A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 8
- 主要终点
- Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
研究概览
简要总结
This study assessed the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s) (Cohort 1). The study also assessed the safety, PK and efficacy of ARQ-151 cream 0.5% vs vehicle and ARQ-151 cream 0.15% vs vehicle applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).
详细描述
There were 2 cohorts of participants. Cohort 1 was a single dose study of ARQ-151 0.5% cream applied to 25 cm^2 of psoriatic plaque(s) in 8 psoriasis participants. Cohort 2 was a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream was applied once a day for 28 days to participants with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Participants were adult (≥18 years old) males or females with chronic plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Cohort 1 was open label. Cohort 2 was double blind.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female participants aged ≥18 years.
- •In Cohort 1, participants must have at least 25 cm^2 of chronic plaque psoriasis (excluding the face, scalp, intertriginous areas, palms and soles).
- •In Cohort 2, participants must have 0.5% to 5.0% of total BSA of chronic plaque psoriasis and at least one target plaque, of at least 9 cm^2 in size with a TPSS ≥4 (excluding the face, scalp, intertriginous areas, palms and soles).
- •Women of childbearing potential must have a negative urine pregnancy test at Screening and agree to use birth control throughout the trial.
- •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.
- •Participants agree not to have prolonged sun exposure during the course of the study. Tanning bed use is not allowed.
- •Participants are competent to sign and give informed consent and considered reliable and capable of adhering to the Protocol and visit schedule.
排除标准
- •Participants with non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar psoriasis) or with drug-induced psoriasis.
- •Evidence of skin conditions other than psoriasis that would interfere with evaluation of the effect of the study medication.
- •Pregnant or lactating women or women planning to become pregnant during the study and / or within 28 days following the last dose of study medication.
- •Known allergies to excipients in ARQ-151 cream.
- •Participants who cannot discontinue the use of strong P-450 cytochrome inducers or inhibitors for two weeks prior to the baseline visit and during the study period.
- •Participants who are unwilling to refrain from using a tanning bed for 2 weeks before and during the study.
- •Participants who cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis.
- •Participants with a history of chronic alcohol or drug abuse in past 6 months.
- •History of and/or concurrent condition of serious hypersensitivity (anaphylactic shock or anaphylactoid reaction) to phosphodiesterase type 4 (PDE-4) inhibitors.
- •Current or a history of cancer within 5 years with the exception of fully excised skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
- •Participants with active infection that requires oral or intravenous administration of antibiotics, antifungal or antiviral agents.
- •Participants who are unable to communicate, read or understand language, or who display another condition which makes them unsuitable for clinical study participation.
研究组 & 干预措施
Cohort 1 - ARQ-151 cream 0.5%
Single-dose application of ARQ-151 cream 0.5% to 25 cm^2 of psoriatic plaque(s)
干预措施: ARQ-151 cream 0.5% (Drug)
Cohort 2 - ARQ-151 cream 0.5%
ARQ-151 cream 0.5% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
干预措施: ARQ-151 cream 0.5% (Drug)
Cohort 2 - ARQ-151 cream 0.15%
ARQ-151 cream 0.15% applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
干预措施: ARQ-151 cream 0.15% (Drug)
Cohort 2 - ARQ-151 vehicle cream
Vehicle cream applied daily for 28 days to all psoriatic plaques, not exceeding an application area of 5% BSA
干预措施: ARQ-151 vehicle cream (Drug)
结局指标
主要结局
Percent Change From Baseline in 4 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2
时间窗: Baseline and Week 4
Difference in least squares mean percent change from baseline at Week 4 in the product of target plaque severity score (TPSS) x target plaque area (TPA) between each dose concentration level of ARQ-151 cream and vehicle using mixed model repeated measures (MMRM) analysis with center within country, treatment, study visit, and treatment-by-study visit interaction as fixed effects and baseline TPSS x TPA score as a covariate. For TPSS, all target lesions were scored individually for signs of induration, scaling, and erythema using a 5-point severity scale: 0 = none; 1 = mild; 2 = moderate; 3 = severe; 4 = very severe. TPA (cm\^2) was determined by multiplying the longest diameter (cm) of the target plaque by the widest perpendicular diameter (cm) (perpendicular to the longest diameter of the target plaque). A negative percent change indicates improvement.
次要结局
- Percent Change From Baseline in Target Plaque Area in Cohort 2(Baseline and Weeks 1, 2, 3, and 4)
- Percent Change From Baseline in 1, 2, 3 Week Target Plaque Severity Score x Target Plaque Area in Cohort 2(Baseline and Weeks 1, 2 and 3)
- Percent Change From Baseline in Total Plaque Severity Score in Cohort 2(Baseline and Weeks 1, 2, 3, and 4)