CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

Anthera Pharmaceuticals

Status and phase

Withdrawn

Phase 3

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Blisibimod

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02074020

AN-SLE3332

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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