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Study halted prematurely and will not resume. Subjects were seen until February 2017
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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 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).
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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-6 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 |
|---|---|---|
| Occurrence of renal flare in subjects with renal manifestations at baseline | 52 Weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 004 | Tbilisi | 0102 | Georgia | |||
| Investigator Site 001 |
| 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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 10, 2018 | |
| Reset | May 9, 2018 | |
| Release | Jul 17, 2018 |
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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 to ≤ 7.5 mg | 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 counts, anti-dsDNA, C3, C4 | Through week 52 |
| Number of adverse events | Through week 52 |
| Tbilisi |
| 0179 |
| Georgia |
| Investigator Site 002 | Tbilisi | 0186 | Georgia |
| Reset | Aug 13, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 10, 2018 | May 9, 2018 | |||
| Jul 17, 2018 | Aug 13, 2018 |
| 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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