53 weeks ]<br>Change in proteinuria from baseline [53 weeks ]<br>Proportion of subjects with improved patient-reported outcomes [53 weeks]<br>Time to treatment [53 weeks ]<br>Time to first renal flare [53 weeks ]<br>Change from baseline in B cell subsets, anti dsDNA, C3, C4<br> [53 weeks ]<br>Safety Profile (AEs, vital signs, labs, physical exams) [53 weeks ]<br>