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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blisibimod | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blisibimod | Drug | Administered via subcutaneous injection once per week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of responders to the SRI-8 composite responder index | 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first severe SLE flare | Baseline through 52 weeks | |
| Change in the number of actively tender or swollen joints and in mucocutaneous disease activity | 52 Weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroup analyses of blisibimod effect in subjects with renal manifestations at baseline | 52 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33687069 | Derived | Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2. |
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| Placebo |
| Drug |
Administered via subcutaneous injection once per week |
|
| Change in proteinuria from baseline |
| Week 52 |
| Proportion of subjects able to reduce oral steroid dose | Baseline through 52 weeks |
| Proportion of subjects with improved patient-reported outcomes | Week 52 |
| Time to treatment failure | Through week 52 |
| Change from baseline in B cell subsets, anti-dsDNA, C3, C4 | Through week 52 |
| Safety profile (AEs, vital signs, labs, physical exams) | Through week 52 |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D001327 | Autoimmune Diseases |
| D009393 | Nephritis |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C573858 | AMG623 peptibody |
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