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

Phase 3

Withdrawn

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Placebo; Drug: Blisibimod

• Registration Number: NCT02074020
• Lead Sponsor: Anthera Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-02-28
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13
• Study Start: 2015-12
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Blisibimod	Blisibimod	-

Primary Outcome Measures

Name	Time	Method
Proportion of responders to the SRI-8 composite responder index	52 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity	52 Weeks
Change in proteinuria from baseline	Week 52
Proportion of subjects able to reduce oral steroid dose	Baseline through 52 weeks
Proportion of subjects with improved patient-reported outcomes	Week 52
Time to treatment failure	Through week 52
Change from baseline in B cell subsets, anti-dsDNA, C3, C4	Through week 52
Safety profile (AEs, vital signs, labs, physical exams)	Through week 52
Time to first severe SLE flare	Baseline through 52 weeks