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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Anthera Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01395745
First received: July 14, 2011
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Anthera Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients achieving an SLE Responder Index at week 52 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first severe SLE flare [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change in proteinuria from baseline [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects with improved patient-reported outcomes [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Time to first renal flare [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in B cell subsets, anti dsDNA, C3, C4 [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Safety Profile (AEs, vital signs, labs, physical exams) [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: blisibimod weekly dose Drug: blisibimod
blisibimod administered via subcutaneous injection every week for 52 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo will be administered weekly via subcutaneous injection for 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395745

Contacts
Contact: Monica Gangal 510-856-5600 ext 5574 mgangal@anthera.com

  Show 73 Study Locations
Sponsors and Collaborators
Anthera Pharmaceuticals
  More Information

No publications provided

Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01395745     History of Changes
Other Study ID Numbers: AN-SLE3331
Study First Received: July 14, 2011
Last Updated: August 12, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 21, 2014