Clinical trial NCT02514967: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lupus
Lupus Erythematosus, Systemic
Autoimmune Diseases
A-623
Blisibimod
Nephritis
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-04
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Proportion of responders to the SRI-6 composite responder index
timeFrame: 52 Weeks
Secondary outcomes:
measure: Time to first severe SLE flare
timeFrame: Baseline through 52 weeks
measure: Change in the number of actively tender or swollen joints and in mucocutaneous disease activity
timeFrame: 52 Weeks
measure: Change in proteinuria from baseline
timeFrame: Week 52
measure: Proportion of subjects able to reduce oral steroid dose to ≤ 7.5 mg
timeFrame: Baseline through 52 weeks
measure: Proportion of subjects with improved patient-reported outcomes
timeFrame: Week 52
measure: Time to treatment failure
timeFrame: Through week 52
measure: Change from baseline in B cell counts, anti-dsDNA, C3, C4
timeFrame: Through week 52
measure: Number of adverse events
timeFrame: Through week 52
Other outcomes:
measure: Occurrence of renal flare in subjects with renal manifestations at baseline
timeFrame: 52 Weeks
Locations:
city: Tbilisi
country: Georgia
facility: Investigator Site 004
city: Tbilisi
country: Georgia
facility: Investigator Site 001
city: Tbilisi
country: Georgia
facility: Investigator Site 002
Study officials:
References:
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.