Open-Label Maximal Use Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs
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 adults with plaque psoriasis.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study
- •BSA involvement ≥ 20%
- •PGA score of ≥ 3 at screening
- •Females of child bearing potential and male subjects 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
排除标准
- •Psoriasis other than plaque variant
- •Any sign of infection of any of the psoriatic lesions
- •Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with the interpretation of the results
- •Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
- •Use of any prohibited medication within the indicated period before the first dose of study drug
- •Pregnant females or lactating females
- •The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
- •Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
- •Previous known participation in a clinical study with tapinarof
研究组 & 干预措施
Tapinarof (DMVT-505) cream, 1%
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 With Clinically Significant Changes From Baseline in Laboratory Values, Biomarker Values, ECG Results or Vital Signs
时间窗: Baseline to Week 4 or Follow-Up (7-10 days after Week 4 Visit)
Changes in laboratory values, biomarker values, ECG results and vital signs were assessed for clinical relevance.
Number of Participants That Experienced Adverse Events (AEs), Severe Adverse Events, and Serious Adverse Events (SAEs)
时间窗: Baseline to Week 4
Frequency and severity of AEs (local and systemic)
Number of Participants With Irritation as Assessed by the Local Tolerability Scale
时间窗: Day 1, Day 15, Day 29
At each specified study visit, the Investigator (or qualified evaluator) assessed the presence and overall degree of irritation at the application sites, according to the LTS. The score will ideally represent an 'average' across all application sites. To the fullest extent possible, the same Investigator (or designated evaluator) will perform all tolerability assessments for an individual participant throughout the study.
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Cmax
时间窗: Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)
The Cmax is a pharmacokinetic parameter that describes the highest concentration of the drug that is achieved after dosing.
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: AUCo-tau
时间窗: Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)
The AUC in plasma is a pharmacokinetic parameter that describes the overall exposure of the drug.
Tapinarof and Tapinarof Sulfate (Metabolite) Plasma PK Parameters on Day 1 and Day 29: Tmax and t1/2
时间窗: Day 1 and Day 29 (PK samples collected at pre-dose and at 1, 2, 3, 4, 5, 8, 12, and 24 hours after dosing)
The tmax is a pharmacokinetic parameter that describes the time point at which the highest concentration of the drug is achieved after dosing.
次要结局
- Analysis of the Relationship Between Plasma Concentration and ΔQTcF(Day 1)
- Change From Baseline in QTcF (ΔQTcF) at Each Post-treatment Time Point on the Sampling Day With the Higher Cmax (Day 1 or Day 29)(Baseline and Day 1)
- Mean Change From Baseline to Day 29 in Physician's Global Assessment (PGA)(Baseline to Day 29)
- Mean Change From Baseline to Day 29 Psoriasis Area and Severity Index (PASI)(Baseline to Day 29)
- Mean Change From Baseline to Day 29 in Percent of Total Body Surface Area (%BSA) Affected(Baseline to Day 29)