研究单位：[1]UZ Leuven, Belgium[2]Mount Sinai Health System Digestive Disease Institute, New York USA[3]Abivax S.A.[4]University of Alabama -Birmingham,Birmingham,Alabama,United States,35233[5]Digestive Health Specialists of the Southeast,Dothan,Alabama,United States,36305[6]Lakeview Clinical Research,Guntersville,Alabama,United States,35976[7]Research Solutions of Arizona, PC,Litchfield Park,Arizona,United States,85340[8]Valleywise Health Medical Center,Phoenix,Arizona,United States,85008[9]GI Alliance,Sun City,Arizona,United States,85351[10]Del Sol Research Management, LLC,Tucson,Arizona,United States,85715[11]University of Arizona,Tucson,Arizona,United States,85724[12]University of Arkansas for Medical Sciences,Little Rock,Arkansas,United States,72205-7199[13]Applied Research Center of Arkansas,Little Rock,Arkansas,United States,72212[14]National Institute of Clinical Research,Bakersfield,California,United States,93309[15]Kindred Medical Institute for Clinical Trials, LLC,Corona,California,United States,92879[16]Aurora Care Clinic,Costa Mesa,California,United States,92627[17]Citrus Valley Gastroenterology,Covina,California,United States,91723[18]University of California (San Diego),La Jolla,California,United States,92093[19]Gastro Care Institute,Lancaster,California,United States,93534[20]United Medical Doctors,Murrieta,California,United States,92563[21]Hoag Memorial Hospital Presbyterian,Newport Beach,California,United States,92663[22]California Medical Research Associates Inc.,Northridge,California,United States,91324[23]Clinnova Research Solutions,Orange,California,United States,92868[24]Clinical Applications Laboratories,San Diego,California,United States,92103[25]Kaiser Foundation Research Institute, a Division of Kaiser Permanente Hospitals,Aurora,Colorado,United States,80014[26]Peak Gastroenterology Associates,Colorado Springs,Colorado,United States,80907[27]Danbury Hospital,Danbury,Connecticut,United States,06810[28]Medical Research Center of Connecticut, LLC,Hamden,Connecticut,United States,06518[29]Clinical Research Of Brandon, LLC,Brandon,Florida,United States,33511[30]Access Research Institute,Brooksville,Florida,United States,34613[31]West Central Gastroenterology d/b/a Gastro Florida,Clearwater,Florida,United States,33762[32]Nature Coast Clinical Research, LLC,Inverness,Florida,United States,34452[33]I.H.S Health, LLC,Kissimmee,Florida,United States,34741[34]Auzmer Research,Lakeland,Florida,United States,33813[35]Cfagi, Llc,Maitland,Florida,United States,32751[36]Wellness Clinical Research,Miami Lakes,Florida,United States,33016[37]Infinite Clinical Research Inc,Miami,Florida,United States,33133[38]Research Associates of South Florida, LLC,Miami,Florida,United States,33134[39]University of Miami,Miami,Florida,United States,33136[40]MedOne Clinical Research LLC,Miami,Florida,United States,33145[41]Nicklaus Children''s Hospital,Miami,Florida,United States,33155-3009[42]Sanchez Clinical Research, Inc,Miami,Florida,United States,33157[43]Medical Professional Clinical Research Center,Miami,Florida,United States,33165[44]Reliant Medical Research, LLC,Miami,Florida,United States,33165[45]Ocala GI Research,Ocala,Florida,United States,34471[46]Sarkis Clinical Trials - Parent,Ocala,Florida,United States,34474[47]Endoscopic Research, Inc.,Orlando,Florida,United States,32803[48]Arnold Palmer Hospital For Children,Orlando,Florida,United States,32806[49]Omega Research Orlando, LLC,Orlando,Florida,United States,32808[50]Advanced Research Institute, Inc.,Orlando,Florida,United States,32825[51]Gastroenterology Associates of Pensacola, PA,Pensacola,Florida,United States,32503[52]Advanced Research Institute, Inc.,Saint Petersburg,Florida,United States,33710[53]Genesis Clinical Research,Tampa,Florida,United States,33606[54]GCP Clinical Research, LLC,Tampa,Florida,United States,33609[55]Guardian Angel Research Center,Tampa,Florida,United States,33614[56]Alliance Clinical Research,Tampa,Florida,United States,33615[57]Digestive Healthcare of Georgia,Atlanta,Georgia,United States,30309[58]Atlanta Center for Gastroenterology, P.C.,Decatur,Georgia,United States,30033[59]One Health Research Clinic Atlanta, LLC,Norcross,Georgia,United States,30093[60]Northwestern University Feinberg School of Medicine,Chicago,Illinois,United States,60611[61]First Affiliated Hospital of Kunming Medical University,Kunming,Yunnan,China,650032
研究目的：
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active ulcerative colitis who have inadequate response, no response, a loss of response, or an intolerance to either conventional therapies [corticosteroids, immunosuppressant (i.e. azathioprine, 6-mercaptopurine, methotrexate)] and/or advanced therapies [biologics (TNF inhibitors, anti-integrins, anti-IL-23), and/or S1P receptor modulators, and/or JAK inhibitors]. This study is the maintenance phase of both previous induction studies ABX464-105 and ABX464-106.
