CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

Phase 3

Completed

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

• Registration Number: NCT01395745
• Lead Sponsor: Anthera Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-14
• Study First Submitted QC: 2011-07-15
• Study First Posted: 2011-07-18
• Study Start: 2013-02
• Primary Completion: 2016-07
• Status Verified: 2016-08
• Study Completion: 2016-10
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 442

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
• 18 years of age or older

Exclusion Criteria

• Severe active vasculitis, active central nervous system lupus, active lupus nephritis, 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
blisibimod weekly dose	blisibimod	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving an SLE Responder Index at week 52	Week 52

Secondary Outcome Measures

Name	Time	Method
Time to first severe SLE flare	Week 52
Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone	Week 52
Change in the number of actively tender or swollen joints and in mucocutaneous disease activity	Week 52
Change in proteinuria from baseline	Week 52
Safety Profile (AEs, vital signs, labs, physical exams)	Week 52
Time to first renal flare	Week 52
Change from baseline in B cell subsets, anti dsDNA, C3, C4	Week 52
Proportion of subjects with improved patient-reported outcomes	Week 52
Time to treatment failure	Week 52

Trial Locations

Locations (90)

Investigator Site 603; 🇧🇾 Gomel, Belarus

Investigator Site 604; 🇧🇾 Minsk, Belarus

Investigator Site 601; 🇧🇾 Minsk, Belarus

Investigator Site 605; 🇧🇾 Minsk, Belarus

Investigator Site 602; 🇧🇾 Vitebsk, Belarus

Investigator Site 558; 🇧🇷 Curitiba, Brazil

Investigator Site 555; 🇧🇷 Goiania, Brazil

Investigator Site 557; 🇧🇷 Juiz de Fora, Brazil

Investigator Site 551; 🇧🇷 Porto Alegre, Brazil

Investigator Site 559; 🇧🇷 Santo Andre, Brazil

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