An Open Label, Phase 1, Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% Administered QD in Pediatric Participants With Scalp and Body Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 5
- 主要终点
- Concentration of Roflumilast and Roflumilast N-Oxide from plasma
研究概览
简要总结
This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
详细描述
ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis.
The goal of the study is to:
- Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%.
- Assess the safety and tolerability of ARQ-154 foam 0.3%
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ages 2 years to < 12 years old at Day
- •Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator.
- •Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day
- •An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day
- •Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day
- •Body psoriasis (non-scalp) involving at least 3% BSA on Day 1.
排除标准
- •Participants who cannot discontinue medications and treatments prior to Day 1 (first application of IP).
- •Current diagnosis of non-plaque forms of psoriasis. Current diagnosis of drug-induced psoriasis.
- •Participants who have significant active systemic or localized infection or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days prior to Day
- •Participants with skin conditions other than psoriasis vulgaris that would interfere with evaluations of the effect of the study medication, as determined by the Investigator.
- •Participants who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Day 1 and during the study period.
- •A medical history of severe renal insufficiency, moderate to severe hepatic disorders (e.g., Child-Pugh B or C), or chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).
- •Participants who are family members of the clinical study staff or sponsor.
研究组 & 干预措施
ARQ-154 Foam 0.3%
ARQ-154 foam 0.3% will be applied QD. Treatment duration will be up to 6 weeks, including 2 weeks under maximal usage conditions, followed by an optional 4 weeks under non-maximal usage conditions.
干预措施: ARQ-154 Foam 0.3% (Drug)
结局指标
主要结局
Concentration of Roflumilast and Roflumilast N-Oxide from plasma
时间窗: 2 Weeks
Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration.
Participant incidence of adverse events
时间窗: 6 Weeks
Number of participants with adverse events during treatment will be assessed
Incidence of application site reactions
时间窗: 6 Weeks
Number of participants that experience an application site skin reaction by investigator assessment and participant assessment will be assessed
The incidence of changes from Baseline in the total Children's Depression Inventory 2 (CDI-2)score.
时间窗: 6 Weeks
The CDI-2 is an assessment instrument used to evaluate the severity of depressive symptoms in children.
次要结局
未报告次要终点