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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 8
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
LY3361237
LY3361237 administered subcutaneously (SC)
干预措施: LY3361237 (Drug)
Placebo
Placebo administered SC
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
时间窗: 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
次要结局
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237(Day 1 predose through Day 155)
- PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237(Day 1 predose through Day 155)