NCT05549947已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacokinetics of SHR-1819 Injection in Adults With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)
研究概览
简要总结
This trial was designed to evaluate the efficacy and safety of SHR-1819 injection in patients 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
- Single (Participant)
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
- •Subjects voluntarily sign informed consent forms prior to the commencement of any proceedings related to the study, are able to communicate smoothly with the investigator, understand and are willing to complete the study in strict compliance with the requirements of this clinical research protocol;
- •Age 18 to 75 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
- •Have atopic dermatitis at the time of screening (according to the 2014 American College of Dermatology Guidelines) and have a course of at least 1 year before screening;
- •At the screening and baseline periods, EASI ≥ 16, IGA ≥ 3, BSA ≥ 10%;
- •The average daily peak pruritus (itch) numerical evaluation scale (P-NRS) score for the first 7 days of randomization ≥ 4 points (at least 4 days of daily peak pruritus P-NRS scores need to be collected);
- •According to the investigators, topical TCS treatment was poor or intolerant within 6 months prior to screening.
排除标准
- •Pregnant or lactating women;
- •Major surgeries are planned for the duration of the study;
- •History of previous atopic corneal conjunctivitis involving the cornea;
- •History of clinically significant diseases (e.g., circulatory system abnormalities, endocrine system abnormalities, neurological disorders, hematologic disorders, immune system disorders, psychiatric disorders, and metabolic instability) that the researcher believes that participation in the study poses a risk to the safety of the subject or that the disease/illness worsens during the study period will affect the effectiveness or safety analysis;
- •Subjects have had or are currently clinically significant diseases or abnormalities;
- •Screening for people with a history of heavy alcohol consumption or substance abuse in the 3 months prior to screening;
- •The drug has been used in the previous 6 months;
- •Screening of subjects with malignancy within the first 5 years (except completely cured cervical cancer in situ and non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma);
- •Other comorbid (or co-occurring) skin disorders may be affected in the study evaluation;
- •Any cause that the researchers believe would prevent the participants from participating in the study.
研究组 & 干预措施
Treatment group D: placebo
Placebo Comparator
干预措施: Placebo (Drug)
Treatment group A: SHR-1819
Experimental
干预措施: SHR-1819 (Drug)
Treatment group B: SHR-1819
Experimental
干预措施: SHR-1819 (Drug)
Treatment group C: SHR-1819
Experimental
干预措施: SHR-1819 (Drug)
结局指标
主要结局
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥75% from baseline)
时间窗: up to 16 weeks
EASI sore use EASI scale
At 16 weeks, the proportion of subjects who achieved eczema area and severity index (EASI) -75 (EASI score decreased ≥ 75% from baseline)
时间窗: Up to 16 weeks
EASI sore use EASI scale
次要结局
- Changes in the level of CCL17 in the serum(From the beginning of administration to the 24th week)
- At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change.(up to 16 weeks)
- The concentration of SHR-1819 in serum :Cmax(From the beginning of administration to the 24th week)
- At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change(up to 16 weeks)
- At week 16, EASI is the percentage change from baseline and change;(up to 16 weeks)
- At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change(up to 16 weeks)
- At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥2 points;(up to 16 weeks)
- Changes in the level of TARC in the serum(From the beginning of administration to the 24th week)
- Immunogenic endpoint: evaluate the incidence and timing of ADA positivity for SHR-1819(From the beginning of administration to the 24th week)
- The concentration of SHR-1819 in serum :AUC(From the beginning of administration to the 24th week)
- Changes in the level of IgE in the serum(From the beginning of administration to the 24th week)
- At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥2 points from baseline(up to 16 weeks])
- The incidence of adverse events ranged from the first dose to 24 weeks(From the beginning of administration to the 24th week)
- At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥90% lower than baseline);(up to 16 weeks)
- At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥50% lower than baseline);(up to 16 weeks)
- At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥4 points(up to 16 weeks)
- The time of metabolism of the drug in the serum(From the beginning of administration to the 24th week)
- At week 16, the proportion of participants with an overall investigator assessment (IGA) score of 0 or 1 (0-4 scale) and a decrease of ≥ 2 points from baseline(Up to 16 weeks)
- At week 16, the proportion of subjects whose IGA score decreased from baseline by ≥ 2 points(Up to 16 weeks)
- At week 16, the proportion of subjects who achieved EASI-90 (EASI score ≥ 90% lower than baseline)(Up to 16 weeks)
- At week 16, the percentage of subjects who achieved EASI-50 (EASI score ≥ 50% lower than baseline)(Up to 16 weeks)
- At week 16, the weekly average of the daily peak itching (itch) digital evaluation scale (P-NRS) decreased from baseline by ≥ 4 points(Up to 16 weeks)
- At week 16, EASI is the percentage change from baseline and change(Up to 16 weeks)
- At week 16, the atopic dermatitis score (SCORAD) was the percentage change from baseline and change(Up to 16 weeks)
- At week 16, atopic dermatitis affects the body surface area (BSA) as a percentage of the baseline change and change(Up to 16 weeks)
- At week 16, the Dermatological Quality of Life Scale (DLQI) score was a percentage change from baseline and change(Up to 16 weeks)
- Concentration of SHR-1819 in serum(From the beginning of administration to the 24th week)
- Changes of TARC/CCL17 in the serum(From the beginning of administration to the 24th week)
- Changes of IgE in the serum(From the beginning of administration to the 24th week)
- Changes of eotaxin-3 in the serum(From the beginning of administration to the 24th week)
- Immunogenicity of SHR-1819(From the beginning of administration to the 24th week)
研究者
研究点 (1)
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