A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3972406 in Adults With Moderate-to-Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 12
- 主要终点
- Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)
研究概览
简要总结
The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have moderate-to-severe chronic plaque psoriasis for at least 6 months prior to baseline
- •Have venous access sufficient to allow for blood sampling
- •Are able to swallow oral medication
- •Agree to skin biopsies
排除标准
- •Have any other skin conditions, excluding plaque psoriasis
- •Have a current or recent acute, active infection
- •Have manifestations of other autoimmune diseases, such as systemic lupus erythematosus.
- •Are lactating or breastfeeding women
研究组 & 干预措施
LY3972406
Participants received an oral dose of LY3972406 for 12 weeks.
干预措施: LY3972406 (Drug)
Placebo
Participants received an oral dose of placebo for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)
时间窗: Week 12
* The PASI is an investigator-administered, multi-item scale used to measure the severity of psoriasis based on lesion severity and the percent of body surface area (BSA) affected. * Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomical regions: head, trunk, upper limbs, lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement). * The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity. * The nonresponder imputation (NRI) method was used to handle missing data.
次要结局
- Change From Baseline in Percent Body Surface Area (BSA)(Baseline, Week 12)
- Change From Baseline in Dermatology Life Quality Index (DLQI)(Baseline, Week 12)
- Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406(Predose at Week 12)