[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579098":3},{"organization":4,"outcomesModule":7,"designInfo":99,"detailedDescription":98,"studyPopulation":98,"armGroups":108,"interventions":125,"overallOfficials":140,"centralContacts":144,"locations":152,"responsibleParty":3310,"collaborators":3312,"id":3315,"slug":3316,"hasResults":3317,"nctId":3318,"briefTitle":3319,"officialTitle":3320,"acronym":3321,"eligibilityCriteria":3322,"healthyVolunteers":3317,"sex":3323,"minAge":3324,"maxAge":3325,"enrollmentInfo":3326,"targetDuration":98,"studyType":3329,"phases":3330,"briefSummary":3332,"conditions":3333,"keywords":98,"overallStatus":155,"whyStopped":98,"lastUpdateSubmitDate":3335,"lastUpdatePostDateStruct":3336,"startDateStruct":3339,"completionDateStruct":3341,"leadSponsor":3343,"locationsCount":3344},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":98},[9,13],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI) Score","Percentage of participants achieving a CDAI score of \\\u003C150. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.","At Week 52",{"measure":14,"description":15,"timeFrame":12},"Percentage of Participants with Endoscopic Response","Percentage of participants achieving a decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) of \\>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.",[17,20,22,25,28,31,35,38,40,41,44,48,51,54,55,59,63,66,69,71,73,74,77,80,84,87,91,95],{"measure":18,"description":11,"timeFrame":19},"Percentage of Participants with Clinical Remission","At Week 12",{"measure":14,"description":21,"timeFrame":19},"Percentage of participants achieving a decrease in SES-CD of \\>50% from baseline. The SES-CD is a composite of four features of endoscopic activity (presence and size of ulcers, extent of ulcerated surface, extent of affected and presence and type of narrowings or stenosis) in up to five ileocolonic segments (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum). Each feature is scored on a scale from 0 to 3, giving segment subscores of 0 to 12 points and a total SES-CD range of 0-60, with a higher value indicating greater severity.",{"measure":23,"description":24,"timeFrame":19},"Percentage of Participants with Symptomatic Remission","Percentage of participants with the daily number of liquid or very soft stools \\\u003C=2.8 and the average of daily abdominal pain scores in the past week \\\u003C=1, with neither being greater than baseline.",{"measure":26,"description":27,"timeFrame":19},"Percentage of Participants with Endoscopic Remission","Percentage of participants with an SES-CD of 0 to 4 with a decrease from baseline \\>=2 and no subscore \\>1.",{"measure":29,"description":30,"timeFrame":19},"Percentage of Participants with Ulcer-free Endoscopy","Percentage of participants with an SES-CD ulcerated surface subscore of 0.",{"measure":32,"description":33,"timeFrame":34},"Average of Daily Number of Liquid or Very Soft Stools in the Past Week (SF)","Daily average number of liquid or very soft stools over 7 days.","Baseline through Week 12",{"measure":36,"description":37,"timeFrame":34},"Average of Daily Abdominal Pain Scores in the Past Week (APS)","The average daily rating of abdominal pain in the past 7 days. The pain is assessed on a scale of 0-3 with 0 indicating no pain and 3 indicating severe pain.",{"measure":26,"description":39,"timeFrame":12},"Percentage of participants with SES-CD=0 to 4 with decrease from baseline \\>=2 and no subscore \\>1 .",{"measure":23,"description":24,"timeFrame":12},{"measure":42,"description":43,"timeFrame":12},"Percentage of Participants with Corticosteroid-free Clinical Remission","Percentage of participants with clinical remission at Week 52 and no use of corticosteroids for CD at least 8 weeks prior to Week 52.",{"measure":45,"description":46,"timeFrame":47},"Maintenance of Clinical Remission","Percentage of participants with clinical remission at both Weeks 12 and 52.","At Weeks 12 and 52",{"measure":49,"description":50,"timeFrame":47},"Maintenance of Endoscopic Response","Percentage of participants with endoscopic response at both Weeks 12 and 52.",{"measure":52,"description":53,"timeFrame":12},"Percentage of Participants with Clinical Remission and Endoscopic Remission at Week 52","Percentage of participants achieving a CDAI score of \\\u003C150 and SES-CD of 0 to 4 with a decrease from baseline \\>=2 and no subscore \\>1 at Week 52.",{"measure":29,"description":30,"timeFrame":12},{"measure":56,"description":57,"timeFrame":58},"Bowel Urgency","Bowel urgency from baseline through week 12 and week 52. Bowel urgency is a single-item self-reported assessment of sudden or immediate need to have a bowel movement in the past 24 hours. The item response is reported on a 4-point Likert scale, from \"None\" to \"Severe.\"","Baseline through Week 12 and Week 52",{"measure":60,"description":61,"timeFrame":62},"Fatigue","Fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), from baseline to Week 12 and Week 52. FACIT-F is a 13-item self-reported assessment of fatigue. Each item response option indicates the degree to which a given statement describing the level or impact of fatigue applies in the past 7 days. Response options are graded on a 5-point Likert-type scale, from \"Not at all\" to \"Very much.\"","Baseline to Week 12 and Week 52",{"measure":64,"description":65,"timeFrame":62},"Inflammatory Bowel Disease Questionnaire (IBDQ) Score","Change in IBDQ score from baseline to week 12 and 52. The IBDQ is a 32-item questionnaire that measures four domains: bowel symptoms (10 questions); systemic symptoms (5 questions); emotional function (12 questions); and social function (5 questions). The total score ranges from 32-224, with a higher score indicating a better quality of life.",{"measure":67,"description":68,"timeFrame":19},"Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants","Percentage of participants achieving a CDAI score of \\\u003C150 at Week 12 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.",{"measure":67,"description":70,"timeFrame":12},"Percentage of participants achieving a CDAI score of \\\u003C150 at Week 52 in biomarker-defined subgroups. The index is a weighted sum of scores on eight components: number of liquid or soft stools (stool frequency), abdominal pain, general well-being, number of complications, use of anti-diarrheal medication, presence of an abdominal mass, hematocrit, and percentage deviation from standard body weight. CDAI generally ranges from 0 to roughly 600, with higher values indicating greater activity.",{"measure":72,"description":21,"timeFrame":19},"Percentage of Participants with Endoscopic Response: Among Biomarker-Defined Subgroups of Participants",{"measure":72,"description":21,"timeFrame":12},{"measure":75,"description":76,"timeFrame":19},"Percentage of Participants with Clinical Response","Percentage of participants with a decrease \\>=100 in CDAI from baseline.",{"measure":78,"description":79,"timeFrame":19},"Percentage of Participants with Symptomatic Response","Percentage of participants with a decrease \\>=30% in both SF and APS, with neither being greater than baseline.",{"measure":81,"description":82,"timeFrame":83},"Overall Change in CD Symptoms","Overall change in CD symptoms, as measured by the Patient Global Impression of Change (PGIC) from baseline to Weeks 2, 6, 12 and 52. PGIC measures overall change in Crohn's disease symptoms from \"Much better\" to \"Much worse\".","Baseline to Weeks 2, 6, 12 and 52",{"measure":85,"description":86,"timeFrame":83},"Overall Severity in CD Symptoms","Overall severity in CD symptoms, as measured by the Patient Global Impression of Severity (PGIS) from baseline to Weeks 2, 6, 12 and 52. PGIS measures severity of Crohn's disease symptoms from \"None\" to \"Very severe\".",{"measure":88,"description":89,"timeFrame":90},"Change in General Well-being","The average daily rating of general well-being in the past 7 days. Well-being is assessed on a scale of 0-4 with 0 indicating generally well and 4 indicating terrible.","Baseline through Week 52",{"measure":92,"description":93,"timeFrame":94},"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 70 Weeks after Baseline",{"measure":96,"description":97,"timeFrame":58},"Percentage of Participants with a Presence of Draining Fistulas","Fistulas will be assessed for draining or closed status, where closed fistulas will be assessed by the investigator as no longer draining.",null,{"allocation":100,"interventionModel":101,"interventionModelDescription":98,"primaryPurpose":102,"observationalModel":98,"timePerspective":98,"maskingInfo":103},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":104,"maskingDescription":98,"whoMasked":105},"DOUBLE",[106,107],"PARTICIPANT","INVESTIGATOR",[109,115,119],{"label":110,"type":111,"description":112,"interventionNames":113},"Arm 1: Afimkibart","EXPERIMENTAL","Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection.",[114],"Drug: Afimkibart",{"label":116,"type":111,"description":117,"interventionNames":118},"Arm 2: Afimkibart","Participants will receive afimkibart IV followed by afimkibart SC injection.",[114],{"label":120,"type":121,"description":122,"interventionNames":123},"Arm 3: Placebo","PLACEBO_COMPARATOR","Participants will receive placebo IV followed by placebo SC.",[124],"Drug: Placebo",[126,136],{"type":127,"name":128,"description":129,"armGroupLabels":130,"otherNames":131},"DRUG","Afimkibart","Afimkibart will be administered as IV infusion. Afimkibart will be administered as SC injection.",[110,116],[132,133,134,135],"PF-06480605","RVT-3101","RG6631","RO7790121",{"type":127,"name":137,"description":138,"armGroupLabels":139,"otherNames":98},"Placebo","Placebo matching IV afimkibart. Placebo matching SC afimkibart.",[120],[141],{"name":142,"affiliation":5,"role":143},"Clinical Trials","STUDY_DIRECTOR",[145,150],{"name":146,"role":147,"phone":148,"phoneExt":98,"email":149},"Reference Study ID Number: GA45331 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":151,"role":147,"phone":98,"phoneExt":98,"email":98},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[153,167,177,186,195,205,214,223,232,237,246,255,264,269,279,288,298,307,316,321,330,336,345,354,363,370,379,388,394,400,409,418,427,437,443,452,462,472,481,490,500,509,519,529,537,547,553,563,573,582,592,601,607,616,625,634,643,649,659,668,677,687,696,705,714,723,729,738,747,757,767,776,786,796,805,815,824,834,843,852,861,870,879,888,897,906,915,924,934,943,952,961,970,980,989,995,1004,1016,1026,1036,1045,1054,1064,1070,1080,1090,1099,1110,1119,1128,1134,1145,1154,1163,1172,1177,1186,1195,1200,1209,1218,1230,1240,1250,1260,1270,1279,1287,1293,1304,1313,1321,1326,1335,1347,1357,1367,1378,1387,1392,1403,1412,1421,1430,1439,1448,1457,1463,1472,1478,1487,1493,1502,1511,1520,1529,1538,1547,1556,1565,1571,1580,1589,1597,1606,1617,1624,1633,1642,1653,1662,1672,1681,1690,1696,1707,1718,1729,1738,1747,1756,1765,1774,1783,1794,1803,1809,1818,1827,1836,1845,1854,1865,1871,1882,1891,1897,1903,1912,1921,1930,1942,1952,1961,1967,1977,1987,1997,2007,2013,2018,2027,2032,2042,2054,2063,2072,2081,2093,2103,2113,2123,2129,2139,2145,2149,2158,2167,2176,2180,2190,2200,2210,2220,2227,2237,2247,2256,2262,2271,2274,2283,2292,2296,2305,2314,2320,2326,2332,2338,2347,2353,2356,2359,2362,2371,2380,2389,2398,2407,2413,2422,2430,2436,2445,2454,2463,2469,2478,2484,2493,2499,2505,2514,2520,2526,2532,2538,2544,2550,2559,2568,2577,2586,2598,2602,2612,2623,2627,2636,2645,2656,2662,2668,2672,2676,2685,2694,2702,2711,2717,2726,2735,2744,2753,2762,2771,2780,2784,2793,2799,2803,2806,2809,2818,2827,2838,2847,2856,2865,2874,2885,2891,2902,2908,2919,2925,2930,2936,2945,2954,2965,2971,2980,2989,2999,3005,3014,3023,3027,3036,3045,3051,3057,3063,3069,3075,3087,3092,3101,3110,3119,3128,3140,3149,3158,3164,3175,3181,3190,3199,3208,3218,3224,3230,3239,3250,3259,3268,3277,3283,3292,3301],{"facility":154,"status":155,"city":156,"state":157,"zip":158,"country":159,"countryCode":160,"cosmosGeoPoint":161,"geoPoint":166,"contacts":98},"Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan","RECRUITING","Dothan","Alabama","36305","United States","US",{"type":162,"coordinates":163},"Point",[164,165],-85.39049,31.22323,{"lat":165,"lon":164},{"facility":168,"status":155,"city":169,"state":170,"zip":171,"country":159,"countryCode":160,"cosmosGeoPoint":172,"geoPoint":176,"contacts":98},"Mayo Clinic Hospital","Phoenix","Arizona","85054",{"type":162,"coordinates":173},[174,175],-112.07404,33.44838,{"lat":175,"lon":174},{"facility":178,"status":155,"city":179,"state":170,"zip":180,"country":159,"countryCode":160,"cosmosGeoPoint":181,"geoPoint":185,"contacts":98},"Arizona Digestive Health, P.C (ADH)","Sun City","85351",{"type":162,"coordinates":182},[183,184],-112.27182,33.59754,{"lat":184,"lon":183},{"facility":187,"status":155,"city":188,"state":170,"zip":189,"country":159,"countryCode":160,"cosmosGeoPoint":190,"geoPoint":194,"contacts":98},"University of Arizona-CATS Research Center","Tucson","85724",{"type":162,"coordinates":191},[192,193],-110.92648,32.22174,{"lat":193,"lon":192},{"facility":196,"status":155,"city":197,"state":198,"zip":199,"country":159,"countryCode":160,"cosmosGeoPoint":200,"geoPoint":204,"contacts":98},"Valley View Internal Medicine","Garden Grove","California","92845-2006",{"type":162,"coordinates":201},[202,203],-117.94145,33.77391,{"lat":203,"lon":202},{"facility":206,"status":155,"city":207,"state":198,"zip":208,"country":159,"countryCode":160,"cosmosGeoPoint":209,"geoPoint":213,"contacts":98},"310 Clinical Research","Inglewood","90301",{"type":162,"coordinates":210},[211,212],-118.35313,33.96168,{"lat":212,"lon":211},{"facility":215,"status":155,"city":216,"state":198,"zip":217,"country":159,"countryCode":160,"cosmosGeoPoint":218,"geoPoint":222,"contacts":98},"UCSD Medical Center","La Jolla","92037-0897",{"type":162,"coordinates":219},[220,221],-117.2742,32.84727,{"lat":221,"lon":220},{"facility":224,"status":155,"city":225,"state":198,"zip":226,"country":159,"countryCode":160,"cosmosGeoPoint":227,"geoPoint":231,"contacts":98},"Gastro Care Associates","Lancaster","93534",{"type":162,"coordinates":228},[229,230],-118.13674,34.69804,{"lat":230,"lon":229},{"facility":233,"status":155,"city":225,"state":198,"zip":226,"country":159,"countryCode":160,"cosmosGeoPoint":234,"geoPoint":236,"contacts":98},"Om Research LLC",{"type":162,"coordinates":235},[229,230],{"lat":230,"lon":229},{"facility":238,"status":155,"city":239,"state":198,"zip":240,"country":159,"countryCode":160,"cosmosGeoPoint":241,"geoPoint":245,"contacts":98},"United Gastroenterologists","Los Alamitos","90720",{"type":162,"coordinates":242},[243,244],-118.07256,33.80307,{"lat":244,"lon":243},{"facility":247,"status":155,"city":248,"state":198,"zip":249,"country":159,"countryCode":160,"cosmosGeoPoint":250,"geoPoint":254,"contacts":98},"Acclaim Clinical Research, Inc.","San Diego","92120",{"type":162,"coordinates":251},[252,253],-117.16472,32.71571,{"lat":253,"lon":252},{"facility":256,"status":155,"city":257,"state":198,"zip":258,"country":159,"countryCode":160,"cosmosGeoPoint":259,"geoPoint":263,"contacts":98},"Kaiser Permanente","San Francisco","94115",{"type":162,"coordinates":260},[261,262],-122.41942,37.77493,{"lat":262,"lon":261},{"facility":265,"status":155,"city":257,"state":198,"zip":258,"country":159,"countryCode":160,"cosmosGeoPoint":266,"geoPoint":268,"contacts":98},"UCSF\u002FMedical Center at Mount Zion",{"type":162,"coordinates":267},[261,262],{"lat":262,"lon":261},{"facility":270,"status":155,"city":271,"state":272,"zip":273,"country":159,"countryCode":160,"cosmosGeoPoint":274,"geoPoint":278,"contacts":98},"Rocky Mountain Gastroenterology","Littleton","Colorado","80120",{"type":162,"coordinates":275},[276,277],-105.01665,39.61332,{"lat":277,"lon":276},{"facility":280,"status":155,"city":281,"state":272,"zip":282,"country":159,"countryCode":160,"cosmosGeoPoint":283,"geoPoint":287,"contacts":98},"Peak Gastroenterology Surgery Center","Lone Tree","80124",{"type":162,"coordinates":284},[285,286],-104.8863,39.55171,{"lat":286,"lon":285},{"facility":289,"status":155,"city":290,"state":291,"zip":292,"country":159,"countryCode":160,"cosmosGeoPoint":293,"geoPoint":297,"contacts":98},"Access Research Institute","Brooksville","Florida","34613",{"type":162,"coordinates":294},[295,296],-82.38991,28.55554,{"lat":296,"lon":295},{"facility":299,"status":155,"city":300,"state":291,"zip":301,"country":159,"countryCode":160,"cosmosGeoPoint":302,"geoPoint":306,"contacts":98},"Gastro Florida","Clearwater","33756",{"type":162,"coordinates":303},[304,305],-82.8001,27.96585,{"lat":305,"lon":304},{"facility":308,"status":155,"city":309,"state":291,"zip":310,"country":159,"countryCode":160,"cosmosGeoPoint":311,"geoPoint":315,"contacts":98},"HealthMed Clinical Center Inc.","Coral Gables","33134",{"type":162,"coordinates":312},[313,314],-80.26838,25.72149,{"lat":314,"lon":313},{"facility":317,"status":155,"city":309,"state":291,"zip":310,"country":159,"countryCode":160,"cosmosGeoPoint":318,"geoPoint":320,"contacts":98},"Hi Tech and Global Research, LLC",{"type":162,"coordinates":319},[313,314],{"lat":314,"lon":313},{"facility":322,"status":155,"city":323,"state":291,"zip":324,"country":159,"countryCode":160,"cosmosGeoPoint":325,"geoPoint":329,"contacts":98},"The Sister Life Research","Hialeah","33013",{"type":162,"coordinates":326},[327,328],-80.27811,25.8576,{"lat":328,"lon":327},{"facility":331,"status":155,"city":323,"state":291,"zip":332,"country":159,"countryCode":160,"cosmosGeoPoint":333,"geoPoint":335,"contacts":98},"NeoClinical Research","33016",{"type":162,"coordinates":334},[327,328],{"lat":328,"lon":327},{"facility":337,"status":155,"city":338,"state":291,"zip":339,"country":159,"countryCode":160,"cosmosGeoPoint":340,"geoPoint":344,"contacts":98},"Clinical Research of Osceola, LLC","Kissimmee","34741",{"type":162,"coordinates":341},[342,343],-81.41667,28.30468,{"lat":343,"lon":342},{"facility":346,"status":155,"city":347,"state":291,"zip":348,"country":159,"countryCode":160,"cosmosGeoPoint":349,"geoPoint":353,"contacts":98},"Florida Research Institute - Lakewood","Lakewood Rch","34211",{"type":162,"coordinates":350},[351,352],-82.4332,27.3863,{"lat":352,"lon":351},{"facility":355,"status":155,"city":356,"state":291,"zip":357,"country":159,"countryCode":160,"cosmosGeoPoint":358,"geoPoint":362,"contacts":98},"LCC Medical Research Institute, LLC","Miami","33126",{"type":162,"coordinates":359},[360,361],-80.19366,25.77427,{"lat":361,"lon":360},{"facility":364,"status":365,"city":356,"state":291,"zip":366,"country":159,"countryCode":160,"cosmosGeoPoint":367,"geoPoint":369,"contacts":98},"Ambert Medical Research","WITHDRAWN","33176",{"type":162,"coordinates":368},[360,361],{"lat":361,"lon":360},{"facility":371,"status":155,"city":372,"state":291,"zip":373,"country":159,"countryCode":160,"cosmosGeoPoint":374,"geoPoint":378,"contacts":98},"Orlando Regional Healthcare","Orlando","32806",{"type":162,"coordinates":375},[376,377],-81.37924,28.53834,{"lat":377,"lon":376},{"facility":380,"status":155,"city":381,"state":291,"zip":382,"country":159,"countryCode":160,"cosmosGeoPoint":383,"geoPoint":387,"contacts":98},"Nodal Medical Center Research - NMC","Tampa","33607",{"type":162,"coordinates":384},[385,386],-82.45843,27.94752,{"lat":386,"lon":385},{"facility":389,"status":155,"city":381,"state":291,"zip":390,"country":159,"countryCode":160,"cosmosGeoPoint":391,"geoPoint":393,"contacts":98},"University of South Florida School of Medicine Morsani Center for Advanced Health Care","33612",{"type":162,"coordinates":392},[385,386],{"lat":386,"lon":385},{"facility":395,"status":155,"city":381,"state":291,"zip":396,"country":159,"countryCode":160,"cosmosGeoPoint":397,"geoPoint":399,"contacts":98},"Guardian Angel Research Center, LLC","33614",{"type":162,"coordinates":398},[385,386],{"lat":386,"lon":385},{"facility":401,"status":155,"city":402,"state":291,"zip":403,"country":159,"countryCode":160,"cosmosGeoPoint":404,"geoPoint":408,"contacts":98},"Theia Clinical Research Centers, LLC","Temple Terrace","33617",{"type":162,"coordinates":405},[406,407],-82.38926,28.0353,{"lat":407,"lon":406},{"facility":410,"status":155,"city":411,"state":291,"zip":412,"country":159,"countryCode":160,"cosmosGeoPoint":413,"geoPoint":417,"contacts":98},"Cleveland Clinic Florida","Weston","33331",{"type":162,"coordinates":414},[415,416],-80.39977,26.10037,{"lat":416,"lon":415},{"facility":419,"status":155,"city":420,"state":291,"zip":421,"country":159,"countryCode":160,"cosmosGeoPoint":422,"geoPoint":426,"contacts":98},"Florida Medical Clinic - Orlando Health","Zephyrhills","33542",{"type":162,"coordinates":423},[424,425],-82.18119,28.23362,{"lat":425,"lon":424},{"facility":428,"status":155,"city":429,"state":430,"zip":431,"country":159,"countryCode":160,"cosmosGeoPoint":432,"geoPoint":436,"contacts":98},"Digestive Healthcare of Georgia","Atlanta","Georgia","30327",{"type":162,"coordinates":433},[434,435],-84.38798,33.749,{"lat":435,"lon":434},{"facility":438,"status":155,"city":429,"state":430,"zip":439,"country":159,"countryCode":160,"cosmosGeoPoint":440,"geoPoint":442,"contacts":98},"Atlanta Gastroenterology 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Kaen","40002",{"type":162,"coordinates":3186},[3187,3188],102.833,16.44671,{"lat":3188,"lon":3187},{"facility":3191,"status":155,"city":3192,"state":98,"zip":3193,"country":3168,"countryCode":3169,"cosmosGeoPoint":3194,"geoPoint":3198,"contacts":98},"Thammasat University Hospital","Pathum Thani","12120",{"type":162,"coordinates":3195},[3196,3197],100.53049,14.01346,{"lat":3197,"lon":3196},{"facility":3200,"status":155,"city":3201,"state":98,"zip":3202,"country":3168,"countryCode":3169,"cosmosGeoPoint":3203,"geoPoint":3207,"contacts":98},"Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University","Songkhla","90110",{"type":162,"coordinates":3204},[3205,3206],100.5951,7.19882,{"lat":3206,"lon":3205},{"facility":3209,"status":155,"city":3210,"state":98,"zip":1620,"country":3211,"countryCode":3212,"cosmosGeoPoint":3213,"geoPoint":3217,"contacts":98},"Sheikh Shakhbout Medical City","Abu Dhabi","United Arab Emirates","AE",{"type":162,"coordinates":3214},[3215,3216],54.39696,24.45118,{"lat":3216,"lon":3215},{"facility":3219,"status":155,"city":3210,"state":98,"zip":3220,"country":3211,"countryCode":3212,"cosmosGeoPoint":3221,"geoPoint":3223,"contacts":98},"Sheikh Khalifa Medical City (SKMC)","51900",{"type":162,"coordinates":3222},[3215,3216],{"lat":3216,"lon":3215},{"facility":3225,"status":155,"city":3210,"state":98,"zip":3226,"country":3211,"countryCode":3212,"cosmosGeoPoint":3227,"geoPoint":3229,"contacts":98},"Burjeel Hopital","7400",{"type":162,"coordinates":3228},[3215,3216],{"lat":3216,"lon":3215},{"facility":3231,"status":155,"city":3232,"state":98,"zip":3233,"country":3211,"countryCode":3212,"cosmosGeoPoint":3234,"geoPoint":3238,"contacts":98},"Rashid Hospital","Dubai","4545",{"type":162,"coordinates":3235},[3236,3237],55.30927,25.07725,{"lat":3237,"lon":3236},{"facility":3240,"status":155,"city":3241,"state":98,"zip":3242,"country":3243,"countryCode":3244,"cosmosGeoPoint":3245,"geoPoint":3249,"contacts":98},"Addenbrookes Hospital","Cambridge","CB2 0QQ","United Kingdom","UK",{"type":162,"coordinates":3246},[3247,3248],0.11667,52.2,{"lat":3248,"lon":3247},{"facility":3251,"status":155,"city":3252,"state":98,"zip":3253,"country":3243,"countryCode":3244,"cosmosGeoPoint":3254,"geoPoint":3258,"contacts":98},"St Mark's Hospital & Imperial College","Harrow","HA1 3UJ",{"type":162,"coordinates":3255},[3256,3257],-0.33208,51.57835,{"lat":3257,"lon":3256},{"facility":3260,"status":155,"city":3261,"state":98,"zip":3262,"country":3243,"countryCode":3244,"cosmosGeoPoint":3263,"geoPoint":3267,"contacts":98},"Royal Liverpool University Hospital","Liverpool","L7 8XP",{"type":162,"coordinates":3264},[3265,3266],-2.97794,53.41058,{"lat":3266,"lon":3265},{"facility":3269,"status":155,"city":3270,"state":98,"zip":3271,"country":3243,"countryCode":3244,"cosmosGeoPoint":3272,"geoPoint":3276,"contacts":98},"King College Hospital NHS Foundation Trust","London","SE5 9RS",{"type":162,"coordinates":3273},[3274,3275],-0.12574,51.50853,{"lat":3275,"lon":3274},{"facility":3278,"status":365,"city":3270,"state":98,"zip":3279,"country":3243,"countryCode":3244,"cosmosGeoPoint":3280,"geoPoint":3282,"contacts":98},"Queen Anne Street Medical Centre","W1T 6AH",{"type":162,"coordinates":3281},[3274,3275],{"lat":3275,"lon":3274},{"facility":3284,"status":155,"city":3285,"state":98,"zip":3286,"country":3243,"countryCode":3244,"cosmosGeoPoint":3287,"geoPoint":3291,"contacts":98},"Royal Victoria Infirmary","Newcastle upon Tyne","NE1 4LP",{"type":162,"coordinates":3288},[3289,3290],-1.61396,54.97328,{"lat":3290,"lon":3289},{"facility":3293,"status":155,"city":3294,"state":98,"zip":3295,"country":3243,"countryCode":3244,"cosmosGeoPoint":3296,"geoPoint":3300,"contacts":98},"North Tyneside General Hospital","North Shields","NE29 8NH",{"type":162,"coordinates":3297},[3298,3299],-1.44925,55.01646,{"lat":3299,"lon":3298},{"facility":3302,"status":155,"city":3303,"state":98,"zip":3304,"country":3243,"countryCode":3244,"cosmosGeoPoint":3305,"geoPoint":3309,"contacts":98},"Nottingham University Hospitals Queen's Medical Centre","Nottingham","NG7 2UH",{"type":162,"coordinates":3306},[3307,3308],-1.15047,52.9536,{"lat":3308,"lon":3307},{"type":3311,"investigatorFullName":98,"investigatorTitle":98,"investigatorAffiliation":98,"oldNameTitle":98,"oldOrganization":98},"SPONSOR",[3313],{"name":3314,"class":6},"Chugai Pharmaceutical","100579098","phase-3-a-study-to-assess-the-efficacy-and-safety-of-induction-and-maintenance-therapy-with-afimkibart-ro7790121-in-participants-with-moderately-to-severely-active-crohns-disease-100579098",false,"NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin 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) during screening\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 Years",{"count":3327,"type":3328},600,"ESTIMATED","INTERVENTIONAL",[3331],"PHASE3","This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[3334],"Moderately to Severely Active Crohns Disease","2026-08-18",{"date":3337,"type":3338},"2026-08-20","ACTUAL",{"date":3340,"type":3338},"2025-03-17",{"date":3342,"type":3328},"2033-12-31",{"name":5,"class":6},373]