NCT04128007已完成2 期
A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 47
- 主要终点
- Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
研究概览
简要总结
This study will assess the safety and efficacy of ARQ-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis
详细描述
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws.
- •Males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents).
- •Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Mild ('2') at Baseline.
- •A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline.
- •A PASI score of at least 2 (excluding the palms and soles) at Baseline.
- •Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
- •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).
- •Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
- •Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
- •Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.
排除标准
- •Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
- •Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
- •Subjects currently taking lithium or antimalarial drugs.
- •Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).
- •Current diagnosis of non-plaque forms 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.
- •Known allergies to excipients in ARQ-
- •Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
- •Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
- •Subjects with PHQ-8 >/= 10 or modified PHQ-A >/= 10 at Screening or Baseline.
- •Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- •Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
- •Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of the investigational product.
- •Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
- •Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
- •Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
- •Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal, or antiviral agents within 7 days of Baseline/Day
- •Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.
研究组 & 干预措施
ARQ-154 foam 0.3%
Experimental
active
干预措施: Roflumilast foam 0.3% (Drug)
ARQ foam VehicleRQ-154 foam Vehicle
Placebo Comparator
placebo
干预措施: Vehicle foam (Drug)
结局指标
主要结局
Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
时间窗: Week 8
The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
次要结局
- Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8(Week 8)
- Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score(Baseline and Weeks 2, 4, 8)
- Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)(Week 8)
- Change From Baseline in Psoriasis Symptoms Diary (PSD) Score(Baseline and Weeks 4 and 8)
- Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score(Up to 8 weeks)
- Number of Participants Achieving PSSI-90(Baseline and Week 8)
研究者
研究点 (47)
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