A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 370
- 主要终点
- Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
研究概览
简要总结
The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.
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
- •Adult subjects ages 18 to 65 years
- •A diagnosis of atopic dermatitis (AD)
- •An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
- •Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
- •Subjects must be practicing acceptable birth control methods
排除标准
- •Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
- •Use of phototherapy or tanning beds within 6 weeks of screening
- •Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
- •Female subjects who are pregnant or breastfeeding
研究组 & 干预措施
Low dose ASB17061
Oral administration of low dose ASB17061 taken once daily for 28 consecutive days.
干预措施: 5 mg ASB17061 (Drug)
Middle dose ASB17061
Oral administration of middle dose ASB17061 taken once daily for 28 consecutive days.
干预措施: 10 mg ASB17061 (Drug)
High dose ASB17061
Oral administration of high dose ASB17061 taken once daily for 28 consecutive days.
干预措施: 20 mg ASB17061 (Drug)
Placebo
Oral administration of placebo taken once daily for 28 consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Investigator's Global Assessment (IGA) Responders at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
时间窗: Baseline up to 29 days after initial dose.
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA, which consists of a 6-point scale from a minimum of 0 and a maximum of 6. Higher scores indicate a worse outcome and lower scores indicate a better outcome. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease).
Number of Investigator's Global Assessment (IGA) Responders By Subgroup at Day 29 Following Treatment With ASB17061 Capsules or Placebo in Adults With Atopic Dermatitis
时间窗: Baseline up to 29 days after initial dose.
Participants with an IGA score of 0 or 1 were considered IGA responders. The investigator provided an overall assessment of disease severity using the IGA which consists of a 6-point scale from the minimum of 0 to a maximum of 6. Higher scores indicate increasing severity.. (0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease, 4 = severe disease; and 5 = very severe disease) and an overall assessment of the disease severity of the entire body using the Eczema Area and Severity Index (EASI). A composite index, the EASI has a minimum score of 0 (clear) and a maximum score of 72 (very severe); A value less than 15 indicates less severe, and 15 or greater indicates more severe. Lichenification was evaluated on a scale of 0 (none) as the minimum to 3 (severe) as the maximum, and the score of each body region was summed (0 to 12). A percent body surface area (BSA) involved less than 15 is less severe and 15 or greater more severe.
次要结局
- Mean Change From Baseline in Eczema Area and Severity Index Score (EASI) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29(Baseline up to 29 days after initial dose.)
- Mean Change From Baseline in The Percentage of Body Surface Area (BSA) Involved Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29(Baseline up to 29 days after initial dose.)
- Mean Change From Baseline in Pruritus Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29(Baseline up to 29 days after initial dose.)
- Mean Change From Baseline in Insomnia Score Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis at Day 29(Baseline up to 29 days after initial dose.)
- Plasma Concentrations of ASB17061 and ASB17584 Over Time Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis(Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.)
- Minimum Observed Plasma Concentration (Cmin) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis(Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.)
- Maximum Observed Plasma Concentration (Cmax) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Subjects With Atopic Dermatitis(Baseline (Day 1 Predose) up to Day 8, Day 15, and Day 22 at 0 to 2.5 hours, 2.5 to 5 hours, 5 to 10 hours, up to Day 29 at 24-32 hours postdose.)
- Average Plasma Concentration (Cavg) of ASB17061 and ASB17584 Following Treatment With ASB17061 Capsules in Adult Participants With Atopic Dermatitis(Baseline up to Predose, up to 0 to 2.5 hours, up to 2.5 to 5 hours, up to 5 to 10 hours, up to Day 29 (24-32 hours).)
- Number of Participants With Treatment Emergent Adverse Events (TEAE) Following Treatment With ASB17061 Capsules or Placebo in Adult Participants With Atopic Dermatitis(Baseline up to Day 57 follow-up visit post dose.)