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

Systemic Lupus Erythematosus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02514967
• Other study ID #: AN-SLE3343
• Status: Terminated
• Phase: Phase 3
• First received: July 31, 2015
• Last updated: May 19, 2017
• Start date: June 2016
• Est. completion date: February 28, 2017

Study information

• Verified date: May 2017
• Source: Anthera Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 28, 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Nephritis
• Systemic Lupus Erythematosus

Intervention

Drug:
• Blisibimod
Administered via subcutaneous injection once per week
• Placebo
Administered via subcutaneous injection once per week

Locations

Country	Name	City	State
Georgia	Investigator Site 001	Tbilisi
Georgia	Investigator Site 002	Tbilisi
Georgia	Investigator Site 004	Tbilisi

Sponsors (1)

Lead Sponsor	Collaborator
Anthera Pharmaceuticals

Country where clinical trial is conducted

Georgia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of renal flare in subjects with renal manifestations at baseline		52 Weeks
Primary	Proportion of responders to the SRI-6 composite responder index		52 Weeks
Secondary	Time to first severe SLE flare		Baseline through 52 weeks
Secondary	Change in the number of actively tender or swollen joints and in mucocutaneous disease activity		52 Weeks
Secondary	Change in proteinuria from baseline		Week 52
Secondary	Proportion of subjects able to reduce oral steroid dose to = 7.5 mg		Baseline through 52 weeks
Secondary	Proportion of subjects with improved patient-reported outcomes		Week 52
Secondary	Time to treatment failure		Through week 52
Secondary	Change from baseline in B cell counts, anti-dsDNA, C3, C4		Through week 52
Secondary	Number of adverse events		Through week 52