An Open Label, 4-Week, Phase 2, Maximal Usage Pharmacokinetics and Safety Study of ARQ-151 Cream 0.3% Administered QD in Pediatric Subjects (Ages 2 to 5 Years Old) With Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 18
- 主要终点
- Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3%
研究概览
简要总结
This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) 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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of parent(s) or legal guardian.
- •Males or females, 2 to 5 years old (inclusive).
- •Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks.
- •Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles).
- •An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline.
- •Subject has adequate venous access for PK sampling in areas not involved by plaque psoriasis and not being treated with ARQ-151 (e.g., back of the hands).
- •In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs and hematology values.
- •Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and Visit Schedule, according to the judgment of the Investigator.
排除标准
- •Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- •Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris
- •Current diagnosis of non-plaque form of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
- •Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
- •Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period.
- •Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Baseline/Day 1 and during the study period.
- •Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
- •Subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the Baseline/Day 1 and during the study period according to the protocol.
- •Subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1.
研究组 & 干预措施
ARQ-151 cream 0.3%
Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks
干预措施: ARQ-151 cream 0.3% (Drug)
结局指标
主要结局
Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3%
时间窗: Weeks 2 and 4: 1 hour predose
The plasma concentration of roflumilast at Weeks 2 and 4 is reported.
Plasma Concentration of Major N-oxide Metabolite Following Daily Application of Roflumilast Cream 0.3%
时间窗: Weeks 2 and 4: 1 hour predose
The plasma concentration of the major N-oxide metabolite of roflumilast at Weeks 2 and 4 is reported.
Number of Participants With an Adverse Event (AE)
时间窗: Up to 4 weeks
The number of participants with an AE during the treatment period is reported. An AE is any untoward medical
Number of Participants With Application Site Reactions
时间窗: Up to 4 weeks
The number of subjects that experience an application site skin reaction by investigator assessment or application site reactions reported as AEs is reported.
次要结局
未报告次要终点