A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 432
- 试验地点
- 49
- 主要终点
- Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8
研究概览
简要总结
This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.
详细描述
This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle foam is applied once daily for 8 weeks to 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
- •For adult subjects: Participants legally competent to read, write, and sign and give informed consent. For adolescent subjects: Informed consent of a parent(s) or legal guardian, and assent by the subjects, as required by local laws.
- •Males and females ages 12 years and older (inclusive) at the time of consent or assent.
- •Scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least Moderate ('3') at Baseline.
- •Extent of scalp psoriasis involving ≥ 10% of the total scalp at Baseline.
- •A Psoriasis Scalp Severity Index (PSSI) of at least 6 at Baseline.
- •An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Baseline.
- •A PASI score of at least 2 (excluding palms and soles) at Baseline.
- •Clinical diagnosis of psoriasis vulgaris of at least 6 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
- •Total overall psoriasis involvement on scalp and non-scalp areas ≤ 25% BSA (not including palms/soles) at Baseline. Total non-scalp BSA should not exceed 20%.
- •Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and 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 or a barrier method of contraception throughout the study according to Contraception Requirements for the protocol.
- •Females of non-childbearing potential must either be premenarchal, post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization according to Contraception Requirements for the protocol. Prepubescent females must agree to be abstinent during the study.
- •Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
排除标准
- •Subjects who cannot discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the Baseline visit and during the study.
- •Planned excessive exposure to treated area(s) to either natural or artificial sunlight, tanning bed, or other LED.
- •Previous treatment with ARQ-151 or ARQ-
- •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 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.
- •Any condition that in the Investigator's assessment would preclude the subject from participating in the study.
研究组 & 干预措施
Roflumilast Foam 0.3%
Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% once daily (qd) for 8 weeks.
干预措施: Roflumilast Foam 0.3% (Drug)
Vehicle Foam
Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.
干预措施: Vehicle Foam (Drug)
结局指标
主要结局
Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8
时间窗: Week 8
The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8
时间窗: Week 8
The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.
次要结局
- Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2(Week 2)
- Achievement of SI-NRS Success at Week 4(Week 4)
- Achievement of SI-NRS Success at Week 8(Week 8)
- Change From Baseline in SI-NRS Score at Day 1(Day 1)
- Change From Baseline in SI-NRS Score at Day 3(Day 3)
- Change From Baseline in SI-NRS Score at Week 1(Week 1)
- Achievement of WI-NRS (Worst Itch-Numeric Rating Score) Success at Week 8(Week 8)
- Achievement of a 75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)(Week 8)
- Change From Baseline in Psoriasis Symptoms Diary (PSD) Aggregate Score of Itching, Pain, and Scaling (Questions 1, 9, and 11)(Week 8)
- Percentage of Participants Achieving PSD Itching (Question 1) Score of 0 at Week 8(Week 8)
- Percentage of Participants Achieving PSD Pain (Question 9) Score of 0 at Week 8(Week 8)
- Percentage of Participants Achieving PSD Scaling (Question 11) Score of 0 at Week 8(Week 8)
- Percentage of Participants Achieving PSD Total Score of 0 at Week 8(Week 8)
- Achievement of a 75% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI) Score (PSSI-75)(Week 8)
- Achievement of S-IGA Score of 'Clear' at Week 8(Week 8)
- Achievement of S-IGA Success at Week 2(Week 2)
- Achievement of S-IGA Success at Week 4(Week 4)
- Change From Baseline in PASI Score at Week 2(Week 2)