NCT04875169已完成3 期
A Randomized, Double Blind and Placebo Controlled Phase 3 Study to Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 336
- 试验地点
- 70
- 主要终点
- Investigator's Global Assessment (IGA) score of 0/1 at Week 16
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic dermatitis.
详细描述
This study consists of a screening period followed by a placebo-controlled treatment period and then an extension treatment period and completed after a follow-up period after the completion of active treatment.
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
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects must be at least at ≥12 and ≤75 years of age and body weight ≥40 kg
- •Subject has a diagnosis of atopic dermatitis for at least 1 year.
- •Meets all of the following disease activity criteria: BSA ≥10% of AD involvement. EASI ≥
- •Subject has a recent history (within 6 months before the screening visit) of inadequate response or inability to tolerate topical AD treatments (TCS or TCI) or who have required systemic treatments for control of their disease.
- •Are willing to discontinue certain treatments for eczema (such as systemic and topical treatments during a washout period).
排除标准
- •Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- •Have received certain treatments that are contraindicated.
- •Subject currently has been diagnosed and has active forms of other inflammatory skin disease (e.g., psoriasis, or lupus erythematosus) that would interfere with the evaluation of atopic dermatitis or response to treatment.
- •Other active non-AD inflammatory skin diseases or conditions affecting skin
- •Subject with active/severe concomitant disease (s)/symptom(s) that requires administering of systemic corticosteroids or otherwise interferes with study participation or requires active frequent monitoring (e.g., unstable chronic asthma).
- •Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation.
- •Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
- •Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
- •Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
- •Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
- •Subject has a previously received systemic JAK inhibitors
- •Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
结局指标
主要结局
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
时间窗: 16 Weeks
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16.
Eczema Area and Severity Index (EASI 75) at Week 16
时间窗: 16 Weeks
Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16.
次要结局
- Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16(Week 16)
- Worst-Itch Numeric Rating Scale (WI-NRS) at Week 1, 4, 8 and 12(Week 1, 4, 8 and 12)
- EASI 75 at Week 1, 4, 8 and 12(Week 1, 4, 8 and 12)
- Time to WI-NRS response(Baseline to Week 16)
- IGA 0/1 at Week 1, 4, 8 and 12(Week 1, 4, 8 and 12)
研究者
研究点 (70)
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