A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of LY3041658 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 20
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
研究概览
简要总结
The reason for this study is to see if the study drug LY3041658 is effective in participants with moderate-to-severe hidradenitis suppurativa (HS).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of HS for at least 6 months
- •Have HS lesions in at least 2 different anatomic areas
- •Have inadequate response or intolerance to a 28 day course of oral antibiotics
- •Have a total count of abscesses and inflammatory nodules greater than or equal to 4
- •Agree to use a topical antiseptic daily
- •Agree to stop using topical antibiotics during the study. In certain cases, oral antibiotics will be allowed
排除标准
- •Have more than 20 draining fistulae
- •Have received any biologic medication (adalimumab, etc.) for the treatment of HS
- •Plan to use oral opioids for HS-related pain during the study
- •Uncontrolled depression or suicidal thoughts
研究组 & 干预措施
LY3041658
Participants received 600 mg LY3041658 administered intravenously (IV) once every 2 weeks (Q2W).
干预措施: LY3041658 (Drug)
Placebo
Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
干预措施: Placebo (Drug)
Placebo
Placebo administered IV. Participants will switch to 600 mg LY3041658 administered IV after week 16.
干预措施: LY3041658 (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
时间窗: Week 16
The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (sum of abscesses and inflammatory nodules \[AN count\]) with no increase in abscess count (A count) and no increase in draining fistulae count (DF count) relative to baseline. Non-responder imputation (NRI): Participants with missing data were considered non-responders.
次要结局
- Mean Change From Baseline to Week 16 in Skin Pain on the HS Numeric Rating Scale (NRS)(Baseline, Week 16)
- Mean Change From Baseline to Week 16 in Total Number of Abscesses and Inflammatory Nodules (AN) Count(Baseline, Week 16)