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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395745
First Posted: July 18, 2011
Last Update Posted: February 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthera Pharmaceuticals
  Purpose
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.

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: blisibimod Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients achieving an SLE Responder Index at week 52 [ Time Frame: Week 52 ]

Secondary Outcome Measures:
  • Time to first severe SLE flare [ Time Frame: Week 52 ]
  • Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone [ Time Frame: Week 52 ]
  • Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [ Time Frame: Week 52 ]
  • Change in proteinuria from baseline [ Time Frame: Week 52 ]
  • Proportion of subjects with improved patient-reported outcomes [ Time Frame: Week 52 ]
  • Time to treatment failure [ Time Frame: Week 52 ]
  • Time to first renal flare [ Time Frame: Week 52 ]
  • Change from baseline in B cell subsets, anti dsDNA, C3, C4 [ Time Frame: Week 52 ]
  • Safety Profile (AEs, vital signs, labs, physical exams) [ Time Frame: Week 52 ]

Enrollment: 442
Study Start Date: February 2013
Study Completion Date: October 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: blisibimod weekly dose Drug: blisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395745


  Show 90 Study Locations
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01395745     History of Changes
Other Study ID Numbers: AN-SLE3331
First Submitted: July 14, 2011
First Posted: July 18, 2011
Last Update Posted: February 3, 2017
Last Verified: August 2016

Keywords provided by Anthera Pharmaceuticals:
SLE
Lupus
Lupus Erythematosus, Systemic
Autoimmune Diseases
A-623
Blisibimod

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases