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CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

Primary Purpose

Systemic Lupus Erythematosus

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Blisibimod
Placebo
Sponsored by
Anthera Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod, Nephritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • Subjects with stable nephritis may be enrolled
  • 18 years of age or older

Exclusion Criteria:

  • Severe active vasculitis, active central nervous system lupus, 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Blisibimod

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Proportion of responders to the SRI-8 composite responder index

    Secondary Outcome Measures

    Time to first severe SLE flare
    Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
    Change in proteinuria from baseline
    Proportion of subjects able to reduce oral steroid dose
    Proportion of subjects with improved patient-reported outcomes
    Time to treatment failure
    Change from baseline in B cell subsets, anti-dsDNA, C3, C4
    Safety profile (AEs, vital signs, labs, physical exams)

    Full Information

    First Posted
    February 26, 2014
    Last Updated
    August 11, 2015
    Sponsor
    Anthera Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02074020
    Brief Title
    CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
    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 With or Without Nephritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    December 2015 (undefined)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Anthera Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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 autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus
    Keywords
    SLE, Lupus, Lupus Erythematosus, Systemic, Autoimmune Diseases, A-623, Blisibimod, Nephritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Blisibimod
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Blisibimod
    Intervention Description
    Administered via subcutaneous injection once per week
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Administered via subcutaneous injection once per week
    Primary Outcome Measure Information:
    Title
    Proportion of responders to the SRI-8 composite responder index
    Time Frame
    52 Weeks
    Secondary Outcome Measure Information:
    Title
    Time to first severe SLE flare
    Time Frame
    Baseline through 52 weeks
    Title
    Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
    Time Frame
    52 Weeks
    Title
    Change in proteinuria from baseline
    Time Frame
    Week 52
    Title
    Proportion of subjects able to reduce oral steroid dose
    Time Frame
    Baseline through 52 weeks
    Title
    Proportion of subjects with improved patient-reported outcomes
    Time Frame
    Week 52
    Title
    Time to treatment failure
    Time Frame
    Through week 52
    Title
    Change from baseline in B cell subsets, anti-dsDNA, C3, C4
    Time Frame
    Through week 52
    Title
    Safety profile (AEs, vital signs, labs, physical exams)
    Time Frame
    Through week 52
    Other Pre-specified Outcome Measures:
    Title
    Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline
    Time Frame
    52 Weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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 Subjects with stable nephritis may be enrolled 18 years of age or older Exclusion Criteria: Severe active vasculitis, active central nervous system lupus, 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    33687069
    Citation
    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(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
    Results Reference
    derived

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    CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis

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