A Study of the Efficacy and Safety of Subcutaneous Blisibimod in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2015/002

Enrollment

Unknown

Registered

2015-01-20

Start date

2015-01-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Interventions

1. Study centres in Sri Lanka: • Sri Jayawardenapura General Hospital 2. Number of arms: 2 Participants randomized to the intervention arm will received Blisibimod 200mg by subcutaneous injection on

Eligibility

Inclusion criteria

Inclusion criteria: 1. Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology (in addition to criteria 2 and 3 below) 2. Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA) 3. Active SLE disease as defined by SELENA-SLEDAI score >10 despite on-going stable corticosteroid therapy 4. 18 years of age or older

Exclusion criteria

Exclusion criteria: 1. Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension or poorly controlled diabetes 2. Malignancy within past 5 years 3. Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C 4. Liver disease 5. Anemia, neutropenia, or thrombocytopenia 6. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections 7. History of active tuberculosis or a history of tuberculosis infection 8. Pregnant or nursing

Design outcomes

Primary

Measure	Time frame
Proportion of patients achieving an SLE Responder Index [a composite score derived from the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), the British Isles Lupus Assessment Group (BILAG) A and B scores and physicians global assessment] The primary endpoint variable is modified from SRI-8 to SRI-6 [53 weeks]	—

Secondary

Measure	Time frame
Time to first severe SLE flare [53 weeks] Proportion of subjects able to reduce oral steroid dose to >7.5 mg/day prednisone [53 weeks] Change in the number of actively tender or swollen joints and in mucocutaneous disease [53 weeks ] Change in proteinuria from baseline [53 weeks ] Proportion of subjects with improved patient-reported outcomes [53 weeks] Time to treatment [53 weeks ] Time to first renal flare [53 weeks ] Change from baseline in B cell subsets, anti dsDNA, C3, C4 [53 weeks ] Safety Profile (AEs, vital signs, labs, physical exams) [53 weeks ]	—

Measure

Time frame

Time to first severe SLE flare [53 weeks] Proportion of subjects able to reduce oral steroid dose to >7.5 mg/day prednisone [53 weeks] Change in the number of actively tender or swollen joints and in mucocutaneous disease [53 weeks ] Change in proteinuria from baseline [53 weeks ] Proportion of subjects with improved patient-reported outcomes [53 weeks] Time to treatment [53 weeks ] Time to first renal flare [53 weeks ] Change from baseline in B cell subsets, anti dsDNA, C3, C4 [53 weeks ] Safety Profile (AEs, vital signs, labs, physical exams) [53 weeks ]

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Countries

Belarus,Brazil,Colombia,Georgia,Guatemala,Hong Kong,Korea, Democratic People's Republic of,Malaysia,Mexico,Philippines,Russian Federation,Singapore,Sri Lanka,Thailand

Contacts

Public ContactDr. LalithSirimevanWijayaratne

Consultant Rheumatologist

lalithsw@sltnet.lk+94112692681

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026