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A Phase II Study in Adult Patients With Moderate to Severe Atopic Dermatitis

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研究单位: [1]Reistone Biopharma Company Limited [2]Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital Tianjin,Tianjin,China,300120 [3]Xuanwu Hospital Capital Medical University Beijing,China,100053 [4]Peking University Third Hospital Beijing,China,100083 [5]Peking union medical college hospital Beijing,China,100730 [6]Beijing Tsinghua Changgeng Hospital Beijing,China,102218 [7]The Second Xiangya Hospital of Central South University Changsha,China,410008 [8]Xiangya Hospital of Central South University Changsha,China,410008 [9]The Third Xiangya Hospital of Central South University Changsha,China,410013 [10]Second Affiliated Hospital of Army Medical University (Xinqiao Hospital) Chongqing,China,400037 [11]The First Affiliated Hospital of Fujian Medical University Fuzhou,China,350005 [12]Guangdong Provincial People's Hospital Guangzhou,China,510000 [13]Sun. Yat- Sen Memorial Hospital,Sun. Yat- Sen University Guangzhou,China,51000 [14]The first affiliated hospital Zhejiang university Hangzhou,China,310003 [15]Affiliated Hangzhou first people's hospital,Zhejiang university school of medicine Hangzhou,China,310006 [16]Zhejiang province People's Hospital Hangzhou,China,310014 [17]Jinan Central Hospital Jinan,China,250013 [18]Shanghai Skin Disease Hospital Shanghai,China,200050 [19]The first hospital of China medical university Shenyang,China,110001 [20]The First Affiliated Hospital of Soochow University Suzhou,China,215006 [21]The First Hospital of Shanxi Medical University Taiyuan,China,030001 [22]Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology Wuhan,China,430022 [23]Henan provincial people's hospital Zhengzhou,China,450003

研究目的:
This proposed study is a randomized, double-blind, placebo-controlled, 3-arm parallel, multicenter phase II study, designed to explore the efficacy and safety of SHR0302 treatment for patients with moderate to severe atopic dermatitis. The study will be conducted over a 12-week treatment period. Two active doses of SHR0302 will be compared to placebo and improvement in atopic dermatitis will be assessed using the Investigator's Global Score (IGA)

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