研究单位：[1]Reistone Biopharma Company Limited[2]Reistone Pharma[3]Wellness Clinical Research, LLLC-Central Florida,Lake Wales,Florida,United States,33853[4]West Central Gastroenterology d/b/a Gastro Florida,Tampa,Florida,United States,33626[5]Digestive Disease Specialists, Inc.,Oklahoma City,Oklahoma,United States,73112[6]Guangdong Provincial People's Hospital,Guangzhou,Guangdong,China,510000[7]The First Affiliated Hospital, Sun Yat-sen University,Guangzhou,Guangdong,China,510080[8]Henan Provincial People's Hospital,Zhengzhou,Henan,China,453000[9]Baotou Central Hospital,Baotou,Inner Mongalia,China,014040[10]Liaocheng People's Hospital,Liaocheng,Shandong,China,252000[11]Peking University Shougang Hospital,Beijing,China,100041[12]Peking University Third Hospital,Beijing,China,100191[13]The First Affiliated Hospital of Bengbu Medical College,Bengbu,China,233004[14]The First Hospital of Jillin University,Changchun,China,130021[15]Xiangya Hospital Central South University,Changsha,China,410008[16]West China Hospital Sichuan University,Chengdu,China,610041[17]Fujian Provincial Hospital,Fuzhou,China,350001[18]The Sixth Affiliated Hospital of Sun Yat- Sen University,Guangzhou,China,510655[19]Sir Run Run Shaw Hospital,Hangzhou,China,310016[20]Huaian First People's Hospital,Huai'an,China,223300[21]Huzhou Central Hospital,Huzhou,China,313000[22]Qilu Hospital of Shandong University,Jinan,China,250012[23]The First People's Hospital of Lianyungang,Lianyungang,China,222061[24]Jiangsu Province Hospital,Nanjing,China,210006[25]Nanjing First Hospital,Nanjing,China,210006[26]Nanjing Drum Tower Hospital,Nanjing,China,210008[27]Zhongda Hospital Southeast University,Nanjing,China,210009[28]Pingxiang People's Hospital,Pingxiang,China,337000[29]Shanghai East Hospital,Shanghai,China,200000[30]Ruijin Hospital, Shanghai Jiaotong University School of Medicine,Shanghai,China,200025[31]Renji Hospital, Shanghai Jiaotong University School of Medicine,Shanghai,China,200127[32]The First Hospital of China Medical University,Shenyang,China,110001[33]The University of Hong Kong - Shenzhen Hospital,Shenzhen,China,518000[34]Shanxi Provincial People's Hospital,Taiyuan,China,030001[35]Second Hospital of Shanxi Medical University,Taiyuan,China,030012[36]Tianjin Union Medical Center,Tianjin,China,300000[37]The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China,325000[38]Tongji Hospital Affiliated to Tongji Medicine College,Wuhan,China,430030[39]Renmin Hospital of Wuhan University,Wuhan,China,430060[40]Yijishan Hospital of Wannan Medical College,Wuhu,China,241001[41]Indywidualma Specjalistyczna Praktyka Lekarska Maciej Zymla,Knurów,Poland,44-190[42]NZOZ Almedica,Nowy Targ,Poland,34400[43]SOLUMED Centrum Medyczne,Poznań,Poland,60-529[44]KO-MED Centra Kliniczne Plulawy,Puławy,Poland,24-100[45]Specjalistyczna Praktyka Lekarska dr med. Marek Horynski,Sopot,Poland,81-756[46]KO-MED Centra Kliniczne Staszow,Staszów,Poland,28-200[47]Twoja Przychodnia-Szczecinskie Centrum Medyczne,Szczecin,Poland,71434[48]Nzoz Formed,Wadowice,Poland,01868[49]Nzoz Formed,Wadowice,Poland,34100[50]Nzoz Vivamed,Warszawa,Poland,03-580[51]PlanetMed sp. z o.o.,Wrocław,Poland,53-333[52]Amicare Sp. z o.o. Sp.k,Łódź,Poland,90-644[53]IP Clinic,Łódź,Poland,90752[54]Wellness Clinical Research, LLC,Vega Baja,Puerto Rico,00694[55]RCI Chernivtsi Regional Clinical Hospital Dept of Gastroenterology Bukovinsky SMU,Chernivtsi,Ukraine,58002[56]I.I.Mechnykov Dnipropetrovsk Regional Clinical Hospital,Dnipro,Ukraine,49005[57]Central City Clinical Hospital Dept of Theraphy No. 2 SHEI Ivano-Frankivsk NMU,Ivano-Frankivs'k,Ukraine,76018[58]Ivana -Frankivsk Hospital,Ivano-Frankivs'k,Ukraine,76018[59]CHI Kharkiv City Clinical Hospital #13,Kharkiv,Ukraine,61124[60]CI Karabelesh Kherson CCH,Kherson,Ukraine,73000[61]Kherson City Clinical Hospital,Kherson,Ukraine,73000[62]Khmelnytska Regional Hospital,Khmelnytskyi,Ukraine,29000[63]Kyiv City Clinical Hospital #1,Kyiv,Ukraine,02091[64]Kyiv Railway Clinical Hospita
研究目的：
The proposed study is a randomized, double-blind,placebo-controlled, multicenter phase II study to investigate the safety and efficacy of SHR0302 in patients with moderate to severe active ulcerative colitis. The study aims to evaluate the optimal dose of SHR0302 and time needed to induce clinical response in active ulcerative colitis patients. This is an 8+8 weeks study, in which participants who complete the first 8 weeks treatment phase, will have the option to enter a blinded active arms 8-week extension phase. Early withdrawn subjects during the first treatment phase can not enter the extension phase. The total duration of the study participation, including extension and follow-up, will be approximately 18 weeks. SHR0302 is a Janus kinase 1(JAK1) inhibitor, capable of blocking Janus kinase-signal transducer and activator of transcription (JAK-STATs) pathway and controlling inflammation. Therefore it has the potential to be a treatment for ulcerative colitis.
