Back to resultsCHABLIS7.5: 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
Terminated
Phase
Phase 3
Locations
Georgia
Study Type
Interventional
Intervention
Blisibimod
Placebo
Sponsored by
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
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
Sites / Locations
- Investigator Site 004
- Investigator Site 001
- Investigator Site 002
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-6 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 to ≤ 7.5 mg
Proportion of subjects with improved patient-reported outcomes
Time to treatment failure
Change from baseline in B cell counts, anti-dsDNA, C3, C4
Number of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02514967
Brief Title
CHABLIS7.5: 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
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Study halted prematurely and will not resume. Subjects were seen until February 2017
Study Start Date
June 2016 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 28, 2017 (Actual)
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 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).
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
3 (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-6 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 to ≤ 7.5 mg
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 counts, anti-dsDNA, C3, C4
Time Frame
Through week 52
Title
Number of adverse events
Time Frame
Through week 52
Other Pre-specified Outcome Measures:
Title
Occurrence of renal flare 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
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
Facility Information:
Facility Name
Investigator Site 004
City
Tbilisi
ZIP/Postal Code
0102
Country
Georgia
Facility Name
Investigator Site 001
City
Tbilisi
ZIP/Postal Code
0179
Country
Georgia
Facility Name
Investigator Site 002
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
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
Learn more about this trial
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
We'll reach out to this number within 24 hrs