A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS107G to Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.
研究概览
简要总结
This study will compare the safety and efficacy of Oral DS107 (2 g) to placebo in patients with moderate to severe atopic dermatitis.
Oral DS107 (2 g) will be orally administered for 8 weeks, and will be compared against placebo.
This study will enroll approximately 100 adult patients.
详细描述
Subjects will come to the clinic on 6 occasions: at screening, baseline, week 2, week 4, week 8 (end of treatment/early termination) and week 10 (follow-up). The primary efficacy variable will be the IGA. Secondary efficacy variables will include IGA (Investigator's Global Assessment), SCORAD (Scoring Atopic Dermatitis) Visual Analog Scale (VAS), EASI, BSA (Body Surface Area), POEM (Patient Orientated Eczema Measure), DLQI (Dermatology Life Quality Index).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subject aged 18 years and older.
- •Moderate to severe atopic dermatitis.
排除标准
- •Clinically significant impairment of renal or hepatic function.
- •History of hypersensitivity to any substance in Oral DS107 or placebo capsules.
- •Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline).
- •Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources and/or is planning a trip to sunny climate.
研究组 & 干预措施
Placebo
Placebo capsules matching Oral DS107 capsules
干预措施: Placebo (Drug)
Oral DS107 2g
Oral DS1072g, 4 x 500mg capsules administered orally once a day
干预措施: Oral DS107 (Drug)
结局指标
主要结局
Proportion of Patients Achieving an Investigator's Global Assessment (IGA) of 0 (Clear) or 1 (Almost Clear) and a Decrease of at Least 2 Points in IGA at Week 8.
时间窗: Week 8
The IGA is a global assessment of the current state of the disease. It is a 6-point morphological assessment of overall disease severity and will be determined according to the following definitions: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe) and 5 (very severe). The scale uses clinical characteristics of erythema, infiltration, papulation and oozing/crusting as scoring guidelines for the overall severity assessment. A decrease in IGA indicates a positive outcome for the participant.
次要结局
- Change From Baseline in IGA at Week 2, 4 and 8.(Baseline, Week 2, Week 4 and Week 8)
- Change From Baseline in Eczema Area and Severity Index (EASI) at Week 2, 4 and 8.(Baseline, Week 2, Week 4 and Week 8)
- Proportion of Patients Achieving at Least a 1-point Decrease in IGA at Week 8.(Up to 8 weeks.)
- Change From Baseline in the Patient Orientated Eczema Measure (POEM) at Week 2, 4 and 8.(Baseline, Week 2, Week 4 and Week 8)
- Change From Baseline in the Dermatology Life Quality Index (DLQI) Score at Week 2, 4 and 8.(Baseline, Week 2, Week 4 and Week 8)
- Change From Baseline in Scoring of Atopic Dermatitis (SCORAD) at Week 2, 4 and 8.(Baseline, Week 2, Week 4 and Week 8)
- Change From Baseline in the Patient's Visual Analog Scale (VAS) Pruritus Score at Week 2, 4 and 8.(Baseline, Week 2, Week 4 and Week 8)
- Change From Baseline in Body Surface Area (BSA) at Week 2, 4 and 8.(Baseline, Week 2, Week 4 and Week 8)
- Number of Participants With TEAEs in Each Treatment Group(Up to 14 weeks)