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CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

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ClinicalTrials.gov Identifier: NCT02514967
Recruitment Status : Terminated (Study halted prematurely and will not resume. Subjects were seen until February 2017)
First Posted : August 4, 2015
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 31, 2015
First Posted Date  ICMJE August 4, 2015
Last Update Posted Date May 23, 2017
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
Proportion of responders to the SRI-6 composite responder index [ Time Frame: 52 Weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2015)
  • Time to first severe SLE flare [ Time Frame: Baseline through 52 weeks ]
  • Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [ Time Frame: 52 Weeks ]
  • Change in proteinuria from baseline [ Time Frame: Week 52 ]
  • Proportion of subjects able to reduce oral steroid dose to ≤ 7.5 mg [ Time Frame: Baseline through 52 weeks ]
  • Proportion of subjects with improved patient-reported outcomes [ Time Frame: Week 52 ]
  • Time to treatment failure [ Time Frame: Through week 52 ]
  • Change from baseline in B cell counts, anti-dsDNA, C3, C4 [ Time Frame: Through week 52 ]
  • Number of adverse events [ Time Frame: Through week 52 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 31, 2015)
Occurrence of renal flare in subjects with renal manifestations at baseline [ Time Frame: 52 Weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
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 With or Without Nephritis
Brief Summary 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).
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
    Administered via subcutaneous injection once per week
  • Drug: Placebo
    Administered via subcutaneous injection once per week
Study Arms  ICMJE
  • Experimental: Blisibimod
    Intervention: Drug: Blisibimod
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 19, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2015)
350
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date November 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
  • 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
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 Georgia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02514967
Other Study ID Numbers  ICMJE AN-SLE3343
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 May 2017

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