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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2015
• Main ID: NCT02074020
• Date of registration: 26/02/2014
• Prospective Registration: Yes
• Primary sponsor: Anthera Pharmaceuticals
• Public title: CHABLIS-SC2: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus With or Without Nephritis
• Scientific 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
• Date of first enrolment: December 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02074020
• 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
• Phase: Phase 3

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Placebo

Drug: Blisibimod

Primary Outcome(s)

Proportion of responders to the SRI-8 composite responder index [Time Frame: 52 Weeks]

Secondary Outcome(s)

Change in proteinuria from baseline [Time Frame: Week 52]

Time to treatment failure [Time Frame: Through week 52]

Proportion of subjects able to reduce oral steroid dose [Time Frame: Baseline through 52 weeks]

Change from baseline in B cell subsets, anti-dsDNA, C3, C4 [Time Frame: Through week 52]

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]

Proportion of subjects with improved patient-reported outcomes [Time Frame: Week 52]

Safety profile (AEs, vital signs, labs, physical exams) [Time Frame: Through week 52]

Secondary ID(s)

AN-SLE3332

Source(s) of Monetary Support

Please refer to primary and secondary sponsors