A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SCD-044 IN THE TREATMENT OF MODERATE TO SEVERE ATOPIC DERMATITIS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 58
- 主要终点
- Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.
研究概览
简要总结
To determine the effect of SCD-044 treatment on moderate to severe atopic dermatitis, as measured by proportion of subjects showing at least 75% improvement in Eczema Area and Severity Index (EASI) at Week 16.
详细描述
This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged at least 18 years.
- •Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
- •Moderate to severe atopic dermatitis at Screening and Baseline
排除标准
- •Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study.
- •Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.
- •History or presence of uveitis
结局指标
主要结局
Proportion of Subjects Who Achieve ≥75% Overall Improvement in Eczema Area and Severity Index (EASI) Score From Baseline to Week 16.
时间窗: Week16
Based on gross morphological findings, scores will be assigned on a 4-point scale \['0' (absent), '1' (mild), '2' (moderate) and '3' (severe)\] for each clinical sign. The information presented represents the percentage of subjects, calculated as the proportion of subjects multiplied by 100.
次要结局
- Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, vIGA Scale and ≥2 Point Reduction From Baseline to Week 16.(Week 16)
- Proportion of Subjects Who Achieve SCORing Atopic Dermatitis (SCORAD) 50 and SCORAD 75 Response at Week 32(Week 32)
- Percent Change From Baseline in Body Surface Area (BSA) With Atopic Dermatitis(Week 32)
- Percent Change in Mean Eczema Area and Severity Index (EASI) Score(Week 32)
- Proportion of Subjects Who Achieve Score of '0' (Clear) or '1' (Almost Clear) on a 5-point, Validated Investigator's Global Assessment (vlGA) Scale and ≥2 Point Reduction From Baseline.(Week 32)
- Change From Baseline in Quality of Life Measured by Dermatology Life Quality Index (DLQI) Scores.(Week 32)
- Proportion of Subjects Who Achieve ≥4-point Improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) From Baseline.(Week 32)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) Score(Week 32)
- Proportion of Subjects With Improvement in Patient Global Impression of Change (PGIC) Score(Week 32)
- Patient Global Impression of Severity (PGIS) of Disease Score(Week 32)
- Adverse Events.(Week 36)
研究者
Vasu Sadashivam
Scientific
Sun Pharmaceutical Industries Limited