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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01395745
• Date of registration: 14/07/2011
• Prospective Registration: Yes
• Primary sponsor: Anthera Pharmaceuticals
• Public title: CHABLIS-SC1: A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus CHABLIS-SC1
• 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
• Date of first enrolment: February 2013
• Target sample size: 442
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01395745
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belarus, Brazil, Colombia, Georgia, Guatemala, Hong Kong, India, Korea, Republic of, Malaysia, Mexico, Philippines, Russian Federation, Singapore, Sri Lanka, Taiwan, Thailand

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

- 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



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

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: blisibimod

Drug: Placebo

Primary Outcome(s)

Proportion of patients achieving an SLE Responder Index at week 52 [Time Frame: Week 52]

Secondary Outcome(s)

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

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

Proportion of subjects able to reduce oral steroid dose to =7.5 mg/day prednisone [Time Frame: Week 52]

Safety Profile (AEs, vital signs, labs, physical exams) [Time Frame: Week 52]

Time to treatment failure [Time Frame: Week 52]

Change in the number of actively tender or swollen joints and in mucocutaneous disease activity [Time Frame: Week 52]

Time to first renal flare [Time Frame: Week 52]

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

Time to first severe SLE flare [Time Frame: Week 52]

Secondary ID(s)

AN-SLE3331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors