JPRN-jRCT2080223488未知1 期
A Phase 1, Open-Label, Multiple-Dose Study of KHK4083 in Subjects with Atopic Dermatitis
Kyowa Hakko Kirin Co., Ltd.0 个研究点目标入组 20 人开始时间: 2017年3月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Voluntary written informed consent to participate in the study
- •2) Atopic dermatitis diagnosed according to the Definition and Diagnostic Criteria for Atopic Dermatitis (Guidelines for Management of Atopic Detmatitis 2016) established by the Japanese Dermatological Association
- •3) Moderate or severe (>=4.5) symptoms of atopic dermatitis at screening, according to the Rajka & Langeland Severity Index
- •4) IGA >=3 (moderate) at screening
排除标准
- •1) Any of the following clinically significant concurrent illnesses:
- •- Type 1 diabetes
- •- Poorly controlled type 2 diabetes (HbA1c >8.5%)
- •- Congestive heart failure (class II to IV of the New York Heart Association classification)
- •- Myocardial infarction within 1 year
- •- Unstable angina pectoris within 1 year
- •- Poorly controlled hypertension (systolic pressure >150 mm Hg or diastolic pressure >90 mm Hg at screening)
- •- Severe chronic lung diseases requiring oxygen therapy
- •- Multiple sclerosis or other demyelinating diseases
- •- Active malignancies, or onset or a history of treatment of malignancies within 5 years prior to informed consent (expept for resected or surgically cured epithelial carcinoma of the uterine cervix, cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, or ductal carcinoma)
- •2) Current or past history of clinically significant cardiovascular, liver, renal, respiratory, hematologic, central nervous system, psychiatric, or autoimmune diseases/disorders other than those in 1)
- •3) Alcohol dependence, or drug dependence or a positive result for any of the drug abuse test items
- •4) Past or current history of drug allergy
- •5) Any clinically significant infection requiring hospitalization or IV administration of antibiotics within 8 weeks prior to pre-enrollment
- •6) Any planned surgical treatment during the study
- •7) Any skin disease that may affect the clinical symptom assessment
- •8) Pregnant or lactating women, or women willing to have a child during the study period
研究者
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