A Pilot Study of an Oral Phosphodiesterase Inhibitor (Apremilast) for Atopic Dermatitis in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Change in EASI Scores
研究概览
简要总结
The purpose of this study is to obtain preliminary data regarding the safety and tolerability of apremilast in AD to support the design of larger controlled studies.
详细描述
To investigate the preliminary safety and efficacy of apremilast, an oral phosphodiesterase 4 inhibitor, for atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Disease severity of Moderate, Severe, or Very Severe by Investigator Global Assessment.
- •Disease severity must be greater than or equal to 6 on the Rajka-Langeland Severity Scoring system corresponding to moderate-severe disease.
- •Baseline EASI score must be greater than or equal to
- •A previous validation study for the EASI scoring system revealed patients with moderate to very severe disease had mean EASI scores ranging from 11-
- •Candidate for, or previously on systemic therapy, including cyclosporine, methotrexate, or other immunosuppressant and treatment with ultraviolet light. Specifically, subjects are considered candidates for systemic therapy when their disease is not adequately controlled using topical therapies or side-effects prevent the further safe use of topical therapies.
- •Subjects must meet the washout requirements
排除标准
- •History of active mycobacterial infection with any species (including Mycobacterium tuberculosis) within 3 years prior to screening visit. Subjects with Mycobacterium tuberculosis infection more than 3 years prior to screening visit are allowed if successful treatment was completed at least 3 years prior to randomization and is documented and available for verification.
- •At least 3 major bacterial infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years.
- •Clinically significant abnormality on the chest X-ray (CXR) at screening. Chest X-rays performed within 3 months prior to start of study drug are acceptable.
- •Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer).
- •Any clinically significant abnormality on 12-lead ECG (electrocardiogram) at screening.
- •History of congenital or acquired immunodeficiency (e.g., Common Variable Immunodeficiency [CVID]).
- •Hepatitis B surface antigen positive or Hepatitis B core antibody positive at screening.
- •History of Human Immunodeficiency Virus (HIV) infection.
- •Antibodies to Hepatitis C at screening.
- •History of squamous cell carcinoma of the skin and thin melanoma.
- •Systemic corticosteroid-dependent asthma.
- •Active infection of any type at the time of enrollment.
研究组 & 干预措施
20 mg BID
Patients dosed with 20 mg orally of Apremilast BID for 3 months.
干预措施: Apremilast (Drug)
30 mg BID
Patients dosed with 30 mg orally of Apremilast BID for 6 months.
干预措施: Apremilast (Drug)
结局指标
主要结局
Change in EASI Scores
时间窗: Mean change in EASI score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm)
The eczema area and severity index (EASI) is a composite score measuring physical signs of atopic dermatitis. The scale ranges from 0-72. The components measuring severity are four signs/symptoms of atopic dermatitis: erythema, population, excoriation and lichenification on a scale of 0-3 for each body of the four body regions (head/neck, trunk, arms, legs). The component measuring area is a body surface area measurement of each region. The area and severity of each body region is weighted based on size of region which are added together for the complete score. The score for each patient's with scores between 0 and 7 are considered mild ,between 7 and 21 are considered moderate, and greater than 21 are considered severe. In this study the change in EASI score between baseline and month three (end of study) in the 20 mg arm and month six in the 30 mg arm, baseline EASI score was subtracted from month 3 or month 6 score in the 30mg arm,and calculated as a final outcome data point.
次要结局
- Change in Pruritus (Visual Analog Scale) Score(Mean change in Pruritus (Visual Analog Scale) score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm))
- Change In DLQI Scores(Mean change in DLQI scores measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm))
- Number of Participants in Each IGA Category(Mean change in IGA score measured at Baseline and Month 3, (if on 20mg arm) or Baseline and Month 6 (if on 30mg arm))
研究者
Eric Simpson
Associate Professor, Dermatology
Oregon Health and Science University