Open Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis
详细描述
This is a 4-week open-label study in which subjects will be assigned to receive tapinarof cream, 1% once daily for 4 weeks. At the end of the 4-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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects age 2 to 17 with a confirmed clinical diagnosis of atopic dermatitis and present for at least 6 months for ages 6-17 years old, 3 months for ages 2-5 years old
- •BSA involvement ≥ 25% for subjects ages 12-17 years old, or ≥ 35% for subjects ages 2-11 years old, suitable for topical therapy.
- •vIGA-AD score of ≥ 3 at screening and baseline (pre-dose)
- •Female subjects of child bearing potential who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
- •Capable of giving written informed consent
- •Negative pregnancy test at Baseline (Day 1)
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 (DMVT-505) cream, 1% applied topically once daily
干预措施: Tapinarof cream, 1% (Drug)
结局指标
主要结局
Number of Participants That Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline to Day 28 for subjects enrolling in Long-Term Extension (LTE), otherwise to Day 35
Number of Participants that Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs).
Change From Baseline in Laboratory Values (U/L)
时间窗: Baseline to Day 28
Change in laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (g/L)
时间窗: Baseline to Day 28
Change in laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (mmol/L)
时间窗: Baseline to Day 28
Change in laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (Umol/L)
时间窗: Baseline to Day 28
Change in laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (10^9 Cells/L)
时间窗: Baseline to Day 28
Change in laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (%)
时间窗: Baseline to Day 28
Change in laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (pg)
时间窗: Baseline to Day 28
Change in Ery. mean corpuscular hemoglobin laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (fL)
时间窗: Baseline to Day 28
Change in Ery. mean corpuscular volume laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (10^12 Cells/L)
时间窗: Baseline to Day 28
Change in Erythrocytes laboratory values was assessed for clinical relevance
Change From Baseline in Laboratory Values (L/L)
时间窗: Baseline to Day 28
Change in Hematocrit laboratory values was assessed for clinical relevance
Mean Change in Local Tolerability Scale (LTS)
时间窗: Baseline to Day 28
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale. 0 indicates no irritation and 4 indicates Very Severe irritation.
Tapinarof Plasma PK Parameters on Day 1: AUC0-τ
时间窗: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.
Tapinarof Plasma PK Parameters on Day 1: Cmax
时间窗: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.
Tapinarof Plasma PK Parameters on Day 1: Tmax
时间窗: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.
Tapinarof Plasma Concentration: Cτ
时间窗: Day 1 (PK samples collected pre-dose and at 1, 3, and 5 hours post-dose)
The Cτ is a pharmacokinetic parameter that is the last quantifiable concentration determined directly from individual concentration-time data
Change From Baseline in Vital Signs (Beats/Min)
时间窗: Baseline to Day 28
Change in pulse vital signs was assessed for clinical relevance
Change From Baseline in Vital Signs (mmHg)
时间窗: Baseline to Day 28
Change in Blood Pressure vital signs was assessed for clinical relevance
Change From Baseline in Vital Signs (C)
时间窗: Baseline to Day 28
Change in Temperature vital signs was assessed for clinical relevance
次要结局
- Change From Baseline in Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD)(Baseline to Day 28)
- Number of Subjects Who Have a Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Score of Almost Clear (0 or 1) and at Least a 2-grade Reduction From Baseline(Baseline to Day 28)
- Number of Subjects With ≥50%, Improvement in Eczema Area and Severity Index (EASI) Score(Baseline to Day 28)
- Number of Subjects With ≥75%, Improvement in Eczema Area and Severity Index (EASI) Score(Baseline to Day 28)
- Number of Subjects With ≥90%, Improvement in Eczema Area and Severity Index (EASI) Score(Baseline to Day 28)
- Mean Change in Eczema Area and Severity Index EASI From Baseline to Day 28(Baseline to Day 28)
- Percent Change in Eczema Area and Severity Index EASI From Baseline to Day 28(Baseline to Day 28)
- Mean Change in Percent of Total Body Surface Area (%BSA) Affected(Baseline to Day 28)
- Percent Change in Percent of Total Body Surface Area (%BSA) Affected(Baseline to Day 28)
- Mean Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values(Baseline to Day 28)
- Percent Change in Total Body Surface Area (BSA) x Validated Investigator Global Assessment in Atopic Dermatitis (vIGA-AD) Values(Baseline to Day 28)
- Mean Change in Average Weekly Peak Pruritus Numerical Rating Scale (PP-NRS) Score(Baseline to Day 28)
- Proportion of Subjects With a Baseline Peak Pruritus Numerical Rating Scale (PP-NRS) Score ≥4 Who Achieved ≥4-point Reduction in PP-NRS Score(Baseline to Day 28)