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

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

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).

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Blisibimod; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 3

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0102
    • Investigator Site 004
  • Tbilisi, Georgia, 0179
    • Investigator Site 001
  • Tbilisi, Georgia, 0186
    • Investigator Site 002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered via subcutaneous injection once per week
Experimental: Blisibimod	Drug: Blisibimod; Administered via subcutaneous injection once per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of responders to the SRI-6 composite responder index	52 Weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Occurrence of renal flare in subjects with renal manifestations at baseline	52 Weeks

Collaborators and Investigators

• Sponsor: Anthera Pharmaceuticals

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: July 31, 2015
• First Submitted That Met QC Criteria: July 31, 2015
• First Posted (Estimate): August 4, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Lupus; SLE; Autoimmune Diseases; Nephritis; Lupus Erythematosus, Systemic; A-623; Blisibimod
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Nephritis
• Other Study ID Numbers: AN-SLE3343