Lupus Erythematosus, Systemic
Conditions
Brief summary
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.
Interventions
DRUGLY3361237
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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: * Azathioprine ≤200 mg/day * Antimalarial (e.g., chloroquine, hydroxychloroquine, quinacrine) * Mycophenolate mofetil ≤2 g/day or mycophenolic acid ≤1.44 grams per day (g/day) * Oral, SC, or intramuscular methotrexate ≤15 milligrams per week (mg/week)
Exclusion criteria
* Participants must not have a history of, or current, inflammatory joint or skin disease other than SLE * Participants must not have a current active bacterial, viral, or fungal infection * Participants must not have evidence of significant liver or kidney dysfunction * Participants must not have received cytotoxic medications (e.g., cyclophosphamide) within the last 3 months. * Participants must not have received any intra-articular, intramuscular, or intravenous glucocorticoids within the last 3 months * Participants must not have received blood products (e.g., blood transfusion, platelets, etc.) within the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline through Day 155 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237 | Day 1 predose through Day 155 | PK: Cmax of LY3361237 |
| PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237 | Day 1 predose through Day 155 | PK: AUC Over the Dosing Interval of LY3361237 |
Countries
United States
Outcome results
None listed