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 6 to 11 Years Old) With Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 17
- 主要终点
- Plasma Concentration of the Roflumilast Major N-oxide Metabolite
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 6 to 11 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
- 6 Years 至 11 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, and, if age appropriate, assent by the subject, as required by local laws.
- •Males or females, 6 to 11 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).
- •Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the duration of the trial and for one week after application of the last dose.
- •Females of non-childbearing potential must be pre-menarchal.
- •In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis.
- •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
- •Subjects with a CDI-2 (parent report) raw score >20 at Screening/Baseline
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 the Roflumilast Major N-oxide Metabolite
时间窗: Predose on Days 14 and 28
Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study.
Number of Participants With Application Site Reactions
时间窗: Baseline (Day 1), Day 7, and Day 14
The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product.
Plasma Concentration of ARQ-151 Cream 0.3%
时间窗: Predose on Days 14 and 28
Plasma levels of circulating roflumilast were determined at 2 points in the study.
Number of Participants With ≥1 Adverse Event (AE)
时间窗: Up to 28 days
The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
次要结局
未报告次要终点