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ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1

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研究单位: [1]Abivax S.A. [2]Digestive Health Specialists of the Southeast,Dothan,Alabama,United States,36305 [3]Lakeview Clinical Research,Guntersville,Alabama,United States,35976 [4]GI Alliance,Sun City,Arizona,United States,85351 [5]Del Sol Research Management, LLC,Tucson,Arizona,United States,85715 [6]University of Arizona,Tucson,Arizona,United States,85724 [7]University of Arkansas for Medical Sciences,Little Rock,Arkansas,United States,72205-7199 [8]Aurora Care Clinic,Costa Mesa,California,United States,92627 [9]Gastro Care Institute,Lancaster,California,United States,93534 [10]California Medical Research Associates Inc.,Northridge,California,United States,91324 [11]Clinnova Research Solutions,Orange,California,United States,92868 [12]Peak Gastroenterology Associates,Colorado Springs,Colorado,United States,80907 [13]Clinical Research Of Brandon, LLC,Brandon,Florida,United States,33511 [14]Access Research Institute,Brooksville,Florida,United States,34613 [15]Auzmer Research,Lakeland,Florida,United States,33813 [16]Cfagi, Llc,Maitland,Florida,United States,32751 [17]MedOne Clinical Research LLC,Miami,Florida,United States,33145 [18]Medical Professional Clinical Research Center,Miami,Florida,United States,33165 [19]Advanced Research Institute, Inc.,New Port Richey,Florida,United States,34653 [20]Endoscopic Research, Inc.,Orlando,Florida,United States,32803 [21]Advanced Research Institute, Inc.,Orlando,Florida,United States,32825 [22]Gastroenterology Associates of Pensacola, PA,Pensacola,Florida,United States,32503 [23]Theia Clinical Research Centers, LLC,Temple Terrace,Florida,United States,33617 [24]Digestive Healthcare of Georgia,Atlanta,Georgia,United States,30309 [25]Atlanta Center for Gastroenterology, P.C.,Decatur,Georgia,United States,30033 [26]One Health Research Clinic Atlanta, LLC,Norcross,Georgia,United States,30093 [27]Northwestern University Feinberg School of Medicine,Chicago,Illinois,United States,60611 [28]Eagle Clinical Research,Chicago,Illinois,United States,60621 [29]GI Alliance,Glenview,Illinois,United States,60026 [30]GI Alliance,Gurnee,Illinois,United States,60031 [31]Indiana University School of Medicine,Indianapolis,Indiana,United States,46202 [32]University of Kansas Medical Center Research Institute, Inc.,Kansas City,Kansas,United States,66160 [33]University of Louisville Research Foundation,Louisville,Kentucky,United States,40202 [34]GI Alliance - Baton Rouge,Baton Rouge,Louisiana,United States,70809 [35]Boston Medical Center,Boston,Massachusetts,United States,02118 [36]Lucida Clinical Trials LLC,New Bedford,Massachusetts,United States,02740 [37]Digestive Health Center PA,Ocean Springs,Mississippi,United States,39564 [38]University of Nebraska Medical Center,Omaha,Nebraska,United States,68198 [39]Dartmouth-Hitchcock Medical Center,Lebanon,New Hampshire,United States,03766 [40]AGA Clinical Research Associates, LLC,Egg Harbor Township,New Jersey,United States,08234 [41]Rochester Clinical Research,Rochester,New York,United States,14609 [42]Charlotte Gastroenterology and Hepatology, P.L.L.C,Charlotte,North Carolina,United States,28207 [43]Care Access Research Lumberton,Lumberton,North Carolina,United States,28358 [44]Wilmington Health,Wilmington,North Carolina,United States,28401 [45]Gastro Health Research,Cincinnati,Ohio,United States,45249 [46]Wexner Medical Center,Columbus,Ohio,United States,43210 [47]DSI Research LLC,Springboro,Ohio,United States,45066 [48]Columbia Digestive Health Research,Columbia,South Carolina,United States,29204 [49]Gastroenterology Associates, PA,Greenville,South Carolina,United States,29607 [50]Gastroenterology Center of the MidSouth PC,Germantown,Tennessee,United States,38138 [51]GI Alliance - Southlake,Austin,Texas,United States,76092 [52]Central Texas Clinical Research, LLC,Austin,Texas,United States,78705 [53]Texas Digestive Disease Consultants,Cedar Park,Texas,United States,78613 [54]Baylor Scott and White,Dallas,Texas,United States,75246 [55]Cook Children's Medical Center,Fort Worth,Texas,Unit

研究目的:
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission 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].

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