[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561337":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":70,"studyPopulation":70,"armGroups":80,"interventions":93,"overallOfficials":106,"centralContacts":110,"locations":118,"responsibleParty":1893,"collaborators":70,"id":1895,"slug":70,"hasResults":1896,"nctId":1897,"briefTitle":1898,"officialTitle":1899,"acronym":1900,"eligibilityCriteria":1901,"healthyVolunteers":1896,"sex":1902,"minAge":1903,"maxAge":1904,"enrollmentInfo":1905,"targetDuration":70,"studyType":1908,"phases":1909,"briefSummary":1911,"conditions":1912,"keywords":70,"overallStatus":121,"whyStopped":70,"lastUpdateSubmitDate":1914,"lastUpdatePostDateStruct":1915,"startDateStruct":1918,"completionDateStruct":1920,"leadSponsor":1922,"locationsCount":1923},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":70},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants with Clinical Remission","Percentage of participants achieving Modified Mayo Score (mMS) \\\u003C=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.","At Week 12",[14,18,21,24,27,30,33,36,39,42,45,49,52,56,59,63,66],{"measure":15,"description":16,"timeFrame":17},"Change in Partial Modified Mayo Score (pmMS)","Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed).","From baseline to Week 2",{"measure":19,"description":20,"timeFrame":12},"Percentage of Participants with Endoscopic Improvement","Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12.",{"measure":22,"description":23,"timeFrame":12},"Percentage of Participants with Endoscopic Remission","Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.",{"measure":25,"description":26,"timeFrame":12},"Percentage of Participants with Clinical Response","Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS \\>= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease).",{"measure":28,"description":29,"timeFrame":12},"Percentage of Participants with Histologic Improvement","Percentage of participants achieving a histologic improvement, defined as Geboes \\\u003C=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).",{"measure":31,"description":32,"timeFrame":12},"Percentage of Participants with Histologic Remission","Percentage of participants achieving a histologic remission, defined as Geboes \\\u003C2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).",{"measure":34,"description":35,"timeFrame":12},"Participants with Histologic-Endoscopic Mucosal Improvement","Percentage of participants achieving Geboes \\\u003C= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).",{"measure":37,"description":38,"timeFrame":12},"Percentage of Participants with Histologic-Endoscopic Remission","Percentage of participants achieving Geboes \\\u003C 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).",{"measure":40,"description":41,"timeFrame":12},"Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants","Percentage of participants achieving mMS \\\u003C= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.",{"measure":43,"description":44,"timeFrame":12},"Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants","Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups.",{"measure":46,"description":47,"timeFrame":48},"Change in Bowel Urgency","Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).","Baseline through Week 12",{"measure":50,"description":51,"timeFrame":48},"Change in Abdominal Pain","Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).",{"measure":53,"description":54,"timeFrame":55},"Change in Fatigue","Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue.","Baseline to Week 12",{"measure":57,"description":58,"timeFrame":55},"Change in Health-Related Quality of Life","Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life.",{"measure":60,"description":61,"timeFrame":62},"Overall Change in UC Symptoms","Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from \"Much better\" to\"Much worse\".","Baseline to Week 2 and Week 12",{"measure":64,"description":65,"timeFrame":62},"Overall Severity in UC Symptoms","Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from \"None\" to \"Very severe\".",{"measure":67,"description":68,"timeFrame":69},"Incidence and Severity of Adverse Events (AEs)","Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.","Up to 30 Weeks after Baseline",null,{"allocation":72,"interventionModel":73,"interventionModelDescription":70,"primaryPurpose":74,"observationalModel":70,"timePerspective":70,"maskingInfo":75},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":76,"maskingDescription":70,"whoMasked":77},"DOUBLE",[78,79],"PARTICIPANT","INVESTIGATOR",[81,87],{"label":82,"type":83,"description":84,"interventionNames":85},"Afimkibart","EXPERIMENTAL","Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.",[86],"Drug: Afimkibart",{"label":88,"type":89,"description":90,"interventionNames":91},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo IV followed by placebo SC.",[92],"Drug: Placebo",[94,103],{"type":95,"name":82,"description":96,"armGroupLabels":97,"otherNames":98},"DRUG","Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.",[82],[99,100,101,102],"PF-06480605","RVT-3101","RG6631","RO7790121",{"type":95,"name":88,"description":104,"armGroupLabels":105,"otherNames":70},"Placebo matching IV afimkibart. Placebo matching SC afimkibart.",[88],[107],{"name":108,"affiliation":5,"role":109},"Clinical Trials","STUDY_DIRECTOR",[111,116],{"name":112,"role":113,"phone":114,"phoneExt":70,"email":115},"Reference Study ID Number: GA45330 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":117,"role":113,"phone":70,"phoneExt":70,"email":70},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[119,133,143,152,162,171,180,189,198,207,217,227,236,245,251,258,267,273,282,291,297,303,312,322,328,337,347,357,366,376,386,396,406,416,425,435,445,453,459,468,477,486,495,505,514,523,533,542,551,560,566,575,585,595,605,615,625,634,643,652,657,667,676,685,694,703,712,718,727,737,746,755,761,770,783,793,803,812,823,832,843,852,858,867,879,889,899,909,917,923,930,939,947,959,968,977,983,992,1002,1013,1025,1035,1044,1053,1062,1068,1077,1086,1095,1104,1113,1122,1131,1137,1146,1155,1164,1170,1181,1190,1200,1204,1213,1224,1235,1244,1253,1262,1271,1282,1291,1300,1311,1317,1326,1335,1344,1356,1362,1373,1379,1388,1398,1404,1409,1418,1429,1438,1450,1460,1466,1476,1485,1489,1498,1508,1520,1529,1540,1546,1550,1559,1568,1572,1576,1585,1594,1603,1612,1621,1627,1636,1645,1654,1660,1666,1670,1679,1690,1699,1708,1717,1726,1735,1746,1757,1768,1777,1789,1798,1803,1814,1825,1834,1838,1849,1858,1866,1875,1884],{"facility":120,"status":121,"city":122,"state":123,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":132,"contacts":70},"Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan","RECRUITING","Dothan","Alabama","36305","United States","US",{"type":128,"coordinates":129},"Point",[130,131],-85.39049,31.22323,{"lat":131,"lon":130},{"facility":134,"status":121,"city":135,"state":136,"zip":137,"country":125,"countryCode":126,"cosmosGeoPoint":138,"geoPoint":142,"contacts":70},"Mayo Clinic Hospital","Scottsdale","Arizona","85259",{"type":128,"coordinates":139},[140,141],-111.89903,33.50921,{"lat":141,"lon":140},{"facility":144,"status":121,"city":145,"state":136,"zip":146,"country":125,"countryCode":126,"cosmosGeoPoint":147,"geoPoint":151,"contacts":70},"Arizona Digestive Health, P.C (ADH)","Sun City","85351",{"type":128,"coordinates":148},[149,150],-112.27182,33.59754,{"lat":150,"lon":149},{"facility":153,"status":121,"city":154,"state":155,"zip":156,"country":125,"countryCode":126,"cosmosGeoPoint":157,"geoPoint":161,"contacts":70},"Om Research LLC","Apple Valley","California","92307",{"type":128,"coordinates":158},[159,160],-117.18588,34.50083,{"lat":160,"lon":159},{"facility":163,"status":121,"city":164,"state":155,"zip":165,"country":125,"countryCode":126,"cosmosGeoPoint":166,"geoPoint":170,"contacts":70},"Valley View Internal Medicine","Garden Grove","92845",{"type":128,"coordinates":167},[168,169],-117.94145,33.77391,{"lat":169,"lon":168},{"facility":172,"status":121,"city":173,"state":155,"zip":174,"country":125,"countryCode":126,"cosmosGeoPoint":175,"geoPoint":179,"contacts":70},"Gastro Care Associates","Lancaster","93534",{"type":128,"coordinates":176},[177,178],-118.13674,34.69804,{"lat":178,"lon":177},{"facility":181,"status":121,"city":182,"state":155,"zip":183,"country":125,"countryCode":126,"cosmosGeoPoint":184,"geoPoint":188,"contacts":70},"University of Southern California","Los Angeles","90033-1057",{"type":128,"coordinates":185},[186,187],-118.24368,34.05223,{"lat":187,"lon":186},{"facility":190,"status":121,"city":191,"state":155,"zip":192,"country":125,"countryCode":126,"cosmosGeoPoint":193,"geoPoint":197,"contacts":70},"Hoag Memorial Hospital Presbyterian;Hoag Center for Research and Education","Newport Beach","92663",{"type":128,"coordinates":194},[195,196],-117.92895,33.61891,{"lat":196,"lon":195},{"facility":199,"status":121,"city":200,"state":155,"zip":201,"country":125,"countryCode":126,"cosmosGeoPoint":202,"geoPoint":206,"contacts":70},"Stanford Medicine Outpatient Center","Redwood City","94063",{"type":128,"coordinates":203},[204,205],-122.23635,37.48522,{"lat":205,"lon":204},{"facility":208,"status":121,"city":209,"state":210,"zip":211,"country":125,"countryCode":126,"cosmosGeoPoint":212,"geoPoint":216,"contacts":70},"Peak Gastroenterology Associates","Colorado Springs","Colorado","80907",{"type":128,"coordinates":213},[214,215],-104.82136,38.83388,{"lat":215,"lon":214},{"facility":218,"status":121,"city":219,"state":220,"zip":221,"country":125,"countryCode":126,"cosmosGeoPoint":222,"geoPoint":226,"contacts":70},"Hi Tech and Global Research, LLC","Coral Gables","Florida","33134",{"type":128,"coordinates":223},[224,225],-80.26838,25.72149,{"lat":225,"lon":224},{"facility":228,"status":121,"city":229,"state":220,"zip":230,"country":125,"countryCode":126,"cosmosGeoPoint":231,"geoPoint":235,"contacts":70},"The Sister Life Research","Hialeah","33013",{"type":128,"coordinates":232},[233,234],-80.27811,25.8576,{"lat":234,"lon":233},{"facility":237,"status":121,"city":238,"state":220,"zip":239,"country":125,"countryCode":126,"cosmosGeoPoint":240,"geoPoint":244,"contacts":70},"LCC Medical Research Institute, LLC","Miami","33126",{"type":128,"coordinates":241},[242,243],-80.19366,25.77427,{"lat":243,"lon":242},{"facility":246,"status":121,"city":238,"state":220,"zip":247,"country":125,"countryCode":126,"cosmosGeoPoint":248,"geoPoint":250,"contacts":70},"Allied Biomedical Research Institute","33155",{"type":128,"coordinates":249},[242,243],{"lat":243,"lon":242},{"facility":252,"status":253,"city":238,"state":220,"zip":254,"country":125,"countryCode":126,"cosmosGeoPoint":255,"geoPoint":257,"contacts":70},"Ambert Medical Research","WITHDRAWN","33176",{"type":128,"coordinates":256},[242,243],{"lat":243,"lon":242},{"facility":259,"status":121,"city":260,"state":220,"zip":261,"country":125,"countryCode":126,"cosmosGeoPoint":262,"geoPoint":266,"contacts":70},"Integrity Trials LLC","Orlando","32807",{"type":128,"coordinates":263},[264,265],-81.37924,28.53834,{"lat":265,"lon":264},{"facility":268,"status":121,"city":260,"state":220,"zip":269,"country":125,"countryCode":126,"cosmosGeoPoint":270,"geoPoint":272,"contacts":70},"Digestive and Liver Center of Florida","32825",{"type":128,"coordinates":271},[264,265],{"lat":265,"lon":264},{"facility":274,"status":121,"city":275,"state":220,"zip":276,"country":125,"countryCode":126,"cosmosGeoPoint":277,"geoPoint":281,"contacts":70},"Advanced Medical Research Center","Port Orange","32127",{"type":128,"coordinates":278},[279,280],-80.99561,29.13832,{"lat":280,"lon":279},{"facility":283,"status":121,"city":284,"state":220,"zip":285,"country":125,"countryCode":126,"cosmosGeoPoint":286,"geoPoint":290,"contacts":70},"University of South Florida School of Medicine Morsani Center for Advanced Health Care","Tampa","33612",{"type":128,"coordinates":287},[288,289],-82.45843,27.94752,{"lat":289,"lon":288},{"facility":292,"status":121,"city":284,"state":220,"zip":293,"country":125,"countryCode":126,"cosmosGeoPoint":294,"geoPoint":296,"contacts":70},"Guardian Angel Research Center, LLC","33614",{"type":128,"coordinates":295},[288,289],{"lat":289,"lon":288},{"facility":298,"status":121,"city":284,"state":220,"zip":299,"country":125,"countryCode":126,"cosmosGeoPoint":300,"geoPoint":302,"contacts":70},"Santos Research Center, CORP","33615",{"type":128,"coordinates":301},[288,289],{"lat":289,"lon":288},{"facility":304,"status":121,"city":305,"state":220,"zip":306,"country":125,"countryCode":126,"cosmosGeoPoint":307,"geoPoint":311,"contacts":70},"Cleveland Clinic Florida","Weston","33331",{"type":128,"coordinates":308},[309,310],-80.39977,26.10037,{"lat":310,"lon":309},{"facility":313,"status":121,"city":314,"state":315,"zip":316,"country":125,"countryCode":126,"cosmosGeoPoint":317,"geoPoint":321,"contacts":70},"Randomize Now, LLC","Atlanta","Georgia","30308",{"type":128,"coordinates":318},[319,320],-84.38798,33.749,{"lat":320,"lon":319},{"facility":323,"status":121,"city":314,"state":315,"zip":324,"country":125,"countryCode":126,"cosmosGeoPoint":325,"geoPoint":327,"contacts":70},"Atlanta Gastroenterology Associates","30342",{"type":128,"coordinates":326},[319,320],{"lat":320,"lon":319},{"facility":329,"status":121,"city":330,"state":315,"zip":331,"country":125,"countryCode":126,"cosmosGeoPoint":332,"geoPoint":336,"contacts":70},"Gastroenterology Associates of Central Georgia","Macon","31201",{"type":128,"coordinates":333},[334,335],-83.6324,32.84069,{"lat":335,"lon":334},{"facility":338,"status":121,"city":339,"state":340,"zip":341,"country":125,"countryCode":126,"cosmosGeoPoint":342,"geoPoint":346,"contacts":70},"Grand Teton Research Group, PLLC","Idaho Falls","Idaho","83404",{"type":128,"coordinates":343},[344,345],-112.03414,43.46658,{"lat":345,"lon":344},{"facility":348,"status":121,"city":349,"state":350,"zip":351,"country":125,"countryCode":126,"cosmosGeoPoint":352,"geoPoint":356,"contacts":70},"Illinois Gastroenterology Group-Glenview powered by GI Alliance","Glenview","Illinois","60026",{"type":128,"coordinates":353},[354,355],-87.78784,42.06975,{"lat":355,"lon":354},{"facility":358,"status":121,"city":359,"state":350,"zip":360,"country":125,"countryCode":126,"cosmosGeoPoint":361,"geoPoint":365,"contacts":70},"GI Alliance - Gurnee","Gurnee","60031",{"type":128,"coordinates":362},[363,364],-87.90202,42.3703,{"lat":364,"lon":363},{"facility":367,"status":121,"city":368,"state":369,"zip":370,"country":125,"countryCode":126,"cosmosGeoPoint":371,"geoPoint":375,"contacts":70},"Gastro Health Partners, LLC","New Albany","Indiana","47150",{"type":128,"coordinates":372},[373,374],-85.82413,38.28562,{"lat":374,"lon":373},{"facility":377,"status":121,"city":378,"state":379,"zip":380,"country":125,"countryCode":126,"cosmosGeoPoint":381,"geoPoint":385,"contacts":70},"Kansas Gastroenterology, LLC under Clinical Trials Network","Wichita","Kansas","67226",{"type":128,"coordinates":382},[383,384],-97.33754,37.69224,{"lat":384,"lon":383},{"facility":387,"status":121,"city":388,"state":389,"zip":390,"country":125,"countryCode":126,"cosmosGeoPoint":391,"geoPoint":395,"contacts":70},"One GI: GHP - Gastroenterology Health Partners Louisville","Louisville","Kentucky","40218",{"type":128,"coordinates":392},[393,394],-85.75941,38.25424,{"lat":394,"lon":393},{"facility":397,"status":121,"city":398,"state":399,"zip":400,"country":125,"countryCode":126,"cosmosGeoPoint":401,"geoPoint":405,"contacts":70},"Louisiana Research Center - GastroIntestinal Associates","Shreveport","Louisiana","71105",{"type":128,"coordinates":402},[403,404],-93.75018,32.52515,{"lat":404,"lon":403},{"facility":407,"status":121,"city":408,"state":409,"zip":410,"country":125,"countryCode":126,"cosmosGeoPoint":411,"geoPoint":415,"contacts":70},"Allied Gastrointestinal Associates, PA","Flowood","Mississippi","39232",{"type":128,"coordinates":412},[413,414],-90.13898,32.30959,{"lat":414,"lon":413},{"facility":417,"status":121,"city":418,"state":409,"zip":419,"country":125,"countryCode":126,"cosmosGeoPoint":420,"geoPoint":424,"contacts":70},"Delta Gastroenterology & Endoscopy Center","Southaven","38671",{"type":128,"coordinates":421},[422,423],-90.01259,34.98898,{"lat":423,"lon":422},{"facility":426,"status":121,"city":427,"state":428,"zip":429,"country":125,"countryCode":126,"cosmosGeoPoint":430,"geoPoint":434,"contacts":70},"Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center","Lebanon","New Hampshire","03756",{"type":128,"coordinates":431},[432,433],-72.25176,43.64229,{"lat":433,"lon":432},{"facility":436,"status":121,"city":437,"state":438,"zip":439,"country":125,"countryCode":126,"cosmosGeoPoint":440,"geoPoint":444,"contacts":70},"Ellipsis Research Group","Brooklyn","New York","11215",{"type":128,"coordinates":441},[442,443],-73.94958,40.6501,{"lat":443,"lon":442},{"facility":446,"status":121,"city":438,"state":438,"zip":447,"country":125,"countryCode":126,"cosmosGeoPoint":448,"geoPoint":452,"contacts":70},"NYU Inflammatory Bowel Disease Center","10016",{"type":128,"coordinates":449},[450,451],-74.00597,40.71427,{"lat":451,"lon":450},{"facility":454,"status":121,"city":438,"state":438,"zip":455,"country":125,"countryCode":126,"cosmosGeoPoint":456,"geoPoint":458,"contacts":70},"Weill Cornell Medical College","10021",{"type":128,"coordinates":457},[450,451],{"lat":451,"lon":450},{"facility":460,"status":121,"city":461,"state":438,"zip":462,"country":125,"countryCode":126,"cosmosGeoPoint":463,"geoPoint":467,"contacts":70},"DiGiovanna Inst for Med Ed&Res","North Massapequa","11758",{"type":128,"coordinates":464},[465,466],-73.46207,40.70093,{"lat":466,"lon":465},{"facility":469,"status":121,"city":470,"state":438,"zip":471,"country":125,"countryCode":126,"cosmosGeoPoint":472,"geoPoint":476,"contacts":70},"Queens Village Medical Care","Queens Village","11428",{"type":128,"coordinates":473},[474,475],-73.74152,40.72677,{"lat":475,"lon":474},{"facility":478,"status":121,"city":479,"state":438,"zip":480,"country":125,"countryCode":126,"cosmosGeoPoint":481,"geoPoint":485,"contacts":70},"Gastroenterology Group Of Rochester, LLP","Rochester","14618",{"type":128,"coordinates":482},[483,484],-77.61556,43.15478,{"lat":484,"lon":483},{"facility":487,"status":121,"city":488,"state":438,"zip":489,"country":125,"countryCode":126,"cosmosGeoPoint":490,"geoPoint":494,"contacts":70},"James J Peters Veterans Administration Medical Center - NAVREF","The Bronx","10468",{"type":128,"coordinates":491},[492,493],-73.86641,40.84985,{"lat":493,"lon":492},{"facility":496,"status":121,"city":497,"state":498,"zip":499,"country":125,"countryCode":126,"cosmosGeoPoint":500,"geoPoint":504,"contacts":70},"Charlotte Gastroenterology and Hepatology, P.L.L.C","Charlotte","North 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9GZ",{"type":128,"coordinates":1871},[1872,1873],-0.24777,52.57364,{"lat":1873,"lon":1872},{"facility":1876,"status":121,"city":1877,"state":70,"zip":1878,"country":1842,"countryCode":1843,"cosmosGeoPoint":1879,"geoPoint":1883,"contacts":70},"Stepping Hill Hospital","Stockport","SK2 7JE",{"type":128,"coordinates":1880},[1881,1882],-2.15761,53.40979,{"lat":1882,"lon":1881},{"facility":1885,"status":121,"city":1886,"state":70,"zip":1887,"country":1842,"countryCode":1843,"cosmosGeoPoint":1888,"geoPoint":1892,"contacts":70},"New Cross Hospital","Wolverhampton","WV10 0QP",{"type":128,"coordinates":1889},[1890,1891],-2.12296,52.58547,{"lat":1891,"lon":1890},{"type":1894,"investigatorFullName":70,"investigatorTitle":70,"investigatorAffiliation":70,"oldNameTitle":70,"oldOrganization":70},"SPONSOR","100561337",false,"NCT06588855","A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis","Ametrine-2","Inclusion Criteria:\n\n* Confirmed diagnosis of UC\n* Moderately to severely active UC assessed by mMS\n* Bodyweight \\>= 40 kilogram (kg)\n* Up to date with colorectal cancer (CRC) screening performed according to local standards\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced UC therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)\n* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed\n* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy","ALL","16 Years","80 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