CHABLIS7.5: 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

Terminated

Phase 3

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: Placebo

Drug: Blisibimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT02514967

AN-SLE3343

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 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).

Enrollment

3 patients

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
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