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| ID | Type | Description | Link |
|---|---|---|---|
| I9S-MC-BTAB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to learn more about the safety of LY3361237 and any side effects that might be associated with it when given to participants with systemic lupus erythematosis (SLE). LY3361237 will be administered by injections just under the skin. The study will last up to 26 weeks and may include up to 17 visits to the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3361237 | Experimental | LY3361237 administered subcutaneously (SC) |
|
| Placebo | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3361237 | Drug | Administered SC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 155 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 | PK: Cmax of LY3361237 | Day 1 predose through Day 155 |
| PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237 |
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Inclusion Criteria:
Participants must have received a diagnosis of SLE at least 24 weeks before screening (at least 4 of 11 criteria in 1997 revised American College of Rheumatology [ACR] classification)
If a participant is taking oral prednisone (or prednisone equivalent) for SLE, the dose must be ≤20 milligrams per day (mg/day) for at least 8 weeks prior to screening, and must have been stable for at least the last 2 weeks
If a participant is taking any of the following medications for SLE, the medication must have been used for at least 12 weeks and stable for at least the last 8 weeks:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | United States | ||
| Clinical Research of West Florida |
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| Label | URL |
|---|---|
| A Study of LY3361237 in Participants With Systemic Lupus Erythematosus | 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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| Drug |
Administered SC |
|
PK: AUC Over the Dosing Interval of LY3361237
| Day 1 predose through Day 155 |
| Clearwater |
| Florida |
| 33765 |
| United States |
| Clinical Research of West Florida | Tampa | Florida | 33606 | United States |
| North Georgia Rheumatology, PC | Lawrenceville | Georgia | 30046 | United States |
| DJL Clinical Research, PLLC | Charlotte | North Carolina | 28210 | United States |
| Paramount Medical Research | Middleburg Heights | Ohio | 44130 | United States |
| Altoona Center For Clinical Research | Duncansville | Pennsylvania | 16635 | United States |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | United States |
| Accurate Clinical Management LLC - Katy | Houston | Texas | 77084 | United States |