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This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 623 | Experimental | Single dose of AMG 623 administered as subcutaneous and intravenous doses |
|
| Placebo | Placebo Comparator | Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 623 | Drug | Single dose of AMG 623 administered as subcutaneous and intravenous doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | up to 70 days | |
| Incidence of abnormal clinically significant vital signs | up to 70 days | |
| Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results | up to 70 days | |
| Incidence of abnormal clinically significant ECG results | up to 70 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax | up to 70 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26290435 | Derived | Stohl W, Merrill JT, Looney RJ, Buyon J, Wallace DJ, Weisman MH, Ginzler EM, Cooke B, Holloway D, Kaliyaperumal A, Kuchimanchi KR, Cheah TC, Rasmussen E, Ferbas J, Belouski SS, Tsuji W, Zack DJ. Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials. Arthritis Res Ther. 2015 Aug 20;17(1):215. doi: 10.1186/s13075-015-0741-z. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo |
| Drug |
Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses |
|