A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 13
- 主要终点
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to LY3462817 and LY3509754
研究概览
简要总结
This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. The study will last up to one year and one month for each participant. As part of protocol addendum, this study is additionally evaluating the safety and tolerability of LY3509754 in participants with psoriasis. Blood tests will be done to check how much LY3509754 is in the bloodstream and how long the body takes to get rid of it. The addendum will last up to 12 weeks for each participant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have been diagnosed with psoriasis for at least 6 months
- •Participants must have active psoriasis plaques
- •Participants must be willing and able to have skin biopsies (small samples of skin removed for testing)
排除标准
- •Participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (Day 1)
- •Participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline
研究组 & 干预措施
LY3462817 - Intravenous (IV)
LY3462817 administered as IV infusions.
干预措施: LY3462817 - IV (Drug)
Placebo - IV
Placebo administered as IV infusions.
干预措施: Placebo - IV (Drug)
LY3462817 - Subcutaneous (SC)
LY3462817 administered as SC injections. (SC administration is discretionary/optional.)
干预措施: LY3462817 - SC (Drug)
Placebo - SC
Placebo administered as SC injections. (SC administration is discretionary/optional.)
干预措施: Placebo - SC (Drug)
LY3509754
LY3509754 administered orally.
干预措施: LY3509754 (Drug)
Placebo
Placebo administered orally.
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 LY3462817 and LY3509754
时间窗: Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
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): Average Concentration (Cave) of LY3462817 and LY3509754(Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754))