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Completed

NCT Number: NCT01395745

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigator Site 603, Homyel, Belarus

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blisibimod

Drug

blisibimod administered via subcutaneous injection every week for 52 weeks

Placebo

Drug

Placebo will be administered weekly via subcutaneous injection for 52 weeks

Primary outcomes

  1. Proportion of patients achieving an SLE Responder Index at week 52

    Time frame: Week 52

Secondary outcomes

  1. Time to first severe SLE flare

    Time frame: Week 52

  2. Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone

    Time frame: Week 52

  3. Change in the number of actively tender or swollen joints and in mucocutaneous disease activity

    Time frame: Week 52

  4. Change in proteinuria from baseline

    Time frame: Week 52

  5. Proportion of subjects with improved patient-reported outcomes

    Time frame: Week 52

  6. Time to treatment failure

    Time frame: Week 52

  7. Time to first renal flare

    Time frame: Week 52

  8. Change from baseline in B cell subsets, anti dsDNA, C3, C4

    Time frame: Week 52

  9. Safety Profile (AEs, vital signs, labs, physical exams)

    Time frame: Week 52

Sponsors and collaborators

Lead sponsor

Anthera Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: CHABLIS-SC1

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2011
Registry last updated
Feb 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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