CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

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Anthera Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Systemic Lupus Erythematosus

Treatments

Drug: blisibimod
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01395745
AN-SLE3331

Details and patient eligibility

About

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.

Enrollment

442 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
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

442 participants in 2 patient groups, including a placebo group

blisibimod weekly dose
Experimental group
Treatment:
Drug: blisibimod
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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