研究单位：[1]Merck Sharp & Dohme LLC[2]PPD, Part of Thermo Fisher Scientific[3]Digestive Health Specialists ( Site 0135),Dothan,Alabama,United States,36301[4]IMC-Gulf Coast Gastroenterology ( Site 0157),Fairhope,Alabama,United States,36532[5]Research Solutions of Arizona ( Site 3816),Litchfield Park,Arizona,United States,85340[6]GI Alliance - Sun City ( Site 0103),Sun City,Arizona,United States,85351[7]Southern California Research Center ( Site 3828),Coronado,California,United States,92118[8]UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0113),La Jolla,California,United States,92037[9]Clinnova Research - Orange ( Site 3803),Orange,California,United States,92868[10]University of Colorado Anschutz Medical Campus-Division of Gastroenterology and Hepatology ( Site 01,Aurora,Colorado,United States,80045[11]Peak Gastroenterology Associates ( Site 0116),Colorado Springs,Colorado,United States,80907[12]Connecticut Clinical Research Institute ( Site 0126),Bristol,Connecticut,United States,06010[13]Medical Research Center of Connecticut ( Site 0151),Hamden,Connecticut,United States,06518[14]Gastroenterology Consultants of Clearwater ( Site 0152),Clearwater,Florida,United States,33756[15]University of Florida College of Medicine-Gastroenterology ( Site 3821),Gainesville,Florida,United States,32610[16]Nature Coast Clinical Research - Inverness ( Site 3806),Inverness,Florida,United States,34452[17]Orlando Health ( Site 0145),Orlando,Florida,United States,32806[18]Atlanta Gastroenterology Associates - Peachtree Dunwoody ( Site 0115),Atlanta,Georgia,United States,30342[19]Atlanta Center for Gastroenterology ( Site 0155),Decatur,Georgia,United States,30033[20]GI Alliance - Glenview ( Site 0168),Glenview,Illinois,United States,60026[21]GI ALLIANCE - GURNEE ( Site 0107),Gurnee,Illinois,United States,60031[22]Iowa Digestive Disease Center ( Site 0123),Clive,Iowa,United States,50325[23]Baton Rouge General Medical Center - Bluebonnet ( Site 0112),Baton Rouge,Louisiana,United States,70809[24]Tulane University School of Medicine-Gastroenterology and Hepatology ( Site 0154),New Orleans,Louisiana,United States,70112[25]University of Michigan ( Site 0143),Ann Arbor,Michigan,United States,48109[26]Clinical Research Institute of Michigan, LLC ( Site 0108),Clinton Township,Michigan,United States,48038[27]Clinical Research Institute of Michigan, LLC ( Site 0150),Troy,Michigan,United States,48098[28]Washington University School of Medicine ( Site 0129),Saint Louis,Missouri,United States,63110[29]Circuit Clinical /Middletown Medical PC ( Site 3831),Middletown,New York,United States,10940[30]New York Gastroenterology Associates ( Site 0159),New York,New York,United States,10128[31]Carolina Digestive Diseases and Endoscopy Center ( Site 3809),Greenville,North Carolina,United States,27834[32]University Gastroenterology ( Site 0164),Providence,Rhode Island,United States,02904[33]Gastroenterology Associates of Orangeburg ( Site 0149),Orangeburg,South Carolina,United States,29118[34]Vanderbilt Inflammatory Bowel Disease Clinic ( Site 0131),Nashville,Tennessee,United States,37204[35]Quality Medical Research ( Site 3807),Nashville,Tennessee,United States,37211[36]GI Alliance - Garland ( Site 0109),Garland,Texas,United States,75044[37]The University of Texas Health Science Center at Houston-Internal Medicine-Division of Gastroentero,Houston,Texas,United States,77030[38]Clinical Trial Network ( Site 3819),Houston,Texas,United States,77074[39]GI Alliance - Lubbock ( Site 0167),Lubbock,Texas,United States,79410[40]Caprock Gastro Research ( Site 0101),Lubbock,Texas,United States,79424[41]GI Alliance: Mansfield ( Site 0161),Mansfield,Texas,United States,76063[42]CARTA - Clinical Associates In Research Therapeutics Of America ( Site 0122),San Antonio,Texas,United States,78212[43]Southern Star Research Institute ( Site 0106),San Antonio,Texas,United States,78229[44]GI Alliance - San Marcos ( Site 0130),San Marcos,Texas,United States,78666[45]GI Alliance - Southlake ( Site 0104),Southlake,Texas,United States,76092-9167[46]Tyler Research Institute ( Site 0105),Tyler,Texas,United States,75701[47]Texas Digestive Disease Consultants ( Site 0136),Webster,Texas,United States,77598[48]Velocity Clinical Research, Salt Lake City ( Site 3801),West Jordan,Utah,United States,84088[49]Washington Gastroenterology - Bellevue ( Site 3844),Bellevue,Washington,United States,98004-4631[50]Washington Gastroenterology - Tacoma ( Site 0102),Tacoma,Washington,United States,98405[51]Centro de Investigaciones Médicas Mar del Plata ( Site 2101),Mar del Plata,Buenos Aires,Argentina,7600[52]CER medical Institute-Gastroenterology ( Site 2110),Quilmes,Caba,Argentina,B1878DVB[53]Hospital Provincial del Centenario ( Site 2108),Rosario,Santa Fe,Argentina,S2002KDS[54]C.I.C.E. 9 de Julio-CICE 9 DE JULIO ( Site 2103),San Miguel de Tucumán,Tucuman,Argentina,T4000IKO[55]Mater Misericordiae Limited-Gastroenterology ( Site 2506),Brisbane,Queensland,Australia,4101[56]Medizinische Universität Wien-Klinik für Innere Medizin III - Abteilung für Gastroenterologie und H,Vienna,Wien,Austria,1090[57]Toronto Immune & Digestive Health Institute ( Site 0005),Toronto,Ontario,Canada,M6A 3B4[58]Diex Recherche Quebec Inc. ( Site 0008),Quebec,Canada,G1V 4T3[59]Clinical Research Chile SpA ( Site 2201),Valdivia,Los Rios,Chile,5110683[60]First Affiliated Hospital of Kunming Medical University
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
