Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 56 for:    Systemic Lupus Erythematosus with Nephritis 2

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

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.
ClinicalTrials.gov Identifier: NCT02074020
Recruitment Status : Withdrawn
First Posted : February 28, 2014
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Anthera Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Blisibimod Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : December 2015
Estimated Primary Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Blisibimod Drug: Blisibimod
Administered via subcutaneous injection once per week

Placebo Comparator: Placebo Drug: Placebo
Administered via subcutaneous injection once per week




Primary Outcome Measures :
  1. Proportion of responders to the SRI-8 composite responder index [ Time Frame: 52 Weeks ]

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

Other Outcome Measures:
  1. Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline [ Time Frame: 52 Weeks ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • 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

Layout table for additonal information
Responsible Party: Anthera Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02074020     History of Changes
Other Study ID Numbers: AN-SLE3332
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

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

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