Use of Apremilast in Patients Who Are Dissatisfied With Stable Maintenance Topical Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16
研究概览
简要总结
Sixteen week open label study of apremilast in combination with topical steroids with a four week safety follow up visit.
详细描述
This is an open label, 16 week study of apremilast in combination with topical corticosteroids (TCS). Twenty qualified subjects will be enrolled. Visits will consist of Baseline, 8 week, 16 week and a 20 week safety follow up after 4 weeks off treatment. Subjects will dose with apremilast as per label. Topical corticosteroids (TCS) will be used for up to Week 4 as per label and then will be used on an as needed basis until Week 16. Assessments will include Static Physicians Global Assessment (sPGA), Psoriasis Area Severity Index (PASI), Psoriatic Body Surface Area (BSA), Dermatology Life Quality Index (DLQI),Assessment of Pruritus, Patient Satisfaction questionnaire. and Patient Global Assessment (PtGA)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be in general good health as judged by investigator
- •Female of childbearing potential (FCBP) must have a negative pregnancy test at screening and Baseline.
- •FCBP must use an approved method of contraception as outlined in the protocol.
- •Male subjects who engage in activity in which conception is possible must use barrier contraception as defined in the protocol.
- •18 years of age or older
- •Understand and voluntarily sign the Informed Consent
- •Able to adhere to study visit schedule
- •Moderate plaque type psoriasis as define by a a PGA of 3
- •BSA 0f 5-10% or a DLQI score of 7 or more
- •History of uncontrolled plaque psoriasis after either stable dose of high potency topical steroids for 2 weeks or mid-potency steroids for 4 weeks within the last 6 months
排除标准
- •Any clinically significant disease as determined by the investigator or major disease that is currently uncontrolled
- •Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk
- •Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years
- •Pregnant or breastfeeding, FCBP who are not willing to use acceptable birth control methods.
- •Active substance abuse or a history of substance abuse within 6 months prior to screening.
- •Malignancy or history of malignancy except fo treated (cured) basal cell or or squamous cell in situ skin carcinomas, treated (cured) cervical intraepithelial neoplasia or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years
- •Has not completed the prescribed washout for restricted treatments
- •Known or suspected allergy to investigational product
- •Other types of psoriasis
- •Prior history of depression
- •Prior use of apremilast
研究组 & 干预措施
Apremilast
Apremilast, 30 mg. tablets, two times a day for 16 weeks
干预措施: Apremilast (Drug)
结局指标
主要结局
Mean Change in Product of BSA (Body Surface Affected by Psoriasis) and sPGA (Static Physician Global Assessment) From Baseline to Week 16
时间窗: Week 16
The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) of disease severity is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0 (no disease) and 500 (most severe disease) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.
Percent Change in Product of BSA and sPGA
时间窗: Week 16
The area of body surface affected by psoriasis (BSA) will be estimated by the Investigator as a percentage of the subject's total body surface area wherein the area of the subject's palm will be considered as 1% of total BSA. Static Physician Global Assessment (sPGA) is measured by the Investigator on a 6-point scale wherein 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe. The product of these values offers a more specific assessment of the severity of psoriasis. This product can yield a result between 0(no disease) and 500 (most severe disease.) By reporting the percent change as well as the absolute value change, the reader may be better able to appreciate the impact on disease severity of the medication under study.
次要结局
- Percent Change in Product of BSA and sPGA(Week 8)
- Mean Change in DLQI(Week 16)
- Mean Change in Pruritus Scores(Baseline to Week 16)
- Mean Change in BSA(Week 16)
- Proportion of Patients Who Achieve PASI 50(Week 16)
- Percent Change in BSA(Baseline to Week 16)
- Proportion of Patients Who Achieve PASI 75(Week 16)
- % of Patients Achieving Clear or Almost Clear on the PtGA(Week 16)