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

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ClinicalTrials.gov Identifier: NCT01395745
Recruitment Status : Completed
First Posted : July 18, 2011
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 14, 2011
First Posted Date  ICMJE July 18, 2011
Last Update Posted Date February 3, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
Proportion of patients achieving an SLE Responder Index at week 52 [ Time Frame: Week 52 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
Proportion of patients achieving an SLE Responder Index response [ Time Frame: 52 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
  • Time to first severe SLE flare (SFI) [ Time Frame: Baseline through 52 weeks ]
  • Time to treatment failure [ Time Frame: Baseline through 52 weeks ]
  • Proportion of subjects with improved Physicians Global Assessment (PGA) score [ Time Frame: 52 weeks ]
  • Proportion of subjects able to decrease dose of prednisone [ Time Frame: Week 52 ]
  • Proportion of subjects with improved SF-36 scores [ Time Frame: Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: blisibimod
    blisibimod administered via subcutaneous injection every week for 52 weeks
  • Drug: Placebo
    Placebo will be administered weekly via subcutaneous injection for 52 weeks
Study Arms  ICMJE
  • Experimental: blisibimod weekly dose
    Intervention: Drug: blisibimod
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Merrill JT, Shanahan WR, Scheinberg M, Kalunian KC, Wofsy D, Martin RS. Phase III trial results with blisibimod, a selective inhibitor of B-cell activating factor, in subjects with systemic lupus erythematosus (SLE): results from a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2018 Jun;77(6):883-889. doi: 10.1136/annrheumdis-2018-213032. Epub 2018 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2016)
442
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2011)
900
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belarus,   Brazil,   Colombia,   Georgia,   Guatemala,   Hong Kong,   India,   Korea, Republic of,   Malaysia,   Mexico,   Philippines,   Russian Federation,   Singapore,   Sri Lanka,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01395745
Other Study ID Numbers  ICMJE AN-SLE3331
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthera Pharmaceuticals
Study Sponsor  ICMJE Anthera Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Anthera Pharmaceuticals
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP