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

August 11, 2015 updated by: Anthera Pharmaceuticals

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 autoantibody positive, clinically-active Systemic Lupus Erythematosus (SLE) as defined by SELENA SLEDAI score ≥10.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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-8 composite responder index
Time Frame: 52 Weeks
52 Weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline
Time Frame: 52 Weeks
52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-SLE3332

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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