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

This study has been terminated.
(Study halted prematurely and will not resume. Subjects were seen until February 2017)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02514967
First Posted: August 4, 2015
Last Update Posted: May 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthera Pharmaceuticals
  Purpose
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).

Condition Intervention Phase
Systemic Lupus Erythematosus Drug: Blisibimod Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of responders to the SRI-6 composite responder index [ Time Frame: 52 Weeks ]

Secondary Outcome Measures:
  • Time to first severe SLE flare [ Time Frame: Baseline through 52 weeks ]
  • Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [ Time Frame: 52 Weeks ]
  • Change in proteinuria from baseline [ Time Frame: Week 52 ]
  • Proportion of subjects able to reduce oral steroid dose to ≤ 7.5 mg [ Time Frame: Baseline through 52 weeks ]
  • Proportion of subjects with improved patient-reported outcomes [ Time Frame: Week 52 ]
  • Time to treatment failure [ Time Frame: Through week 52 ]
  • Change from baseline in B cell counts, anti-dsDNA, C3, C4 [ Time Frame: Through week 52 ]
  • Number of adverse events [ Time Frame: Through week 52 ]

Other Outcome Measures:
  • Occurrence of renal flare in subjects with renal manifestations at baseline [ Time Frame: 52 Weeks ]

Enrollment: 3
Actual Study Start Date: June 2016
Study Completion Date: February 28, 2017
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blisibimod Drug: Blisibimod
Administered via subcutaneous injection once per week
Placebo Comparator: Placebo Drug: Placebo
Administered via subcutaneous injection once per week

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02514967


Locations
Georgia
Investigator Site 004
Tbilisi, Georgia, 0102
Investigator Site 001
Tbilisi, Georgia, 0179
Investigator Site 002
Tbilisi, Georgia, 0186
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02514967     History of Changes
Other Study ID Numbers: AN-SLE3343
First Submitted: July 31, 2015
First Posted: August 4, 2015
Last Update Posted: May 23, 2017
Last Verified: May 2017

Keywords provided by Anthera Pharmaceuticals:
SLE
Lupus
Lupus Erythematosus, Systemic
Autoimmune Diseases
A-623
Blisibimod
Nephritis

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Nephritis
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases