A Phase 3 Efficacy and Safety Study of Tapinarof for the Treatment of Moderate to Severe Atopic Dermatitis in Children and Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 2
- 主要终点
- Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.
研究概览
简要总结
This is a double-blind, randomized, vehicle controlled Phase 3 study to evaluate the efficacy and safety of topical tapinarof cream, 1% compared to vehicle control cream in pediatric and adult subjects with atopic dermatitis.
详细描述
This study is a 8-week double-blind, vehicle-controlled treatment study in which subjects will be randomized to receive tapinarof cream, 1% or vehicle cream once daily for 8 weeks. At the end of the 8-week study treatment, qualified subjects will have the option to enroll in an open-label, long-term extension study for an additional 48 weeks of treatment. Subjects who do not participate in the open-label, long-term extension study will complete a follow-up visit approximately one week after the end of treatment in this study.
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)
盲法说明
The investigator, study center staff, subject, and sponsor will be blinded to treatment assignment.
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ages 2 and above with clinical diagnosis of AD
- •Subject with atopic dermatitis covering ≥5% and ≤ 35% of the BSA
- •A vIGA-AD score of ≥3 at screening and baseline
- •An EASI score of ≥6 at screening and baseline
- •Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
- •Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
- •Must not be pregnant
- •Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent
排除标准
- •Immunocompromised at screening
- •Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
- •Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
- •Screening total bilirubin > 1.5x ULN
- •Current or chronic history of liver disease
- •Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- •Subjects who would not be considered suitable for topical therapy
- •Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
- •History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
- •Pregnant or lactating females
- •History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the -Investigator or Medical Monitor, contraindicates their participation
- •Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
研究组 & 干预措施
tapinarof cream
tapinarof cream, 1%, applied topically once daily
干预措施: tapinarof cream, 1% (Drug)
vehicle cream
vehicle cream, applied topically once daily
干预措施: vehicle cream (Drug)
结局指标
主要结局
Percent of Subjects Who Have a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Score of Clear or Almost Clear (0 or 1) With a Minimum 2-grade Improvement From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.
时间窗: Baseline to Week 8
The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is calculated as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease. Statistics are based on 100 imputed datasets.
次要结局
- Percent of Subjects With ≥ 75% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.(Baseline to Week 8)
- Mean Change in in Percent of Total Body Surface Area (%BSA) Affected From Baseline to Week 8.(Baseline to Week 8)
- Percent of Subjects With ≥ 90% Improvement in Eczema Area and Severity Index (EASI) From Baseline to Week 8. Analyses Were Done Using Multiple Imputation.(Baseline to Week 8)
- Percent of Subjects ≥ 12 Years Old With a Baseline Peak Pruritis-Numeric Rating Scale (PP-NRS) Score ≥ 4 Who Achieve ≥ 4-point Reduction in the Average Weekly PP-NRS From Baseline to Week 8.(Baseline to Week 8)