[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07697456":3,"trial-entities:NCT07697456":412,"trial-summary:NCT07697456":416},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":71,"secondary_outcomes":83,"sex":113,"minimum_age":114,"maximum_age":115,"healthy_volunteers":15,"eligibility_criteria":116,"std_ages":135,"locations":138,"central_contacts":401,"overall_officials":406,"references":410,"see_also_links":411},"NCT07697456","M26-266","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","RECRUITING","2031-10","2026-09","2026-09-15","2026-07-31","AbbVie","INDUSTRY",false,"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.",null,[19,20],"Crohn's Disease","Ulcerative Colitis",[22,23,24,25,26,27,28],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},2000,"ESTIMATED",[37,57,65],{"type":38,"name":24,"description":39,"armGroupLabels":40,"otherNames":55},"DRUG","Intravenous\u002FSubcutaneous\u002FIntramuscular Injection\u002FInfusion",[41,42,43,44,45,46,47,48,49,50,51,52,53,54],"Substudy 1: CD Arm 1 Risankizumab monotherapy","Substudy 1: CD Arm 4 ABBV-466 (Risankizumab\u002FTrosunilimab)","Substudy 1: CD Arm 5 ABBV-466 (Risankizumab\u002FTrosunilimab)","Substudy 1: UC Arm 1 Risankizumab monotherapy","Substudy 1: UC Arm 4 ABBV-466 (Risankizumab\u002FTrosunilimab)","Substudy 1: UC Arm 5 ABBV-466 (Risankizumab\u002FTrosunilimab)","Substudy 2: CD Arm 1 Risankizumab monotherapy","Substudy 2: CD Arm 4 ABBV-7066 (Risankizumab\u002FABBV-701)","Substudy 2: CD Arm 5 ABBV-7066 (Risankizumab\u002FABBV-701)","Substudy 2: CD Arm 6 ABBV-7066 (Risankizumab\u002FABBV-701)","Substudy 2: UC Arm 1 Risankizumab monotherapy","Substudy 2: UC Arm 4 ABBV-7066 (Risankizumab\u002FABBV-701)","Substudy 2: UC Arm 5 ABBV-7066 (Risankizumab\u002FABBV-701)","Substudy 2: UC Arm 6 ABBV-7066 (Risankizumab\u002FABBV-701)",[56],"ABBV-066",{"type":38,"name":26,"description":39,"armGroupLabels":58,"otherNames":63},[59,60,42,43,61,62,45,46],"Substudy 1: CD Arm 2 Trosunilimab monotherapy","Substudy 1: CD Arm 3 Trosunilimab monotherapy","Substudy 1: UC Arm 2 Trosunilimab monotherapy","Substudy 1: UC Arm 3 Trosunilimab monotherapy",[64],"ABBV-382",{"type":38,"name":25,"description":39,"armGroupLabels":66},[67,68,48,49,50,69,70,52,53,54],"Substudy 2: CD Arm 2 ABBV-701 monotherapy","Substudy 2: CD Arm 3 ABBV-701 monotherapy","Substudy 2: UC Arm 2 ABBV-701 monotherapy","Substudy 2: UC Arm 3 ABBV-701 monotherapy",[72,76,79],{"measure":73,"description":74,"timeFrame":75},"Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission","Endoscopic remission is defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \\\u003C= 4 and no sub score greater than 1 in any individual variable, as scored by a central reviewer.","At Week 28",{"measure":77,"description":78,"timeFrame":75},"Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission","Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal appearance of mucosa; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).",{"measure":80,"description":81,"timeFrame":82},"Number of Participants with Adverse Events (AEs)","An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.","Up to 98 Weeks",[84,87,90,91,94,95,98,99,102,104,105,108,109,112],{"measure":85,"description":74,"timeFrame":86},"Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Remission","At Week 12",{"measure":88,"description":89,"timeFrame":86},"Crohn's Disease Specific: Percentage of Participants who Achieve Endoscopic Response","The Simple Endoscopic Score for Crohn's Disease (SES-CD) assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic Response is defined as a decrease in SES-CD \\> 50% from Baseline, and\u002For endoscopic remission, as scored by central reader.",{"measure":88,"description":89,"timeFrame":75},{"measure":92,"description":93,"timeFrame":86},"Crohn's Disease Specific: Percentage of Participants Achieving CDAI Clinical Remission","Clinical remission is defined as Crohn's disease activity index (CDAI)\\\u003C150.",{"measure":92,"description":93,"timeFrame":75},{"measure":96,"description":97,"timeFrame":86},"Crohn's Disease Specific: Percentage of Participants With Clinical Remission Per Stool Frequency\u002FAbdominal Pain Score (SF\u002FAPS)","SF\u002FAPS clinical remission is defined as the average daily SF ≤ 2.8 and not worse than Baseline AND average daily AP score ≤ 1 and not worse than Baseline.",{"measure":96,"description":97,"timeFrame":75},{"measure":100,"description":101,"timeFrame":86},"Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per modified Mayo Score (mMS)","Clinical remission on the mMS is defined as Endoscopy subscore = 0 or 1, AND Rectal bleeding subscore = 0, AND Stool frequency subscore \\\u003C= 1, AND not greater than baseline. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease \\[spontaneous bleeding, ulceration\\]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.",{"measure":103,"description":101,"timeFrame":75},"Ulcerative Colitis Specific: Percentage of Participants with Clinical Remission per mMS",{"measure":77,"description":78,"timeFrame":86},{"measure":106,"description":107,"timeFrame":86},"Ulcerative Colitis Specific: Percentage of Participants Achieving Endoscopic Improvement","Endoscopic improvement is defined as endoscopy subscore of 0 or 1. Endoscopies assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).",{"measure":106,"description":107,"timeFrame":75},{"measure":110,"description":111,"timeFrame":86},"Ulcerative Colitis Specific: Percentage of Participants who Achieve Clinical Response Per mMS","Clinical response per mMS is defined as decrease from baseline \\>=2 points and \\>=30%, PLUS a decrease in RBS \\>= 1 or an absolute RBS \\\u003C=1. The mMS is a composite score of UC disease activity based on the following 3 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed); ESS, scored from 0 (normal appearance of mucosa) to 3 (severe disease \\[spontaneous bleeding, ulceration\\]). The overall mMS ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer.",{"measure":110,"description":111,"timeFrame":75},"ALL","18 Years","75 Years",{"inclusion":117,"exclusion":125,"raw_text":134},[118,119,120,121,122,123,124],"Crohn's Disease Activity Index (CDAI) score of ≥ 220","Confirmed diagnosis of CD at least 90 days prior to Baseline","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.","Demonstrated failure of 1 or more therapy for CD","Confirmed diagnosis of UC at least 90 days prior to Baseline","Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3","Demonstrated failure of 1 or more therapy for UC",[126,127,128,129,130,131,132,133],"Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)","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","Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame","Participants with surgical bowel resection within the past 3 months prior to Baseline","Participants with \\>3 prior bowel resections","Participants with previous small bowel resection(s) of combined length \\>100 cm","Participants with prior colectomy (total or subtotal)","Participants with extent of disease limited to \\\u003C 10 cm of rectum","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",[136,137],"ADULT","OLDER_ADULT",[139,148,161,168,176,183,190,197,205,213,223,233,240,248,258,266,274,282,293,301,308,316,323,331,339,347,354,361,368,376,383,393],{"facility":140,"status":8,"city":141,"state":142,"zip":143,"country":144,"geoPoint":145},"Digestive Health Specialists \u002FID# 280827","Dothan","Alabama","36301","United States",{"lat":146,"lon":147},31.22323,-85.39049,{"facility":149,"status":8,"city":150,"state":151,"zip":152,"country":144,"contacts":153,"geoPoint":158},"Elite Clinical Studies \u002FID# 280477","Phoenix","Arizona","85018",[154],{"name":155,"role":156,"phone":157},"Site Coordinator","CONTACT","602-788-3437",{"lat":159,"lon":160},33.44838,-112.07404,{"facility":162,"status":8,"city":163,"state":151,"zip":164,"country":144,"geoPoint":165},"Gi Alliance - Arizona Digestive Health - Sun City \u002FID# 284084","Sun City","85351",{"lat":166,"lon":167},33.59754,-112.27182,{"facility":169,"status":8,"city":170,"state":171,"zip":172,"country":144,"geoPoint":173},"Clinnova Research \u002FID# 280509","Anaheim","California","92805",{"lat":174,"lon":175},33.83529,-117.9145,{"facility":177,"status":8,"city":178,"state":171,"zip":179,"country":144,"geoPoint":180},"Gastro Care Institute \u002FID# 281071","Lancaster","93534",{"lat":181,"lon":182},34.69804,-118.13674,{"facility":184,"status":8,"city":185,"state":171,"zip":186,"country":144,"geoPoint":187},"United Medical Doctors - Los Alamitos \u002FID# 281125","Los Alamitos","90720",{"lat":188,"lon":189},33.80307,-118.07256,{"facility":191,"status":8,"city":192,"state":171,"zip":193,"country":144,"geoPoint":194},"Inland Empire Liver Foundation - Rialto \u002FID# 280775","Rialto","92377",{"lat":195,"lon":196},34.1064,-117.37032,{"facility":198,"status":8,"city":199,"state":200,"zip":201,"country":144,"geoPoint":202},"Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue \u002FID# 280507","Colorado Springs","Colorado","80907",{"lat":203,"lon":204},38.83388,-104.82136,{"facility":206,"status":8,"city":207,"state":208,"zip":209,"country":144,"geoPoint":210},"Clinical Research of Osceola \u002FID# 280593","Kissimmee","Florida","34741",{"lat":211,"lon":212},28.30468,-81.41667,{"facility":214,"status":8,"city":215,"state":208,"zip":216,"country":144,"contacts":217,"geoPoint":220},"Research Associates of South Florida \u002FID# 280929","Miami","33134",[218],{"name":155,"role":156,"phone":219},"786-476-8790",{"lat":221,"lon":222},25.77427,-80.19366,{"facility":224,"status":8,"city":225,"state":208,"zip":226,"country":144,"contacts":227,"geoPoint":230},"Advanced Research Institute, Inc \u002FID# 281062","New Port Richey","34653",[228],{"name":155,"role":156,"phone":229},"727-835-3261",{"lat":231,"lon":232},28.24418,-82.71927,{"facility":234,"status":8,"city":235,"state":208,"zip":236,"country":144,"geoPoint":237},"Digestive And Liver Center Of Florida - Orlando \u002FID# 280924","Orlando","32825",{"lat":238,"lon":239},28.53834,-81.37924,{"facility":241,"status":8,"city":242,"state":243,"zip":244,"country":144,"geoPoint":245},"Gastroenterology Associates of Central Georgia \u002FID# 280464","Macon","Georgia","31201",{"lat":246,"lon":247},32.84069,-83.6324,{"facility":249,"status":8,"city":250,"state":243,"zip":251,"country":144,"contacts":252,"geoPoint":255},"Gastroenterology Consultants - Roswell \u002FID# 281235","Roswell","30076",[253],{"name":155,"role":156,"phone":254},"404-596-4480",{"lat":256,"lon":257},34.02316,-84.36159,{"facility":259,"status":8,"city":260,"state":261,"zip":262,"country":144,"geoPoint":263},"Treasure Valley Medical Research \u002FID# 281778","Boise","Idaho","83706",{"lat":264,"lon":265},43.6135,-116.20345,{"facility":267,"status":8,"city":268,"state":269,"zip":270,"country":144,"geoPoint":271},"Southwest Gastroenterology - Oak Lawn \u002FID# 280841","Oak Lawn","Illinois","60453",{"lat":272,"lon":273},41.71087,-87.75811,{"facility":275,"status":8,"city":276,"state":277,"zip":278,"country":144,"geoPoint":279},"Gastroenterology Health Partners \u002FID# 284144","Louisville","Kentucky","40218",{"lat":280,"lon":281},38.25424,-85.75941,{"facility":283,"status":8,"city":284,"state":285,"zip":286,"country":144,"contacts":287,"geoPoint":290},"Willis-Knighton Medical Center \u002FID# 280572","Shreveport","Louisiana","71103",[288],{"name":155,"role":156,"phone":289},"318-212-2863",{"lat":291,"lon":292},32.52515,-93.75018,{"facility":294,"status":8,"city":295,"state":296,"zip":297,"country":144,"geoPoint":298},"Vector Clinical Trials \u002FID# 280843","Las Vegas","Nevada","89128",{"lat":299,"lon":300},36.17497,-115.13722,{"facility":302,"status":8,"city":303,"state":303,"zip":304,"country":144,"geoPoint":305},"New York Gastroenterology Associates - Upper East Side \u002FID# 281767","New York","10075",{"lat":306,"lon":307},40.71427,-74.00597,{"facility":309,"status":8,"city":310,"state":311,"zip":312,"country":144,"geoPoint":313},"Dayton Gastroenterology - Englewood \u002FID# 284065","Englewood","Ohio","45415",{"lat":314,"lon":315},39.87756,-84.30217,{"facility":317,"status":8,"city":318,"state":311,"zip":319,"country":144,"geoPoint":320},"Gastro Intestinal Research Institute of Northern Ohio \u002FID# 283860","Westlake","44145",{"lat":321,"lon":322},41.45532,-81.91792,{"facility":324,"status":8,"city":325,"state":326,"zip":327,"country":144,"geoPoint":328},"University Gastroenterology - Providence - Staniford Street \u002FID# 280919","Providence","Rhode Island","02905",{"lat":329,"lon":330},41.82399,-71.41283,{"facility":332,"status":8,"city":333,"state":334,"zip":335,"country":144,"geoPoint":336},"Gastro One - Memphis \u002FID# 283948","Memphis","Tennessee","38104",{"lat":337,"lon":338},35.14953,-90.04898,{"facility":340,"status":8,"city":341,"state":342,"zip":343,"country":144,"geoPoint":344},"Novel Research - Bellaire \u002FID# 280925","Bellaire","Texas","77401",{"lat":345,"lon":346},29.70579,-95.45883,{"facility":348,"status":8,"city":349,"state":342,"zip":350,"country":144,"geoPoint":351},"Amel Med \u002FID# 283864","Georgetown","78628",{"lat":352,"lon":353},30.63269,-97.67723,{"facility":355,"status":8,"city":356,"state":342,"zip":357,"country":144,"geoPoint":358},"Integrity Advanced Therapeutics \u002FID# 283871","Houston","77090",{"lat":359,"lon":360},29.76328,-95.36327,{"facility":362,"status":8,"city":363,"state":342,"zip":364,"country":144,"geoPoint":365},"Southern Star Research Institute \u002FID# 280822","San Antonio","78229",{"lat":366,"lon":367},29.42412,-98.49363,{"facility":369,"status":8,"city":370,"state":371,"zip":372,"country":144,"geoPoint":373},"Washington Gastroenterology - Bellevue \u002FID# 283966","Bellevue","Washington","98004",{"lat":374,"lon":375},47.61038,-122.20068,{"facility":377,"status":8,"city":378,"state":371,"zip":379,"country":144,"geoPoint":380},"Washington Gastroenterology - Tacoma \u002FID# 284143","Tacoma","98405",{"lat":381,"lon":382},47.25288,-122.44429,{"facility":384,"status":8,"city":385,"state":371,"zip":386,"country":144,"contacts":387,"geoPoint":390},"The Vancouver Clinic \u002FID# 280497","Vancouver","98664",[388],{"name":155,"role":156,"phone":389},"360-397-3388",{"lat":391,"lon":392},45.63873,-122.66149,{"facility":394,"status":8,"city":395,"zip":396,"country":397,"geoPoint":398},"China Medical University Hospital \u002FID# 280630","Taichung","40447","Taiwan",{"lat":399,"lon":400},24.1469,120.6839,[402],{"name":403,"role":156,"phone":404,"email":405},"ABBVIE CALL CENTER","844-663-3742","abbvieclinicaltrials@abbvie.com",[407],{"name":408,"affiliation":13,"role":409},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":413,"biomarkers":415},[414,20],"Crohn Disease",[],{"nct_id":4,"found":417,"summary":418,"prompt_version":17},true,{"design":419,"status":420,"heading":421,"summary":422,"follow_up":423,"word_count":424,"commitments":425,"compensation":426,"drugs_mentioned":427},"This interventional study plans to enroll 2000 participants. It is a platform basket study evaluating different treatments in substudies.","completed","Study of Advanced Therapies for Crohn's Disease or Ulcerative Colitis","This study is looking at new treatments for adults with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC). These are types of inflammatory bowel disease that cause long-lasting inflammation in your digestive tract. The study will test the safety and effectiveness of advanced therapies, including risankizumab, trosunilimab, and ABBV-701. Researchers want to see if these treatments can help you achieve endoscopic remission (meaning the inflammation in your digestive tract looks better during an endoscopy). They will also track any side effects. You may be able to join if you are between 18 and 75 years old and have a confirmed diagnosis of CD or UC with specific levels of disease activity.","The study will measure adverse events for up to 98 weeks.",114,"Not specified in the trial record.","Not stated in the trial record.",[24,26,25]]