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History of Changes for Study: NCT02514967
CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
Latest version (submitted May 19, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 31, 2015 None (earliest Version on record)
2 March 22, 2016 Study Status
3 June 9, 2016 Recruitment Status, Study Status and Contacts/Locations
4 June 21, 2016 Contacts/Locations and Study Status
5 July 20, 2016 Study Status and Contacts/Locations
6 September 9, 2016 Study Status
7 May 19, 2017 Recruitment Status, Study Status, Contacts/Locations, Study Design
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Study NCT02514967
Submitted Date:  July 31, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: AN-SLE3343
Brief Title: CHABLIS7.5: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
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
Secondary IDs:
Open or close this module Study Status
Record Verification: July 2015
Overall Status: Not yet recruiting
Study Start: December 2015
Primary Completion: December 2018 [Anticipated]
Study Completion:
First Submitted: July 31, 2015
First Submitted that
Met QC Criteria:
July 31, 2015
First Posted: August 4, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 31, 2015
Last Update Posted: August 4, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Anthera Pharmaceuticals
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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 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).
Detailed Description:
Open or close this module Conditions
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
Lupus
Lupus Erythematosus, Systemic
Autoimmune Diseases
A-623
Blisibimod
Nephritis
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 350 [Anticipated]
Open or close this module Arms and Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Proportion of responders to the SRI-6 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 to ≤ 7.5 mg
[ 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 counts, anti-dsDNA, C3, C4
[ Time Frame: Through week 52 ]

8. Number of adverse events
[ Time Frame: Through week 52 ]

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

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Monica Gangal
Telephone: 510-856-5600 Ext. 5574
Email: mgangal@anthera.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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