A Study of LY3361237 in Participants With Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Randomized, Placebo-Controlled, Multiple- Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3361237 in Patients With Systemic Lupus Erythematosus

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Drug: LY3361237
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3361237<br>LY3361237 administered subcutaneously (SC) | Drug: LY3361237<br>* Administered SC<br>|
| Placebo Comparator: Placebo<br>Placebo administered SC | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | PK: AUC Over the Dosing Interval of LY3361237 | Day 1 predose through Day 155 |