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)