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

Phase 3

Terminated

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

• Registration Number: NCT02514967
• 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 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 available

Study Timeline

• Study First Submitted: 2015-07-31
• Study First Submitted QC: 2015-07-31
• Study First Posted: 2015-08-04
• Study Start: 2016-06
• Primary Completion: 2016-11
• Study Completion: 2017-02-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-19
• Last Update Posted: 2017-05-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

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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

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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-6 composite responder index	52 Weeks

Secondary Outcome Measures

Name	Time	Method
Time to first severe SLE flare	Baseline through 52 weeks
Proportion of subjects with improved patient-reported outcomes	Week 52
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 to ≤ 7.5 mg	Baseline through 52 weeks
Time to treatment failure	Through week 52
Change from baseline in B cell counts, anti-dsDNA, C3, C4	Through week 52
Number of adverse events	Through week 52

Trial Locations

Locations (3)

Investigator Site 004; 🇬🇪 Tbilisi, Georgia

Investigator Site 002; 🇬🇪 Tbilisi, Georgia

Investigator Site 001; 🇬🇪 Tbilisi, Georgia