A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 88
- 主要终点
- Monitoring of vital signs tests
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.
详细描述
This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.
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)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of atopic dermatitis based on the criteria of the Japanese Dermatological Association and have: pruritus (itching); eczema-like changes in a typical pattern, and a chronic or chronically relapsing course.
- •Childhood onset (under age of 13) of atopic dermatitis.
- •Diagnosis of moderate atopic dermatitis based on the Rajka Langeland score between 4.5 and 7.5, inclusive.
- •Have at least 3 ratings of "Moderate itching", "Severe itching", or "Extremely severe itching" either at night or during the day based on the Pruritus Categorical Response Scale (PCRS) in the 7 days prior to randomization.
- •Atopic dermatitis with 10% to 50% (inclusive) Body Surface Area (BSA) involvement.
排除标准
- •Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator's opinion. Patients with well controlled asthma, allergic rhinitis, or allergic conjunctivitis are allowed to participate. Atopic dermatitis patients with other chronic conditions will not be excluded if the Investigator has determined that the condition is not severe or progressive and is being controlled with stable therapy.
- •Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
- •Evidence of any other skin condition that, in the opinion of the Investigator, would interfere with the assessment of atopic dermatitis.
- •Use of non-steroid immunosuppressive or immunomodulatory agents within 4 weeks of randomization, including cyclosporine A, azathioprine, mycophenolate mofetil, and interferon gamma.
- •Use of systemic corticosteroids within 4 weeks of randomization.
研究组 & 干预措施
JNJ-39758979, 300 mg
干预措施: JNJ-39758979, 300 mg (Drug)
JNJ-39758979, 100 mg
干预措施: JNJ-39758979, 100 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Monitoring of vital signs tests
时间窗: Up to approximately 14 weeks
Blood pressure and pulse as a measure of safety
Monitoring of physical examination assessments
时间窗: Up to 10 weeks
Including height and body weight, as a measure of safety
Monitoring of clinical laboratory tests
时间窗: Up to approximately 14 weeks
Assessments of blood, serum, and urine as a meaure of safety
The number of adverse events
时间窗: Up to approximately 14 weeks
As a measure of safety
Monitoring of electrocardiograms
时间窗: Up to approximately 14 weeks
As a measure of safety
EASI (Eczema Area and Severity Index) score
时间窗: Up to approximately 14 weeks
A measure of the severity and extent of atopic dermatitis
次要结局
- Pruritus Categorical Response Scale (PCRS)(Up to approximately 14 weeks)
- Pruritus Interference Numeric Rating Scale (PINRS)(Up to approximately 14 weeks)
- Subject's Global Impressions of Change in Pruritus (SGICP)(Up to 10 weeks)
- Investigator's Global Assessment (IGA)(Up to approximately 14 weeks)
- Pruritus Numeric Rating Scales (PNRS)(Up to approximately 14 weeks)