[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053737":3},{"organization":4,"armGroups":7,"interventions":98,"overallOfficials":115,"centralContacts":119,"locations":125,"responsibleParty":422,"collaborators":114,"id":424,"slug":425,"hasResults":426,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":114,"eligibilityCriteria":430,"healthyVolunteers":426,"sex":431,"minAge":432,"maxAge":433,"enrollmentInfo":434,"targetDuration":114,"studyType":437,"phases":438,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":449,"whyStopped":114,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":459},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14,18,23,27,31,35,39,43,47,51,54,57,62,66,70,74,78,82,86,90,94],{"label":9,"type":10,"description":11,"interventionNames":12},"Substudy 1: UC Arm 1 Risankizumab monotherapy","EXPERIMENTAL","Ulcerative Colitis (UC) participants will receive Risankizumab Dose A as induction treatment followed by Risankizumab Dose C as maintenance treatment.",[13],"Drug: Risankizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"Substudy 1: CD Arm 1 Risankizumab monotherapy","Crohn's Disease (CD) participants will receive Risankizumab Dose B as induction treatment followed by Risankizumab Dose D as maintenance treatment.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Substudy 1: UC Arm 2 Trosunilimab monotherapy","Ulcerative Colitis (UC) participants will receive Trosunilimab Dose A as induction treatment followed by Trosunilimab Dose C as maintenance treatment.",[22],"Drug: Trosunilimab",{"label":24,"type":10,"description":25,"interventionNames":26},"Substudy 1: CD Arm 2 Trosunilimab monotherapy","Crohn's Disease (CD) participants will receive Trosunilimab Dose B as induction treatment followed by Trosunilimab Dose D as maintenance treatment.",[22],{"label":28,"type":10,"description":29,"interventionNames":30},"Substudy 1: UC Arm 3 Trosunilimab monotherapy","Ulcerative Colitis (UC) participants will receive Trosunilimab Dose E as induction treatment followed by Trosunilimab Dose G as maintenance treatment.",[22],{"label":32,"type":10,"description":33,"interventionNames":34},"Substudy 1: CD Arm 3 Trosunilimab monotherapy","Crohn's Disease (CD) participants will receive Trosunilimab Dose F as induction treatment followed by Trosunilimab Dose H as maintenance treatment.",[22],{"label":36,"type":10,"description":37,"interventionNames":38},"Substudy 1: UC Arm 4 ABBV-466 (Risankizumab\u002FTrosunilimab)","Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab\u002FTrosunilimab) combo Dose A followed by a combination maintenance (Risankizumab\u002FTrosunilimab) combo Dose C",[13,22],{"label":40,"type":10,"description":41,"interventionNames":42},"Substudy 1: CD Arm 4 ABBV-466 (Risankizumab\u002FTrosunilimab)","Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab\u002FTrosunilimab) combo Dose B followed by a combination maintenance (Risankizumab\u002FTrosunilimab) combo Dose D",[13,22],{"label":44,"type":10,"description":45,"interventionNames":46},"Substudy 1: UC Arm 5 ABBV-466 (Risankizumab\u002FTrosunilimab)","Ulcerative Colitis (UC) participants will receive a combination induction treatment of ABBV-466 (Risankizumab\u002FTrosunilimab) combo Dose E followed by a combination maintenance (Risankizumab\u002FTrosunilimab) combo Dose G",[13,22],{"label":48,"type":10,"description":49,"interventionNames":50},"Substudy 1: CD Arm 5 ABBV-466 (Risankizumab\u002FTrosunilimab)","Crohn's Disease (CD) participants will receive a combination induction treatment of ABBV-466 (Risankizumab\u002FTrosunilimab) combo Dose F followed by a combination maintenance (Risankizumab\u002FTrosunilimab) combo Dose H",[13,22],{"label":52,"type":10,"description":11,"interventionNames":53},"Substudy 2: UC Arm 1 Risankizumab monotherapy",[13],{"label":55,"type":10,"description":16,"interventionNames":56},"Substudy 2: CD Arm 1 Risankizumab monotherapy",[13],{"label":58,"type":10,"description":59,"interventionNames":60},"Substudy 2: UC Arm 2 ABBV-701 monotherapy","Ulcerative Colitis (UC) participants will receive ABBV-701 Dose A as induction treatment and Dose C maintenance treatment.",[61],"Drug: ABBV-701",{"label":63,"type":10,"description":64,"interventionNames":65},"Substudy 2: CD Arm 2 ABBV-701 monotherapy","Crohn's Disease (CD) participants will receive ABBV-701 Dose B as induction treatment and Dose D maintenance treatment.",[61],{"label":67,"type":10,"description":68,"interventionNames":69},"Substudy 2: UC Arm 3 ABBV-701 monotherapy","Ulcerative Colitis (UC) participants will receive ABBV-701 Dose E as induction treatment and Dose G maintenance treatment.",[61],{"label":71,"type":10,"description":72,"interventionNames":73},"Substudy 2: CD Arm 3 ABBV-701 monotherapy","Crohn's Disease (CD) participants will receive ABBV-701 Dose F as induction treatment and Dose H maintenance treatment.",[61],{"label":75,"type":10,"description":76,"interventionNames":77},"Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab\u002FABBV-701)","Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose A followed by maintenance treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose C.",[13,61],{"label":79,"type":10,"description":80,"interventionNames":81},"Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab\u002FABBV-701)","Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose B followed by maintenance treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose D.",[13,61],{"label":83,"type":10,"description":84,"interventionNames":85},"Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab\u002FABBV-701)","Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose E followed by maintenance treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose G.",[13,61],{"label":87,"type":10,"description":88,"interventionNames":89},"Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab\u002FABBV-701)","Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose F followed by maintenance treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose H.",[13,61],{"label":91,"type":10,"description":92,"interventionNames":93},"Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab\u002FABBV-701)","Ulcerative Colitis (UC) participants will receive induction treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose I followed by maintenance treatment of ABBV-7066 (Risankizumab\u002FABBV-701) combination Dose J",[13,61],{"label":95,"type":10,"description":96,"interventionNames":97},"Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab\u002FABBV-701)","Crohn's Disease (CD) participants will receive induction treatment of ABBV-7066 (Risankizumab\u002F ABBV-701) combination Dose K followed by maintenance treatment of ABBV-7066 (Risankizumab\u002F ABBV-701) combination Dose L",[13,61],[99,106,111],{"type":100,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"DRUG","Risankizumab","Intravenous\u002FSubcutaneous\u002FIntramuscular Injection\u002FInfusion",[15,40,48,9,36,44,55,79,87,95,52,75,83,91],[105],"ABBV-066",{"type":100,"name":107,"description":102,"armGroupLabels":108,"otherNames":109},"Trosunilimab",[24,32,40,48,19,28,36,44],[110],"ABBV-382",{"type":100,"name":112,"description":102,"armGroupLabels":113,"otherNames":114},"ABBV-701",[63,71,79,87,95,58,67,75,83,91],null,[116],{"name":117,"affiliation":5,"role":118},"ABBVIE INC.","STUDY_DIRECTOR",[120],{"name":121,"role":122,"phone":123,"phoneExt":114,"email":124},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[126,139,148,158,168,177,187,197,207,216,223,232,242,251,261,273,283,293,303,312,324,331,341,352,364,370,380,392,401,410],{"facility":127,"status":114,"city":128,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":114},"Auzmer Research \u002FID# 280786","Lakeland","Florida","33813","United States","US",{"type":134,"coordinates":135},"Point",[136,137],-81.9498,28.03947,{"lat":137,"lon":136},{"facility":140,"status":114,"city":141,"state":129,"zip":142,"country":131,"countryCode":132,"cosmosGeoPoint":143,"geoPoint":147,"contacts":114},"Gastro Health - Miami \u002FID# 282001","Miami","33176",{"type":134,"coordinates":144},[145,146],-80.19366,25.77427,{"lat":146,"lon":145},{"facility":149,"status":114,"city":150,"state":151,"zip":152,"country":131,"countryCode":132,"cosmosGeoPoint":153,"geoPoint":157,"contacts":114},"Portland Gastroenterology Center - Portland - Congress Street \u002FID# 281970","Portland","Maine","04102",{"type":134,"coordinates":154},[155,156],-70.2589,43.65737,{"lat":156,"lon":155},{"facility":159,"status":114,"city":160,"state":161,"zip":162,"country":131,"countryCode":132,"cosmosGeoPoint":163,"geoPoint":167,"contacts":114},"Hackensack Meridian Health - Hackensack University Medical Center \u002FID# 281865","Hackensack","New Jersey","07601",{"type":134,"coordinates":164},[165,166],-74.04347,40.88593,{"lat":166,"lon":165},{"facility":169,"status":114,"city":170,"state":170,"zip":171,"country":131,"countryCode":132,"cosmosGeoPoint":172,"geoPoint":176,"contacts":114},"Queens Village Primary Medical Center \u002FID# 281857","New York","11428",{"type":134,"coordinates":173},[174,175],-74.00597,40.71427,{"lat":175,"lon":174},{"facility":178,"status":114,"city":179,"state":180,"zip":181,"country":131,"countryCode":132,"cosmosGeoPoint":182,"geoPoint":186,"contacts":114},"Digestive Disease Consultants - Brunswick \u002FID# 283935","Brunswick","Ohio","44212",{"type":134,"coordinates":183},[184,185],-81.8418,41.23811,{"lat":185,"lon":184},{"facility":188,"status":114,"city":189,"state":190,"zip":191,"country":131,"countryCode":132,"cosmosGeoPoint":192,"geoPoint":196,"contacts":114},"Skyline Gastroenterology of West Tennessee \u002FID# 284146","Jackson","Tennessee","38301",{"type":134,"coordinates":193},[194,195],-88.81395,35.61452,{"lat":195,"lon":194},{"facility":198,"status":114,"city":199,"state":200,"zip":201,"country":131,"countryCode":132,"cosmosGeoPoint":202,"geoPoint":206,"contacts":114},"Texas Digestive Disease Consultants \u002FID# 284159","Austin","Texas","78731",{"type":134,"coordinates":203},[204,205],-97.74306,30.26715,{"lat":205,"lon":204},{"facility":208,"status":114,"city":209,"state":200,"zip":210,"country":131,"countryCode":132,"cosmosGeoPoint":211,"geoPoint":215,"contacts":114},"Gi Alliance - Texas Digestive Disease Consultants - San Marcos \u002FID# 283947","San Marcos","78666",{"type":134,"coordinates":212},[213,214],-97.94139,29.88327,{"lat":214,"lon":213},{"facility":217,"status":114,"city":218,"state":219,"zip":220,"country":221,"countryCode":222,"cosmosGeoPoint":114,"geoPoint":114,"contacts":114},"Macquarie Hospital \u002FID# 281739","Macquarie University","New South Wales","02109","Australia","AU",{"facility":224,"status":114,"city":225,"state":219,"zip":226,"country":221,"countryCode":222,"cosmosGeoPoint":227,"geoPoint":231,"contacts":114},"John Hunter Hospital \u002FID# 282537","Newcastle","2305",{"type":134,"coordinates":228},[229,230],151.7801,-32.92953,{"lat":230,"lon":229},{"facility":233,"status":114,"city":234,"state":235,"zip":236,"country":221,"countryCode":222,"cosmosGeoPoint":237,"geoPoint":241,"contacts":114},"Mater Hospital Brisbane \u002FID# 281738","South Brisbane","Queensland","4101",{"type":134,"coordinates":238},[239,240],153.02049,-27.48034,{"lat":240,"lon":239},{"facility":243,"status":114,"city":244,"state":235,"zip":245,"country":221,"countryCode":222,"cosmosGeoPoint":246,"geoPoint":250,"contacts":114},"Gold Coast Hospital \u002FID# 282434","Southport","4215",{"type":134,"coordinates":247},[248,249],153.39796,-27.96724,{"lat":249,"lon":248},{"facility":252,"status":114,"city":253,"state":254,"zip":255,"country":221,"countryCode":222,"cosmosGeoPoint":256,"geoPoint":260,"contacts":114},"Monash Health - Monash Medical Centre - Clayton \u002FID# 281711","Clayton","Victoria","3168",{"type":134,"coordinates":257},[258,259],145.11667,-37.91667,{"lat":259,"lon":258},{"facility":262,"status":114,"city":263,"state":264,"zip":265,"country":266,"countryCode":267,"cosmosGeoPoint":268,"geoPoint":272,"contacts":114},"Universitair Ziekenhuis Antwerpen \u002FID# 282218","Edegem","Antwerpen","2650","Belgium","BE",{"type":134,"coordinates":269},[270,271],4.44504,51.15662,{"lat":271,"lon":270},{"facility":274,"status":114,"city":275,"state":276,"zip":277,"country":266,"countryCode":267,"cosmosGeoPoint":278,"geoPoint":282,"contacts":114},"Chu De Charleroi - Hopital Civil Marie Curie \u002FID# 281632","Lodelinsart","Hainaut","6042",{"type":134,"coordinates":279},[280,281],4.44886,50.43138,{"lat":281,"lon":280},{"facility":284,"status":114,"city":285,"state":286,"zip":287,"country":266,"countryCode":267,"cosmosGeoPoint":288,"geoPoint":292,"contacts":114},"Universite Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant \u002FID# 281312","Yvoir","Namur","5530",{"type":134,"coordinates":289},[290,291],4.88059,50.3279,{"lat":291,"lon":290},{"facility":294,"status":114,"city":295,"state":296,"zip":297,"country":266,"countryCode":267,"cosmosGeoPoint":298,"geoPoint":302,"contacts":114},"AZ-Delta. \u002FID# 281031","Roeselare","West-Vlaanderen","8800",{"type":134,"coordinates":299},[300,301],3.12269,50.94653,{"lat":301,"lon":300},{"facility":304,"status":114,"city":305,"state":114,"zip":306,"country":266,"countryCode":267,"cosmosGeoPoint":307,"geoPoint":311,"contacts":114},"CHU de Liege \u002FID# 281182","Liège","4000",{"type":134,"coordinates":308},[309,310],5.56749,50.63373,{"lat":310,"lon":309},{"facility":313,"status":114,"city":314,"state":315,"zip":316,"country":317,"countryCode":318,"cosmosGeoPoint":319,"geoPoint":323,"contacts":114},"Universitaetsklinikum Tuebingen \u002FID# 282958","Tübingen","Baden-Wurttemberg","72076","Germany","DE",{"type":134,"coordinates":320},[321,322],9.05222,48.52266,{"lat":322,"lon":321},{"facility":325,"status":114,"city":326,"state":327,"zip":328,"country":329,"countryCode":330,"cosmosGeoPoint":114,"geoPoint":114,"contacts":114},"Iwate Medical University Hospital \u002FID# 282387","Shiwa-gun","Iwate","028-3695","Japan","JP",{"facility":332,"status":114,"city":333,"state":334,"zip":335,"country":329,"countryCode":330,"cosmosGeoPoint":336,"geoPoint":340,"contacts":114},"Takagi Clinic - Sendai \u002FID# 281805","Sendai","Miyagi","981-3213",{"type":134,"coordinates":337},[338,339],140.86667,38.26667,{"lat":339,"lon":338},{"facility":342,"status":114,"city":343,"state":114,"zip":344,"country":345,"countryCode":346,"cosmosGeoPoint":347,"geoPoint":351,"contacts":114},"University Medical Centre Maribor \u002FID# 281175","Maribor","2000","Slovenia","SI",{"type":134,"coordinates":348},[349,350],15.64593,46.55583,{"lat":350,"lon":349},{"facility":353,"status":114,"city":354,"state":355,"zip":356,"country":357,"countryCode":358,"cosmosGeoPoint":359,"geoPoint":363,"contacts":114},"Lenasia Clinical Trial Centre - Johannesburg \u002FID# 281415","Johannesburg","Gauteng","1821","South Africa","ZA",{"type":134,"coordinates":360},[361,362],28.04363,-26.20227,{"lat":362,"lon":361},{"facility":365,"status":114,"city":354,"state":355,"zip":366,"country":357,"countryCode":358,"cosmosGeoPoint":367,"geoPoint":369,"contacts":114},"Chris Hani Baragwanath Hospital \u002FID# 284122","1864",{"type":134,"coordinates":368},[361,362],{"lat":362,"lon":361},{"facility":371,"status":114,"city":372,"state":373,"zip":374,"country":357,"countryCode":358,"cosmosGeoPoint":375,"geoPoint":379,"contacts":114},"Excellentis Clinical Trial Consultants \u002FID# 282430","George","Western Cape","6529",{"type":134,"coordinates":376},[377,378],22.46173,-33.963,{"lat":378,"lon":377},{"facility":381,"status":114,"city":382,"state":383,"zip":384,"country":385,"countryCode":386,"cosmosGeoPoint":387,"geoPoint":391,"contacts":114},"Hospital Galdakao-Usansolo \u002FID# 280388","Galdakao","Vizcaya","48960","Spain","ES",{"type":134,"coordinates":388},[389,390],-2.8429,43.23073,{"lat":390,"lon":389},{"facility":393,"status":114,"city":394,"state":114,"zip":395,"country":385,"countryCode":386,"cosmosGeoPoint":396,"geoPoint":400,"contacts":114},"Hospital Universitario Reina Sofia \u002FID# 281446","Córdoba","14004",{"type":134,"coordinates":397},[398,399],-4.77275,37.89155,{"lat":399,"lon":398},{"facility":402,"status":114,"city":403,"state":114,"zip":404,"country":385,"countryCode":386,"cosmosGeoPoint":405,"geoPoint":409,"contacts":114},"Hospital Rio Hortega \u002FID# 281426","Valladolid","47012",{"type":134,"coordinates":406},[407,408],-4.72353,41.65541,{"lat":408,"lon":407},{"facility":411,"status":114,"city":412,"state":413,"zip":414,"country":415,"countryCode":416,"cosmosGeoPoint":417,"geoPoint":421,"contacts":114},"University Hospital Zurich \u002FID# 280548","Zurich","Canton of Zurich","8091","Switzerland","CH",{"type":134,"coordinates":418},[419,420],8.55,47.36667,{"lat":420,"lon":419},{"type":423,"investigatorFullName":114,"investigatorTitle":114,"investigatorAffiliation":114,"oldNameTitle":114,"oldOrganization":114},"SPONSOR","100053737","phase-2-study-of-advanced-therapies-for-the-treatment-of-adult-participants-with-moderately-to-severely-active-crohns-disease-or-ulcerative-colitis-100053737",false,"NCT07697456","Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","Inclusion Criteria:\n\nCD specific:\n\n* Crohn's Disease Activity Index (CDAI) score of ≥ 220\n* Confirmed diagnosis of CD at least 90 days prior to Baseline\n* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.\n* Demonstrated failure of 1 or more therapy for CD\n\nUC specific:\n\n* Confirmed diagnosis of UC at least 90 days prior to Baseline\n* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3\n* Demonstrated failure of 1 or more therapy for UC\n\nExclusion Criteria:\n\n* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)\n* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment\n* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame\n* Participants with surgical bowel resection within the past 3 months prior to Baseline\n\nCD specific:\n\n* Participants with \\>3 prior bowel resections\n* Participants with previous small bowel resection(s) of combined length \\>100 cm\n\nUC specific:\n\n* Participants with prior colectomy (total or subtotal)\n* Participants with extent of disease limited to \\\u003C 10 cm of rectum","ALL","18 Years","75 Years",{"count":435,"type":436},2000,"ESTIMATED","INTERVENTIONAL",[439],"PHASE2","Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).\n\nThis study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[442,443],"Crohn's Disease","Ulcerative Colitis",[445,446,101,112,107,447,448],"Crohn's disease","Ulcerative colitis","ABBV-466","ABBV-7066","NOT_YET_RECRUITING","2026-07-07",{"date":452,"type":453},"2026-07-13","ACTUAL",{"date":455,"type":436},"2026-07-24",{"date":457,"type":436},"2031-10",{"name":5,"class":6},30]