[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"crohns-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:crohns-disease":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,45,71,102,113,140,164,186,206,229,238,263,286,313,333,357,375,398,426,453,473,494,514,535,557],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053628","longitudinal-immunophenotyping-of-patients-with-inflammatory-bowel-disease-100053628",false,"NCT07619547","Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAffected Participant cohort:\n\n1. Adults 18 - 85 years of age\n2. History of:\n\n   1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and\u002For\n   2. a defined genetic syndrome\u002Fmutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n3. Presence of a referring community physician who would be able to manage care outside of NIH\n\nUnaffected family member of participant:\n\nImmediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD\n\n1. Adults 18 - 99 years of age\n2. In good general health\n3. No medical diagnosis of IBD\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unable or unwilling to provide informed consent\n2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures","ALL","18 Years","85 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","Background:\n\nInflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells.\n\nObjective:\n\nTo better understand IBD over time.\n\nEligibility:\n\nAdults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have clinic visits every 6 months for 3 years.\n\nOnce a year, they will have these procedures:\n\nA physical exam with blood and stool samples.\n\nUltrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines.\n\nMagnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines.\n\nColonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken.\n\nUpper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken.\n\nQuestionnaires. Participants will answer questions about their disease and their diet.\n\nMidyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires\n\nHealthy relatives will have 1 blood draw for genetic tests.",[25,26,27],"Inflammatory Bowel Disease","Crohn's Disease","Ulcerative Colitis",[29,30,31],"Immune System","Inflammation","gastroenterology","NOT_YET_RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-07-16",{"date":40,"type":21},"2036-06-01",{"name":42,"class":43},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100053921","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years","80 Years",{"count":55,"type":21},1200,"INTERVENTIONAL",[58],"PHASE3","The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[26],"RECRUITING",{"date":35,"type":36},{"date":64,"type":36},"2024-06-05",{"date":66,"type":21},"2029-11-12",{"name":68,"class":69},"Merck Sharp & Dohme LLC","INDUSTRY",499,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":56,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100053737","phase-2-study-of-advanced-therapies-for-the-treatment-of-adult-participants-with-moderately-to-severely-active-crohns-disease-or-ulcerative-colitis-100053737","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","75 Years",{"count":80,"type":21},2000,[82],"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.",[26,27],[86,87,88,89,90,91,92],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","2026-07-07",{"date":35,"type":36},{"date":96,"type":21},"2026-07-24",{"date":98,"type":21},"2031-10",{"name":100,"class":69},"AbbVie",30,{"id":103,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":105,"keywords":106,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":112,"locationsCount":44},"100641419",{"count":20,"type":21},[25,26,27],[29,30,31],"2026-07-01",{"date":109,"type":36},"2026-07-02",{"date":93,"type":21},{"date":40,"type":21},{"name":42,"class":43},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":132,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":44},"100634871","real-world-study-of-il-23-inhibitors-in-active-crohns-disease-100634871","NCT07545317","Real-World Study of IL-23 Inhibitors in Active Crohn's Disease","Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study","Inclusion Criteria:\n\n1. Age 18 to 75 years\n2. Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and\u002For histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria\n3. Active Crohn's disease with a baseline Crohn's Disease Activity Index (CDAI) score of 150 to 450, and at least one of the following objective inflammatory findings: (1) Endoscopic activity within 1 month before enrollment, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \\>=6 for ileocolonic or colonic disease, or SES-CD \\>=4 for isolated ileal disease, (2) Active intestinal inflammation on bowel ultrasound, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), (3) Serum C-reactive protein (CRP) above the upper limit of normal, (4) Fecal calprotectin (FC) \\>=250 ug\u002Fg\n4. Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors\n5. Prior treatment history for the IL-23 inhibitor cohort may include biologic-naive or biologic-experienced patients; prior exposure to TNF inhibitors, vedolizumab, or ustekinumab is permitted\n6. If receiving concomitant medications, doses should be stable for at least 2 to 4 weeks before enrollment, including oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or 5-aminosalicylic acid\n7. Able to understand the study procedures, provide written informed consent, and comply with follow-up and biospecimen collection requirements\n8. Additional criteria for the concurrent prospective TNF inhibitor cohort used in the nested comparative analysis: (1) Participants must be bio-naive, defined as no prior exposure to any biologic agent (including TNF inhibitors, vedolizumab, ustekinumab, etc.) or targeted small-molecule therapy (such as JAK inhibitors), (2) Participants must also meet Inclusion Criteria 1, 2, 3, 6, and 7 above, (3) Participants must be planned to initiate TNF inhibitor therapy in routine clinical practice\n\nExclusion Criteria:\n\n1. Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents\n2. Diagnosis of inflammatory bowel disease other than Crohn's disease, or other intestinal disorders that may confound diagnosis, including ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis\n3. Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction\n4. Active infection or high-risk infectious condition, including active tuberculosis, latent tuberculosis without appropriate prophylaxis, active hepatitis B or C, HIV infection, or severe\u002Frecurrent infection history\n5. Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence\n6. Pregnancy, breastfeeding, or planned pregnancy during the study period\n7. Severe systemic disease or other condition that, in the investigator's judgment, makes participation unsuitable, including severe cardiac, hepatic, or renal dysfunction, uncontrolled autoimmune disease, or psychiatric disease affecting adherence\n8. Inability to complete follow-up, poor compliance, or recent participation in another interventional clinical trial",{"count":121,"type":21},665,"The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are:\n\n* What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?\n* What are the clinical, endoscopic, biomarker, imaging, and safety outcomes during induction and maintenance treatment?\n\nThis is not a head-to-head randomized study. Treatments are selected by treating physicians as part of routine clinical care. For a nested comparative analysis, bio-naive participants treated with IL-23 inhibitors will be compared with a concurrent prospective cohort of bio-naive participants treated with TNF inhibitors to evaluate comparative effectiveness and safety.\n\nParticipants will:\n\n* Receive treatment chosen by their treating physicians as part of routine clinical care, including IL-23 inhibitors or TNF inhibitors\n* Attend study follow-up visits during induction and maintenance, including assessments at baseline, Week 12 and Week 52\n* Undergo routine clinical evaluations, which may include symptom assessment, laboratory tests, endoscopy, and imaging, as available\n* Be monitored for adverse events and treatment changes during the study\n* Optionally provide blood, stool, and other available samples for exploratory biomarker, microbiome, metabolomic, and other multi-omics analyses related to treatment response",[26],[86,125,126,127,128,129,130,131],"IL-23 inhibitor","TNF inhibitor","Bio-naive","Real-world study","Observational cohort","Clinical remission","Endoscopic remission",{"date":109,"type":36},{"date":134,"type":36},"2026-04-16",{"date":136,"type":21},"2028-08-31",{"name":138,"class":139},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":56,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":157,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":44},"100298622","phase-1-an-open-label-proof-of-consent-study-of-vorinostat-for-the-treatment-of-mdoerate-to-severe-crohn-s-disease-and-maintenance-therapy-with-ustekinumab-100298622","NCT03167437","An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab","An Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease, Ulcerative Colitis, and Chronic Granulomatous Disease Colitis Patients and Maintenance Therapy With Ustekinumab","* INCLUSION CRITERIA:\n\nIndividuals with moderate-to-severe CD, UC, and CGD colitis who are not controlled by and refractory to standard therapy will be eligible for inclusion into this study if they meet the following criteria:\n\n1. Are 18 to 65 years of age, inclusive, at enrollment date.\n2. Have a diagnosis of CD, UC, or CGD colitis that has been endoscopically or radiographically confirmed. A colonoscopy will be required at baseline to document mucosal disease activity. SES-CD for CD and CGD colitis will be obtained with minimum score of 7 and MES for UC patients will be obtained with minimum score of 2.\n3. Have active CD symptoms as defined by a CDAI score between 220 and 350, UC symptoms defined by a Mayo score of 6 to 10 (moderate) or 10 to 12 (severe), or CGD colitis symptoms defined as an HBI score of 8-16 (moderate) or \\> 16 (severe), and demonstrate active symptoms as defined by continued weight loss, abdominal pain and\u002For diarrhea not controlled by standard therapy.\n4. The participant must have active CD and UC symptoms (as noted above) and therefore have had an inadequate response to, loss of response to, or intolerance to at least 1 of the following agent groups in control of their disease (as defined below for each individual agent group: Corticosteroids or Immunomodulators or TNF-alpha antagonists or Anti-integrin antibodies or JAK inhibitors or IL-12p19 (IL-23) antagonists). No specific induction therapy or long-term treatment for CGD colitis patients has been defined; therefore all symptomatic patients will be evaluated for inclusion on individual basis.\n\n   a. Corticosteroids\n\n   i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone \\>=30 mg PO once daily (QD) for 2 weeks or intravenously (IV) for 1 week OR\n\n   ii. One failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg PO QD or to taper to below a dose of 9 mg of budesonide\n\n   OR\n\n   iii. History of intolerance of corticosteroids at the discretion of the principal investigator (PI) (including but not limited to Cushing s syndrome, osteopenia\u002Fosteoporosis, hyperglycemia, insomnia, or infection)\n\n   b. Immunomodulators\n\n   i. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (AZA) (\\>= 2.5 mg\u002Fkg\u002FDay) or 6-MP (\\>= 1.5 mg\u002Fkg\u002FDay) OR\n\n   ii. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of MTX (\\>= 25 mg\u002Fweek) OR\n\n   iii. History of intolerance of at least one immunomodulator (including but not limited to nausea\u002Fvomiting leading to discontinuation, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, or serious infection)\n\n   c. TNF-alpha antagonists with signs and symptoms of persistently active disease despite a history of receiving infliximab, adalimumab, or certolizumab at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like rash.\n\n   d. Anti-integrin antibodies:\n\n   with signs and symptoms of persistently active disease despite a history of receiving an anti-integrin antibody agent (natalizumab or vedolizumab) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like reaction.\n\n   e. JAK inhibitor:\n\n   with signs and symptoms of persistently active disease despite a history of receiving a JAK inhibitor (tofacitinib and ruxolitinib) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like reaction.\n\n   f. Anti-IL-12 p19 (IL-23) antibodies:\n\n   with signs and symptoms of persistently active disease despite a history of receiving an anti-IL-12p19 (IL-23) antibody agent (Skyrizi and Tremfya) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and\u002For lupus-like reaction.\n5. At the discretion of the PI, concomitant medications will be permitted if the following conditions are met prior to baseline assessment (Day-1):\n\n   a. 5-aminosalicylic acid (ASA)-based compounds are permissible if:\n\n   i. Oral 5-ASA-based compounds must be at a stable dose for at least 3 weeks prior to baseline or\n\n   ii. Recently discontinued oral 5-ASA-based compounds must have been discontinued at least 3 weeks prior to baseline or\n\n   iii. Rectal 5-ASA-based compounds are not permissible during the study and must have been discontinued at least 3 weeks prior to baseline.\n\n   b. Corticosteroids (e.g., prednisone, budesonide) are permissible if:\n\n   i. Oral corticosteroids must be at a prednisone-equivalent dose of \\\u003C= 40 mg\u002Fday, or 9 mg\u002Fday of budesonide, and have been at a stable dose for at least 3 weeks prior to baseline or\n\n   ii. Discontinuation of oral corticosteroids must have been completed at least\n\n3 weeks prior to baseline or\n\niii. Parenteral (subcutaneous, intramuscular, or IV) or rectal corticosteroids are not permitted during the study and must not have been used within a 3- week period prior to baseline\n\nc. CD, UC, or CGD colitis-specific antibiotics are permissible if using an antibiotic for treatment of CD,UC, or CGD colitis (i.e., metronidazole, ciprofloxacin, rifaximin, ampicillin, sulfonamide and tetracycline)\n\ni. Participants must have been using the antibiotic for at least 3 weeks before baseline at a stable dose or\n\nii. If not currently using a CD, UC, or CGD colitis-specific antibiotic, the stop date must have been at least 3 weeks prior to baseline.\n\nd. Immunomodulators are permissible if:\n\ni. Participants receiving chronic (i.e., \\>= 12 weeks) treatment with AZA, 6- MP, or MTX prior to baseline must be on a stable dose for at least 6-8 weeks prior to baseline and must continue on this same dose during the study. OR\n\nii. Participants who have discontinued therapy with AZA, 6-MP, or MTX must have stopped the medication at least 4 weeks prior to baseline. OR\n\niii. Participants must not have received therapy with other known immunomodulators (e.g. cyclosporine, tacrolimus, sirolimus, pentoxifylline, or mycophenolate mofetil) or experimental agents (e.g. granulocyte- or macrophage colony stimulating factor) for at least 8 weeks or 5 half-lives of agent from baseline, whichever is longer.\n\ne. The use of Anti-TNF, Anti-integrin, JAK inhibitors, Anti-IL-12p19 (IL-23) therapy or other biological therapy listed below will not be permitted and the following washout period will be required in order for participant to be eligible:\n\ni. Three months washout prior to baseline for certolizumab or natalizumab.\n\nii. Two months washout prior to baseline for adalimumab, infliximab, and vedolizumab, tofacitinib, ruxolitinib, Skyrizi and Tremfya.\n\niii. 8-week washout prior to baseline for cyclosporine, pimecrolimus, tacrolimus, and any other systemic immunosuppressant.\n\n6\\. Participants must have a primary medical care provider.\n\n7\\. Male participants must agree to employ birth control measures to prevent pregnancy in female partners from start of treatment and continuing through 3 months post treatment.\n\n8\\. Females of childbearing potential must not be breast-feeding, possibly or actually pregnant, must not have had unprotected intercourse for one month prior to dosing, and must agree not to become pregnant beginning from enrollment in the study to at least 6 months after the end of treatment. Participants must remain completely abstinent of potentially reproductive sexual intercourse (e.g. due to a committed lifestyle) or to consistently use BOTH a barrier method with a spermicide (male or female condom) AND ALSO one of the below listed methods of birth control:\n\n1. Continuous\u002Fdaily hormonal methods including oral contraceptive pills, patch, implant\u002Finjection, etc.\n2. Surgical sterilization of either partner, of sufficient duration to be effective, and NOT known to have failed.\n3. Intrauterine device.\n\n   EXCLUSION CRITERIA:\n\n   Individuals who meet ANY of the following criteria will be excluded from participation in this\n\n   study:\n   1. Presence of clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, or upper respiratory tract infection) within three months of screening.\n   2. History or presence of recurrent or chronic infection (e.g., viral infection \\[including hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV)\\], bacterial infection, systemic fungal infection, or syphilis).\n   3. Positive for tuberculosis (TB) via QuantiFERON-Gold (QFT-G). Individuals who are known to have received the tuberculosis vaccine will be administered the QFT-G. Patients cannot have received tuberculosis vaccine within 12 months prior to start of study and cannot receive tuberculosis vaccine while on study or within 12 months from the time of conclusion of study participation.\n   4. Has a history of active tuberculosis (TB) or a chest x-ray (CXR) with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic HBV, HCV, HIV, or opportunistic infections.\n   5. A conduction abnormality on baseline electrocardiogram (ECG) that in the opinion of a cardiologist, is deemed significant.\n   6. At the discretion of the principal investigator, off-label use of any small molecule therapeutics that are immune modulators (e.g., naltrexone) within 90 days of beginning screening or at any time during the last 30-days of the screening window.\n   7. Presence of abnormal hematological and biochemical parameters, including:\n\n      * Neutrophil count \\\u003C 1500 cells\u002Fmm3\n      * Hemoglobin \\\u003C 9 g\u002FdL\n      * Platelet count \\\u003C= 150,000 cells\u002Fmm3\n      * Creatinine \\>= 1.2 times the upper limit of normal (ULN)\n      * Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>= 1.5 times\n\n      ULN\n      * Prothrombin time-international normalized ratio (PT-INR) \\> 1.0 ULN\n      * Serum bilirubin level \\> 1.0 times ULN\n   8. Individuals on chronic anticoagulation medications.\n   9. Stool sample positive for GI pathogens potentially causing disease (as assessed by FilmArray GI panel for 22 viral, bacterial, and parasitic organisms that can cause infectious diarrhea \\[GI pathogen panel\\]). The principal investigator will consult with an infectious disease specialist to review results and decide whether treatment is warranted.\n   10. Presence of cytomegalovirus (CMV) infection as defined by positive immunohistochemical staining on tissue intestine biopsy.\n   11. History of low-grade or high-grade colonic mucosal dysplasia.\n   12. History of bowel surgery other than perianal (e.g., fistulotomy, seton placement, or abscess drainage) within 6 months prior to beginning the CDAI screening diary, Mayo scoring, or Harvey Bradshaw index or drawing screening blood samples.\n   13. Presence of surgical changes to gut anatomy that preclude administration of clinical activity indices; this includes but is not limited to ileostomy, colostomy, or subtotal colectomy with ileorectal anastomosis.\n   14. Known or suspected short bowel syndrome.\n   15. Requirement of parenteral, total parenteral, elemental oral, or nasogastric nutrition.\n   16. History or current evidence of cancer, other than non-melanomatous cancer of the skin, or participants that have undergone excision of basal cell carcinoma, squamous cell carcinoma of the skin. All patients receiving ustekinumab will be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment will be followed closely.\n   17. Unwillingness or inability to comply with study requirements.\n   18. Presence of only small bowel disease that is inaccessible by standard colonoscopy for harvest of research biopsies. Individuals with only upper gastrointestinal disease or only perianal fistulizing disease are also excluded for this reason.\n   19. Refusal to abstain from using COX-2 inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) throughout the study agent administration period.\n   20. Has uncontrolled diabetes\n   21. Is taking anti-seizure medication, such as valproic acid or its derivative (i.e., Depakote).\n   22. Presence of any condition that, in the opinion of the principal investigator, contraindicates participation in this study.\n   23. Has participated in another investigational trial within 8 weeks (or 5 half-lives of any investigational study agent), whichever is greater, prior to the pre-trial (screening) visit. The window will be derived from the last date of treatment on the previous trial.","65 Years",{"count":149,"type":21},35,[151,82],"PHASE1","Background:\n\nCrohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce the inflammation process of CD. This may then help to relieve symptoms of CD. Participants who respond to Vorinostat will be invited to an extension phase of treatment with Vorinostat and possibly a maintenance treatment using Ustekinumab.\n\nObjectives:\n\nTo see if vorinostat is safe for people with moderate-to-severe CD. To see if it is safe for people with moderate-to-sever CD to receive maintenance therapy using Ustekinumab after successful treatment of Vorinostat.\n\nEligibility:\n\nAdults 18-65 with moderate-to-severe CD that medicine is not controlling.\n\nDesign:\n\nPhase I is screening. It may last 120 days. Participants will have:\n\nPhysical exam\n\nMedical history\n\nTests of blood, urine, and stool samples\n\nHeart test\n\nQuestionnaires\n\nTuberculosis skin test\n\nThey may have a colonoscopy and lymphapheresis collection. These will be explained in a separate consent.\n\nThey will keep a diary of symptoms.\n\nPhase II is treatment using Vorinostat. It will take 12-13 weeks. Participants will take the study drug by mouth twice daily for 12 weeks. They will get a weekly phone call to talk about how the drug makes them feel. They will have blood taken regularly. Every 4 weeks, they will have a check-up that will repeat some screening tests.\n\nPhase III extension treatment of Vorinostat for an additional 6 months for those who respond to vorinostat and it is safe for them to continue treatment. Participants will continue to receive weekly calls to talk about how the drug makes them feel. They will have blood taken regularly. Every 3 months, they will have a check-up that will repeat some screening tests.\n\nPhase IV: is maintenance therapy for 2 years with Ustekinumab. Participants will receive a one time loading dose of ustekinumab, and then will receive the approved maintenance dose once every 8 weeks, at which time they will return to the NIH Clinical Center for evaluation. The participant will get a phone call 3 days after each dose and again 2 weeks later to see how the drug makes them feel. After two years of receiving treatment with ustekinumab the participant will have an end of study visit, where some of the screening tests, including a colonoscopy, will be repeated....",[26],[155,156],"Reduce Symptoms of Crohn's Disease","HDAC Inhibitors",{"date":109,"type":36},{"date":159,"type":36},"2017-10-30",{"date":161,"type":21},"2035-06-30",{"name":163,"class":43},"National Institute of Allergy and Infectious Diseases (NIAID)",{"id":165,"slug":166,"hasResults":12,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":172,"targetDuration":4,"studyType":56,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100607159","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-crohns-disease-100607159","NCT07184931","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Induction Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","STARSCAPE-1","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Screening. Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active Crohn's Disease (CD) for at least 3 months prior to baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies (ATs)\n\nExclusion Criteria:\n\n* Participants with Ulcerative Colitis (UC) or indeterminate colitis\n* Participants with two entire missing segments of the: terminal ileum, right colon transverse colon, sigmoid and left colon, and rectum\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapy prior to baseline\n* Participants receiving prohibited medications or therapies\n* Participants with previous exposure to anti-TL1A investigational therapy\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":173,"type":21},980,[58],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study, comprised of 3 sub-studies, to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active CD. Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* Up to 5-week Screening Period.\n* 12-week Sub-Study 1 (Single Arm Open-Label Feeder Induction) or Sub-Study 2 (Pivotal Induction).\n* 12-week Sub-Study 3 (Extended Induction for non-responders).\n* 6 weeks (45 days) follow-up period for participants who do not enroll into the Pivotal Maintenance Study (EFC18327). The treatment duration will be up to 12 weeks in each sub-study.\n\nThe number of scheduled study visits for participants who continue to the Pivotal Maintenance Study (EFC18327) will be up to 8 (Sub-Study 1 and Sub-Study 2) and up to 15 for participants who enroll in Sub-Study 3.",[26],"2026-06-30",{"date":107,"type":36},{"date":180,"type":36},"2025-10-01",{"date":182,"type":21},"2029-05-14",{"name":184,"class":69},"Sanofi",301,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":193,"targetDuration":4,"studyType":56,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":4},"100624002","phase-2-a-study-of-zasocitinib-tak-279-in-adults-with-active-crohns-disease-100624002","NCT07403968","A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease","An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease","Inclusion Criteria:\n\n1. Men and women aged 18 to 75 years can participate in the study.\n2. Must have been diagnosed with Crohn's disease (CD) at least 1 month (30 days) before study start.\n3. Must have received other treatments for CD earlier but no longer tolerate these treatments or the treatment no longer helps.\n\nExclusion Criteria\n\n1. Cannot have another condition that causes swelling (inflammation) in the bowel.\n2. Cannot have complications of CD which may require surgery.\n3. Cannot have current abscesses or abscesses that have been treated within 6 weeks before study start.\n4. Cannot have had a removal of parts of the bowel within half a year (6 months) before study start.\n5. Cannot have had any surgery inside the belly (intraabdominal) within 3 months before study start.\n6. Cannot have or had a J-pouch.\n7. Cannot have had infections up to 2 months (8 weeks) before study start.\n8. Cannot have given blood or plasma within 1 month (30 days) before study start.\n9. Cannot tolerate having blood taken with a needle from a vein (venipuncture).\n\nAdditional entry criteria will be discussed with the study doctor.",{"count":194,"type":21},20,[82],"Crohn's disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib's mechanism of action in CD and evaluate how safe this treatment is.\n\nThe participants will be treated with zasocitinib for 3 months (12 weeks) and will need to undergo a test where a doctor uses a thin, flexible tube with a tiny camera to look inside the large bowel (colon) and the end of the small bowel (ileum); this test is called ileocolonoscopy.\n\nDuring the study, participants will visit the study clinic several times.",[26],"2026-06-29",{"date":107,"type":36},{"date":201,"type":21},"2026-07-15",{"date":203,"type":21},"2028-03-30",{"name":205,"class":69},"Takeda",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":214,"targetDuration":4,"studyType":56,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":228},"100560759","phase-4-a-study-of-vedolizumab-in-adults-with-ulcerative-colitis-or-crohns-disease-in-the-community-setting-100560759","NCT06581328","A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting","A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting","PANORAMA","Inclusion Criteria\n\nTo be eligible to participate in this study, participants must meet all the following criteria:\n\n1. In the investigator's opinion, the participant can understand and comply with protocol requirements.\n2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.\n3. The participant is 18 to 80 years of age at the time of signing the ICF.\n4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).\n5. If participant is a woman of childbearing potential (WOCBP):\n\n   1. Agrees to use at least 1 form of highly effective contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab.\n   2. Agrees to avoid donating ova from signing the ICF throughout the duration of the study and for 18 weeks after the last dose of vedolizumab.\n   3. Has a negative urine pregnancy test within 3 days before first dose of vedolizumab.\n   4. Agrees to forego breastfeeding from first dose of vedolizumab through 18 weeks after the last dose of vedolizumab.\n6. If participant is a fertile man:\n\n   1. Agrees to use contraception from signing the ICF until at least 18 weeks after the last dose of vedolizumab\n   2. Agrees to avoid donating sperm throughout the study and for 18 weeks after the last dose.\n7. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:\n\n   1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \\>=6 (\\>=4 if isolated ileal disease) at screening OR\n   2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy subscore of 2 to 3 at screening\n8. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.\n9. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and\u002For advanced therapy.\n\nExclusion Criteria\n\nParticipants who meet any of the following exclusion criteria will be excluded from participation in this study:\n\n1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \\[AMG 181\\]) at any time prior to screening.\n2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.\n3. Use of corticosteroid enemas\u002Fsuppositories within 2 weeks prior to screening (for UC and CD).\n4. In the investigator's opinion the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has (medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients) (Food and Drug administration \\[FDA\\] 2024).\n5. Received any investigational biologic therapy \\\u003C= 6 months prior to screening.\n6. The participant has received an advanced treatment for an approved indication other than CD or UC. Advanced therapy include: TNF inhibitors (e.g. infliximab, adalimumab, certolizumab pegol), and IL 12\u002F23 antagonist (e.g. ustekinumab, mirikizumab, risankizumab); and small molecules include JAK inhibitor (e.g. tofacitinib, upadacitinib) and sphingosine-1-phosphate (S1P) receptor modulator (e.g. etrasimod, ozanimod).\n7. The participant has any evidence of an active infection during screening.\n8. Ileostomy, colostomy, severe, or symptomatic stenosis of the intestine or short bowel syndrome.\n9. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to or is at risk of undergoing major surgery during the study period.\n10. History of malignancy, except for the following: adequately treated nonmetastatic basal cell skin cancer; squamous cell skin cancer that has been adequately treated and that has not recurred for at least 1 year prior to screening; and history of cervical carcinoma in situ that has been adequately treated and that has not recurred for at least 3 years prior to screening. Participants with a remote history of malignancy (example, greater than (\\>) 10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received; this must be discussed with the sponsor on a case-by-case basis prior to enrollment.\n11. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion.\n12. Has laboratory abnormalities during the screening period.",{"count":215,"type":21},400,[217],"PHASE4","Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).\n\nParticipants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.\n\nDuring the study, participants will visit their study clinic several times.",[27,26],"2026-06-25",{"date":222,"type":36},"2026-06-26",{"date":224,"type":36},"2025-03-27",{"date":226,"type":21},"2028-06-01",{"name":205,"class":69},101,{"id":230,"slug":4,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":231,"targetDuration":4,"studyType":56,"phases":232,"briefSummary":59,"conditions":233,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":237,"locationsCount":70},"100549191",{"count":55,"type":21},[58],[26],{"date":198,"type":36},{"date":64,"type":36},{"date":66,"type":21},{"name":68,"class":69},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":245,"targetDuration":4,"studyType":56,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"100644929","phase-2-a-phase-ii-study-of-h021-enteric-coated-tablets-for-moderately-to-severely-active-crohns-disease-100644929","NCT07677514","A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of H021 Enteric-coated Tablets in Patients With Moderately to Severely Active Crohn's Disease (CD)","Inclusion Criteria:\n\n1. Age ≥18 years to ≤75 years, regardless of gender;\n2. Diagnosis of Crohn's disease (CD) ≥12 weeks prior to screening, with endoscopic and histopathological evidence required for CD confirmation. If no histological results are available at screening, biopsy results from the screening period may be used;\n3. Have active moderately to severely active CD, defined as: CDAI score between 220 and 450 (inclusive), and evidence of active mucosal inflammation (involving at least the ileum and\u002For colon) confirmed by ileocolonoscopy (central reading) performed during the screening period, with a Simplified Endoscopic Score for Crohn's Disease (SES-CD) ≥6 for ileocolonic or colonic disease (SES-CD ≥4 for isolated ileal disease);\n4. Inadequate response, loss of response, or intolerance to one or more of the following treatments (including corticosteroids, immunosuppressants \\[azathioprine, 6-mercaptopurine, methotrexate\\], and advanced therapies such as anti-TNF, anti-integrin, anti-IL-23 or anti-IL-12\u002F23, JAK inhibitors) (failure to 5-aminosalicylic acid \\[5-ASA\\] alone does not meet the study inclusion requirements) (it will be determined by the investigator based on the assessment criteria; see Appendix 13.1 for details);\n5. If the patient is using the following medications for CD at screening, they must have been on stable treatment during the screening period and the requirements during the study are as follows:\n\n   * Oral 5-aminosalicylic acid (5-ASA) stable treatment for ≥2 weeks prior to screening endoscopy and must remain stable during the study;\n   * Oral corticosteroids equivalent to prednisone dose ≤20 mg\u002Fday or budesonide ≤9 mg\u002Fday, stable for ≥2 weeks prior to endoscopy during screening and must remain stable during the double-blind induction treatment period;\n   * Oral immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate) stable treatment for ≥4 weeks prior to screening endoscopy and must remain stable during the study. Patients taking methotrexate are advised to supplement with folic acid (specific dose determined by the investigator) unless contraindicated;\n6. Female participants must meet one of the following conditions:\n\n   1. Postmenopausal status: Postmenopausal is defined as the absence of menstruation for at least 12 consecutive months without other medical explanation. For women not using hormonal contraception or hormone replacement therapy (HRT), menopausal status can be confirmed by detecting follicle-stimulating hormone (FSH) levels within the menopausal range.\n\n      Note: For women receiving HRT whose menopausal status is uncertain, if they wish to continue HRT during the study, a highly effective non-estrogen-containing hormonal contraceptive method must be used (see Section 7.4.1.8).\n\n      Or\n   2. Permanent infertility: including but not limited to hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n\n      Or\n   3. Women of childbearing potential: May only be enrolled if they and their non-sterilized male sexual partner agree to consistently use highly effective contraception (as defined in Section 7.4.1.8) from the time of signing the informed consent form until at least 30 days after the last dose of study treatment.\n\n      Note: A woman of childbearing potential is defined as a woman who has experienced menarche, is premenopausal, and has not undergone permanent sterilization. The use of contraceptive methods must comply with the relevant regulations regarding contraceptive requirements for clinical studies in the region where the participant is located.\n   4. Female participants must not be pregnant or breastfeeding from the screening period until 30 days after the last dose of study treatment (or longer as required by local regulations), and must have no plans to become pregnant or donate eggs.\n\n   Male participants:\n   1. Male participants who have not undergone vasectomy and whose sexual partner is a woman of childbearing potential must agree to use acceptable contraception (see Section 7.4.1.8) from the first dose until at least 90 days after the last dose.\n   2. Male participants must have no plans to father a child or donate sperm during the study and for 90 days after the last dose of study treatment.\n7. Voluntarily sign the ICF, willing and able to comply with all planned visits, treatment plan, study assessments (including endoscopy and daily diary entry), laboratory tests, lifestyle considerations, and other study procedures.\n\nExclusion Criteria:\n\n1. History of allergy to any component of the investigational product (including the investigational drug and placebo);\n2. Study participants who have previously received treatment that upregulates microRNA-124 (miR-124) (e.g., ABX464);\n3. Study participants who have failed more than three advanced therapies for CD, or who have failed two advanced therapies for CD with different mechanisms of action;\n4. Treatment with cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or thalidomide within 4 weeks prior to screening endoscopy;\n5. Treatment with biologics (e.g., anti-TNF, anti-integrin, anti-IL-23 or anti-IL-12\u002F23) within 8 weeks prior to screening endoscopy or within 5 half-lives of the drug (whichever is longer);\n6. Study participants who have previously received natalizumab (or any other α4β1 integrin antagonist) treatment;\n7. Treatment with small-molecule targeted drugs (e.g., upadacitinib) within 4 weeks prior to screening endoscopy or within 5 half-lives of the drug (whichever is longer);\n8. Treatment with intravenous medium- to high-dose corticosteroids (e.g., methylprednisolone 60 mg\u002Fday or hydrocortisone 300 mg\u002Fday) within 2 weeks prior to screening endoscopy;\n9. Discontinuation of oral immunosuppressants (azathioprine, 6-mercaptopurine, methotrexate) within 4 weeks prior to screening endoscopy, or discontinuation of oral 5-ASA or oral corticosteroids within 2 weeks prior to screening endoscopy;\n10. Treatment with rectal aminosalicylate preparations or corticosteroids, other enemas\u002Fsuppositories (except those required for endoscopy) within 2 weeks prior to screening endoscopy;\n11. Total enteral nutrition or total parenteral nutrition, or fecal microbiota transplantation within 4 weeks prior to screening endoscopy;\n12. Known symptomatic intestinal strictures and\u002For inability to pass the endoscope due to stricturing lesions;\n13. Evidence or clinical suspicion of other forms of inflammatory bowel disease (ulcerative colitis, indeterminate colitis) or concurrent other active gastrointestinal inflammatory diseases (including but not limited to infectious colitis, ischemic colitis, radiation colitis, microscopic colitis, and uncontrolled celiac disease);\n14. Presence of untreated active external fistula or perianal fistula or abscess at screening. Patients with stable fistulas without abscess and with minimal or no drainage may be enrolled. For recent skin abscesses and perianal abscesses, if drainage and treatment have been completed at least 3 weeks prior to screening colonoscopy (at least 8 weeks for intra-abdominal abscesses) and no further surgery is anticipated, inclusion is allowed;\n15. Conditions related to CD surgery at screening:\n\n    1. Current ostomy or ileal pouch;\n    2. Absence of more than 2 of the following 5 complete intestinal segments: terminal ileum, right colon, transverse colon, left colon, and sigmoid colon and rectum;\n    3. Previous small bowel resection with total length \\>100 cm or short bowel syndrome;\n    4. Intestinal resection surgery within 3 months prior to baseline;\n    5. Any other manifestation that may require surgery during the study period;\n16. Study participants with evidence of colonic dysplasia (excluding completely resected low-grade dysplasia lesions), adenoma (excluding completely resected colonic adenomatous polyps), or neoplasia;\n17. History of lymphoproliferative disorders, including lymphoma, or symptoms or signs suggestive of possible lymphoproliferative disorders, such as lymphadenopathy and\u002For splenomegaly;\n18. History of malignancy in the past 5 years (participants with basal cell carcinoma, localized squamous cell carcinoma of the skin, or carcinoma in situ of the cervix may enter this study if they have been cured for at least 12 months prior to signing the ICF);\n19. Presence of unstable or poorly controlled diseases, including but not limited to cardiovascular, cerebrovascular, respiratory, gastrointestinal (except CD), hepatic, renal, endocrine, hematologic, or neurological diseases, which may affect patient safety in the study or confound efficacy assessments;\n20. History of acute myocardial infarction or unstable angina, severe arrhythmia (multifocal frequent ventricular premature beats, ventricular tachycardia, ventricular fibrillation) within the past 6 months; New York Heart Association (NYHA) functional class III-IV. Study participants with a family or personal history of congenital or acquired long QT syndrome, or with significantly prolonged QTc interval at baseline (QTcF \\>450 msec for male study participants, QTcF \\>470 msec for female study participants);\n21. Abnormal serological virology tests, including any of the following:\n\n    1. Positive for hepatitis B surface antigen (HBsAg);\n    2. Positive for hepatitis B core antibody (HBc Ab) with detectable HBV-DNA;\n    3. Positive for hepatitis C antibody (HCV-Ab) (study participants who have been successfully treated and are ≥1 year post-treatment without recurrence and with undetectable HCV RNA are eligible for this study);\n    4. Positive for human immunodeficiency virus antibody (HIV-Ab) or Treponema pallidum antibody (TP-Ab);\n22. Active tuberculosis or latent tuberculosis without prophylactic treatment (for those with latent tuberculosis infection, those receiving prophylactic treatment may be enrolled); or study participants with a history of tuberculosis not fully cured;\n23. Positive Clostridioides difficile test at the screening visit; if Clostridioides difficile is positive, the study participant may be treated and retested ≥2 weeks after completing treatment;\n24. Study participants with chronic or recurrent Grade 3 or 4 infection within 2 months prior to screening or with a history of opportunistic infection during periods without immunosuppressive therapy; herpes zoster reactivation within 2 months prior to screening; active infection at screening, or any severe infection episode requiring hospitalization or intravenous antibiotics within 1 month prior to screening or during screening (fungal infection of the nail bed is acceptable);\n25. Any other history of infection that, in the investigator's opinion, may worsen if the study participant participates in the study;\n26. Abnormal laboratory tests during screening, including any of the following:\n\n    1. Neutrophil count \\\u003C0.75x109\u002FL;\n    2. Hemoglobin ≤80 g\u002FL;\n    3. Platelet count \\\u003C100x109\u002FL;\n    4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the upper limit of normal (ULN);\n    5. Total bilirubin \\>1.5 times ULN (if the direct bilirubin fraction is \\\u003C35%, isolated bilirubin \\>1.5×ULN is acceptable); Participants with isolated indirect hyperbilirubinemia consistent with Gilbert's syndrome may be enrolled if other hepatic function parameters are within acceptable limits;\n    6. Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula without race adjustment (the calculation method is presented in 13.2);\n27. History of organ transplantation requiring ongoing immunosuppressive therapy;\n28. Receipt of any live vaccine within 3 months prior to randomization; or planned receipt of any live vaccine during the study;\n29. Contraindications to colonoscopy;\n30. History of drug abuse or alcohol abuse\u002Fdependence;\n31. Suspected or confirmed pregnancy, or lactating female;\n32. Participation in another drug\u002Fdevice clinical study and use of the investigational drug\u002Fdevice within 3 months prior to randomization;\n33. Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in this study;\n34. Treatment with a narrow therapeutic index CYP1A2 substrate drug (e.g., clozapine, theophylline, ropinirole, warfarin, methadone) within 5 half-lives prior to the start of study treatment",{"count":246,"type":21},156,[82],"This study employs a multicenter, randomized, double-blind, placebo-controlled, parallel-group, continuous treatment design to evaluate the efficacy, safety, PPK characteristics, and PD effects of H021 Enteric-coated Tablets during both the induction and maintenance treatment periods in patients with moderately to severely active CD.\n\nThis study consists of an up to 4-week screening period, a 12-week double-blind induction treatment period, a 40-week double-blind maintenance treatment period or open-label extension treatment period, and a 4-week safety follow-up period.",[26],[251,252,253],"H021 Enteric-coated Tablets","Moderately to Severely Active Crohn's Disease (CD)","Phase II","2026-06-24",{"date":177,"type":36},{"date":257,"type":21},"2026-07-12",{"date":259,"type":21},"2027-11-12",{"name":261,"class":69},"Jiangsu Carephar Pharmaceutical Co., Ltd.",24,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":271,"targetDuration":4,"studyType":56,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100558240","phase-2-study-of-targeted-therapies-for-the-treatment-of-adult-participants-with-moderate-to-severe-crohns-disease-100558240","NCT06548542","Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease","A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease","Target CD","Inclusion Criteria:\n\n* Participants' body weight must be \\>= 40 kg at Baseline.\n* Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.\n* CDAI \\>= 220 at Baseline.\n* Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \\>= 6 for ileocolonic or colonic disease or SES-CD of \\>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.\n* Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and\u002For TaTs. TaTs include biologics and\u002For targeted small molecules.\n\nExclusion Criteria:\n\n* Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.\n* Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification\u002Fquantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.\n* Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.",{"count":272,"type":21},540,[82],"Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.\n\nThe medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide.\n\nRisankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.\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, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[26],[26,88,90,277,278],"Lutikizumab","ABBV-8736",{"date":222,"type":36},{"date":281,"type":36},"2024-09-04",{"date":283,"type":21},"2030-01",{"name":100,"class":69},255,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":56,"phases":295,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":44},"100644584","online-pain-education-for-crohns-disease-and-ulcerative-colitis-100644584","NCT07671313","Online Pain Education for Crohn's Disease and Ulcerative Colitis","Randomized Controlled Trial of Online Pain Education Programs for Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Physician-confirmed diagnosis of Crohn's disease or ulcerative colitis\n* Chronic pain (visceral and\u002For somatic) related to IBD for at least 3 months\n* NIH PROMIS Pain Interference scale T-score ≥60\n* Medically stable, defined as:\n\n  1. No acute IBD-related hospitalization within the past 3 months; AND\n  2. No planned IBD surgery or planned therapeutic escalation within the next 2 months, including initiation of a new advanced therapy, dose escalation or switch of advanced therapy, or corticosteroid taper\n* Able to understand and complete questionnaires independently in English\n* Access to an internet-enabled device for online surveys and intervention access.\n\nExclusion Criteria:\n\n* Cognitive impairment or other condition that, in the opinion of the investigators, would interfere with protocol participation\n* Current use of standing opioid medications, given the often severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia\n* Prior participation in cognitive behavioral therapy (CBT) specifically targeting chronic IBD-related pain",{"count":294,"type":21},60,[296],"NA","Through a pilot randomized controlled trial (RCT), we aim to test the feasibility and preliminary impact of two online pain educations programs among adult patients with inflammatory bowel disease (IBD) who experience chronic pain. Each online program can be accessed on the patient's personal device, and will take about 2 hours to complete. Clinical outcomes (pain intensity, pain interference, quality of life) will be assessed via online surveys at baseline and then weekly for 8-weeks post-treatment.",[26,299,300],"Ulcerative Colitis (UC)","Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)",[302,303,304],"Pain Education","Remote Monitoring","Chronic pain","2026-06-22",{"date":222,"type":36},{"date":308,"type":21},"2026-08",{"date":310,"type":21},"2027-09",{"name":312,"class":139},"Cedars-Sinai Medical Center",{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":7},"100598560","a-study-to-assess-the-effectiveness-of-second-line-therapy-of-upadacitinib-and-risankizumab-in-adult-participants-with-crohns-disease-in-a-real-world-setting-100598560","NCT07073079","A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting","Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)","CROHNOS","Inclusion Criteria:\n\n* Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmed by clinical, and\u002For endoscopic\u002Fhistological indexes\n* Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fist line (1L) therapy for at least 6 months; clinical documentation available in medical charts for the previous 2 years or since the beginning of the 1L therapy\n\nExclusion Criteria:\n\n* Any condition included in the \"warning and precautions\" and \"contraindications\" section of the approved local upadacitinib\u002Frisankizumab label\n* Participants previously exposed to upadacitinib\u002Frisankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD",{"count":322,"type":21},250,"Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will evaluate the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world setting.\n\nUpadacitinib and risankizumab are approved drugs for treating CD. Approximately 250 participants who are prescribed upadacitinib or risankizumab by their physician in accordance with local label will be enrolled in 25 sites across Italy.\n\nParticipants will receive upadacitinib or risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 18 months.\n\nNo additional burden for participants in this trial is expected.",[26],[26,326,88],"Upadacitinib",{"date":254,"type":36},{"date":329,"type":36},"2025-07-14",{"date":331,"type":21},"2027-12",{"name":100,"class":69},{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":16,"minAge":341,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":56,"phases":345,"briefSummary":346,"conditions":347,"keywords":348,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":350,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":355,"locationsCount":356},"100541643","phase-3-crohns-disease-efficacy-safety-and-pharmacokinetics-of-upadacitinib-in-pediatric-subjects-with-moderately-to-severely-active-crohns-disease-100541643","NCT06332534","Crohn's Disease: Efficacy, Safety, and Pharmacokinetics of Upadacitinib in Pediatric Subjects With Moderately to Severely Active Crohn's Disease","A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Pediatric Subjects With Moderately to Severely Active Crohn's Disease and Inadequate Response, Intolerance, or Medical Contraindications to Corticosteroids, Immunosuppressants, and\u002For Biologic Therapy","U-EMPOWER","Inclusion Criteria:\n\n* Weight at Screening and Baseline must be \\>= 10 kg\n* Moderate to severe Crohn's Disease (CD) defined as Pediatric Crohn's Disease Activity Index (PCDAI) \\> 30 and endoscopic evidence of mucosal inflammation as documented by a centrally read SES-CD of \\>= 6 (or SES-CD of \\>=4 for isolated ileal disease) excluding the presence of narrowing component.\n* Documented diagnosis of CD prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and\u002For malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of CD, in the assessment of the investigator, must be available\n* Demonstrated an inadequate response, loss of response, or intolerance to corticosteroids, immunomodulators (IMMs), and\u002For biologic therapy or in whom use of those therapies is medically contraindicated. For participants in the US and South Korea, participants must have demonstrated an inadequate response, loss of response, or intolerance to one or more anti-TNFs (tumor necrosis factor).\n\nExclusion Criteria:\n\n* History of:\n\n  * A diagnosis of CD prior to 2 years of age.\n  * Currently known complications of CD such as:\n\n    * Active abscess (abdominal or perianal);\n    * Symptomatic bowel strictures;\n    * More than 2 missing segments of the following 5 intestinal segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;\n    * Ostomy or ileoanal pouch;\n    * Surgical bowel resection within the past 3 months prior to Baseline, or a history of more than 3 bowel resections.\n* Japan participants only: positive result of beta-D-glucan or two consecutive indeterminate results of beta-D-glucan during the Screening period (screening for Pneumocystis jiroveci infection)\n* History of any of the following:\n\n  * Current diagnosis of ulcerative colitis (UC), indeterminate colitis, or monogenic inflammatory bowel disease (IBD);\n  * Fulminant colitis or toxic megacolon;\n  * Gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment including history of volvulus and\u002For intussusception (telescoping of bowels);\n* Current diagnosis of any primary immune deficiency\n* Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding\u002Fsegmentation are not excluded.","2 Years","17 Years",{"count":344,"type":21},110,[58],"Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most often affecting the bowels. It can cause many different symptoms including abdominal pain, diarrhea, tiredness, and weight loss. This study will assess how safe and effective oral Upadacitinib is in treating moderately to severely active Crohn's Disease in pediatric participants aged 2 to 18 years old who have had inadequate response, loss of response, intolerance, or medical contraindications to corticosteroids, immunosuppressants, and\u002For biologic therapy.\n\nUpadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active CD and is being developed for moderate- to severely active CD in pediatric participants. This study is conducted in 2 periods: Period 1 is comprised of two phases: a 12-week open-label induction phase which means that the study doctor and participants know that participants will receive UPA Dose-A (or the adult equivalent based on body weight) followed by a 52-week double-blind maintenance phase meaning that neither the participants nor the study doctors will know which dose of upadacitinib will be given (UPA Dose B or Dose C). Period 2 is a 156-week open-label extension of Period 1. Approximately 110 pediatric participants with moderate to severely active CD will be enrolled at approximately 92 sites worldwide.\n\nParticipants will receive upadacitinib oral tablets once daily or oral solution twice daily at approximately the same time each day, with or without food. Participants will have a safety follow up for 30 days after discontinuation from any time point within the study.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular (weekly, monthly) visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[26],[26,326,349],"RINVOQ",{"date":254,"type":36},{"date":352,"type":36},"2024-08-08",{"date":354,"type":21},"2034-12",{"name":100,"class":69},85,{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":16,"minAge":147,"maxAge":4,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":366,"conditions":367,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":372,"leadSponsor":374,"locationsCount":44},"100612225","a-study-on-infections-in-adults-with-ulcerative-colitiscrohns-disease-100612225","NCT07250815","A Study on Infections in Adults With Ulcerative Colitis\u002FCrohn's Disease","Infection Outcomes Among Advanced Therapy-naive Older Adult US Patients With UC\u002FCD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025","Inclusion Criteria:\n\nUC Study Cohort:\n\nParticipants will be included if they had:\n\n-Greater than or equal to (\\>=) 1 medical (for Medicare fee-for-service \\[FFS\\], Part A\u002FB) or pharmacy claim (for Medicare FFS, Medicare Part D) for an approved AMT for UC during the participant identification period.\n\nNote: Claim should be on or after the food and drug administration (FDA) treatment-specific approval dates for each drug.\n\nThe date of the first claim during the participant identification period will be designated the Index Date, and the corresponding AMT, the index AMT.\n\n* \\>=2 medical (for Medicare FFS, Part A\u002FB) claims, at least 30 days apart, with an ICD-10-CM code for UC during the baseline period or on the Index Date.\n* Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.\n\nCD Study Cohort:\n\nParticipants will be included if they had:\n\n\\- \\>=1 medical (for Medicare FFS, Part A\u002FB) or pharmacy claim (for Medicare FFS, Part D) for an approved AMT for CD during the Participant Identification Period.\n\nNote: Claim should be on or after the FDA treatment-specific approval dates for each drug.\n\nThe date of the first claim during the Patient Identification Period will be designated the Index Date, and the corresponding AMT, the index AMT.\n\n* \\>=2 medical (for Medicare FFS, Part A\u002FB) claims, at least 30 days apart, with an ICD-10-CM code for CD during the Baseline Period or on the Index Date.\n* Continuous enrollment in either Medicare FFS or Medicare Advantage medical and pharmacy benefits during the Baseline Period.\n\nIf a participant has both a UC and CD diagnosis during the baseline period or on the index date, the diagnosis most proximate to or on the index date will be used to categorize the participant as having UC or CD.\n\nExclusion Criteria:\n\nParticipants with any of the following will be excluded from the analysis:\n\n* Any evidence of AMT utilization during the Baseline Period.\n* Participants with at least 2 ICD-10-CM codes for rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, hidradenitis suppurativa, juvenile idiopathic arthritis, non-infectious uveitis, or psoriatic arthritis during the Baseline Period.\n* Participants with 2 or more ICD-10-CM codes for non-dermatologic malignancy during the Baseline Period.",{"count":365,"type":21},23900,"More older people (more than 65 years of age) around the world are getting Ulcerative Colitis (UC) or Crohn's Disease (CD). This is happening because people are living longer and because more people overall are developing UC or CD. Medicines that treat UC\u002FCD, however, might make it easier for older adults to get infections.\n\nThe main aim of this study is to learn if there is a difference in the number and type of infections in older people when treated with either ENTYVIO or other advance medicines (TNF-alpha inhibitors or ustekinumab) that reduce swelling and pain by blocking a chemical in the body (called TNF-alpha).\n\nThe study will include people aged 65 years and older UC or CD who used either ENTYVIO with ustekinumab or a TNF-alpha inhibitor between 2016 and 2025.\n\nData will be collected from existing Medicare databases.",[27,26],"2026-06-19",{"date":370,"type":36},"2026-06-23",{"date":201,"type":21},{"date":373,"type":21},"2026-12-15",{"name":205,"class":69},{"id":376,"slug":377,"hasResults":12,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":56,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":397},"100588108","phase-3-mirikizumab-and-tirzepatide-administered-in-adult-participants-with-moderately-to-severely-active-crohns-disease-and-obesity-or-overweight-100588108","NCT06937099","Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight","A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight","COMMIT-CD","Inclusion Criteria:\n\n* Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD\n* Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg\u002Fm²), or overweight (BMI ≥27 kg\u002Fm2 to \\\u003C30 kg\u002Fm²) and in the presence of at least 1 weight-related comorbid conditions:\n\n  * hypertension\n  * Type 2 diabetes mellitus (T2DM)\n  * dyslipidemia\n  * obstructive sleep apnea, or\n  * cardiovascular disease.\n* Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.\n* Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.\n* Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.\n* Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy\n\nExclusion Criteria:\n\n* Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.\n* Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.\n* Currently have or are suspected to have an abscess.\n* Have a stoma, ileoanal pouch, or ostomy.\n* Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.\n* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.\n* Have a history of severe hypoglycemia and\u002For hypoglycemia unawareness within the 6 months prior to screening.\n* Have had more than 5% body weight change in the past 3 months\n* Have a current or recent acute, active infection.","70 Years",{"count":385,"type":21},290,[58],"The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.\n\nThe maximum duration of this study is up to 61 weeks.",[26,389],"Obesity or Overweight",{"date":370,"type":36},{"date":392,"type":36},"2025-06-26",{"date":394,"type":21},"2028-05",{"name":396,"class":69},"Eli Lilly and Company",186,{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":404,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":406,"targetDuration":4,"studyType":56,"phases":408,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":425},"100533520","phase-2-a-phase-2-study-to-evaluate-morf-057-in-adults-with-moderately-to-severely-active-crohns-disease-100533520","NCT06226883","A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","GARNET","Key Inclusion Criteria:\n\n* Has signs\u002Fsymptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and\u002For an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and\u002For advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and\u002For more than 3 resections, and\u002For has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and\u002For a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease",{"count":407,"type":21},385,[82],"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).",[411,26],"Inflammatory Bowel Diseases",[413,414,415,416,417,404],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":370,"type":36},{"date":420,"type":36},"2024-07-18",{"date":422,"type":21},"2030-06",{"name":424,"class":69},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",226,{"id":427,"slug":428,"hasResults":12,"nctId":429,"briefTitle":430,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":16,"minAge":341,"maxAge":434,"enrollmentInfo":435,"targetDuration":4,"studyType":56,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"100427330","phase-3-a-master-protocol-amaz-a-study-of-mirikizumab-ly3074828-in-pediatric-participants-with-ulcerative-colitis-or-crohns-disease-shine-on-100427330","NCT04844606","A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)","A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease","SHINE-ON","Inclusion Criteria:\n\n* Participants from originating studies (I6T-MC-AMBA \\[NCT05784246\\], I6T-MC-AMBU \\[NCT04004611\\], I6T-MC-AMAM \\[NCT03926130\\]) , I6T-MC-AMAY \\[NCT05509777\\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab\n* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.\n* Female participants must agree to contraception requirements.\n\nExclusion Criteria:\n\n* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.\n* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.\n* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.\n* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.\n* Participants must not have adenomatous polyps that have not been removed.\n* Participants must not be pregnant or breastfeeding.","19 Years",{"count":436,"type":21},150,[58],"The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.",[27,440,411,26],"Ulcerative Colitis Chronic",[442,443,444,445],"Pediatric Ulcerative Colitis","Pediatric Crohn's Disease","Pediatric UC","Pediatric CD",{"date":370,"type":36},{"date":448,"type":36},"2021-05-26",{"date":450,"type":21},"2030-12",{"name":396,"class":69},68,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":461,"targetDuration":4,"studyType":56,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":472,"locationsCount":149},"100607160","phase-3-a-maintenance-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-crohns-disease-100607160","NCT07184944","A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","A Multicenter, Multinational, Randomized, Double-blind, Placebo-controlled Phase 3, Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease","STARSCAPE-2","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \\\u003C18 years of age who meet the definition of Tanner stage 5 for development)\n* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of STARSCAPE-1\n* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study\n\nExclusion Criteria:\n\n* Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator\n* Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial",{"count":462,"type":21},751,[58],"This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD). Study details include:\n\nThe study duration may be up to 286 weeks including:\n\n* 40-week Pivotal Maintenance Sub-Study\n* 240-week Open-Label Extension (OLE) Sub-Study\n* 45-day Follow-Up visit\n\nNote: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.\n\nThe treatment duration may be up to 280 weeks including:\n\n* 40 weeks in the Pivotal Maintenance Sub-Study\n* 240 weeks in OLE Sub-Study\n\nThe total number of on-site visits will be up to 43: - 21 visits in the Pivotal Maintenance Sub-Study - 22 visits in the OLE Sub-Study",[26],"2026-06-18",{"date":305,"type":36},{"date":469,"type":36},"2026-01-22",{"date":471,"type":21},"2034-03-20",{"name":184,"class":69},{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":16,"minAge":341,"maxAge":342,"enrollmentInfo":480,"targetDuration":4,"studyType":56,"phases":482,"briefSummary":483,"conditions":484,"keywords":485,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":487,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":493},"100547216","phase-3-a-long-term-extension-study-of-vedolizumab-in-children-and-teenagers-with-ulcerative-colitis-uc-or-crohns-disease-cd-100547216","NCT06405087","A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)","A Phase 3b Extension Study to Evaluate the Long-term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease","Inclusion Criteria for Treatment Cohort 1. Has completed Week 34 of Study VedolizumabSC-3003 (NCT06100289) and achieved clinical response at Week 34 and was corticosteroid-free for at least the last 4 weeks (Week 30 to Week 34). Clinical response for participants with UC is defined as a reduction of partial Mayo score of \\>=2 points and \\>= 25 percentage (%) from baseline (from VedolizumabSC-3003 \\[NCT06100289\\]), including a \\>=1-point decrease in the Mayo stool frequency subscore and a \\>=1-point reduction in the rectal bleeding subscore or absolute rectal bleeding subscore of less than or equal to (\\\u003C=) 1 point. Clinical response for participants with CD is defined as a pediatric Crohn's disease activity index (PCDAI) \\\u003C=30 with a reduction in the PCDAI of \\>=15 points from baseline (from VedolizumabSC-3003 \\[NCT06100289\\]).\n\nInclusion Criteria for Observational Cohort\n\n1\\. Has received at least 1 dose of vedolizumab during Study VedolizumabSC-3003 (NCT06100289) and early terminated OR completed the Week 34 clinic visit of Study VedolizumabSC-3003 (NCT06100289) but was not eligible to enroll in the treatment cohort of this study.\n\nExclusion Criteria for Treatment Cohort\n\n1. Has hypersensitivity or allergies to vedolizumab or any of its excipients.\n2. The participant currently requires major surgical intervention for UC or CD (example, bowel resection), or is anticipated to require major surgical intervention for UC or CD during the study.",{"count":481,"type":21},70,[58],"The main aim of this study is to learn about medical problems (adverse events) if vedolizumab subcutaneously (SC) is given to a child or teenager with UC or CD for a long time. Other aims are to understand if the long time use of vedolizumab SC has an impact on the time period until hospital visits because of bowel swelling (inflammation) are needed and has an impact on the quality of life of children and teenagers who received vedolizumab SC.\n\nIn this study, participants who responded well to the treatment with vedolizumab SC in the parent study (VedolizumabSC-3003 \\[NCT06100289\\]) will continue to be treated with vedolizumab SC. Participants who did not respond well to the treatment with vedolizumab SC in the parent study or who received corticosteroids in the last 4 weeks of the parent study will not receive vedolizumab SC in this study but will be followed for up to 2 years after the last treatment with vedolizumab SC in the parent study.\n\nDuring the study, participants will visit their study clinic several times.",[27,26],[486],"Drug Therapy",{"date":305,"type":36},{"date":489,"type":36},"2025-10-27",{"date":491,"type":21},"2030-08-12",{"name":205,"class":69},54,{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":383,"enrollmentInfo":501,"targetDuration":4,"studyType":56,"phases":503,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":509,"leadSponsor":511,"locationsCount":513},"100644329","phase-4-treatment-of-chinese-adult-subjects-with-moderate-to-severe-crohns-disease-with-tabellvi-100644329","NCT07663526","Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®","A Multicenter, Single-Arm Study to Evaluate the Effectiveness and Safety of Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease in the Real-World Setting","Inclusion Criteria:\n\n* The subject must sign the informed consent form.\n* Aged 18 to 70 years inclusive, no gender restriction.\n* Subjects with definite diagnosis of Crohn's disease in accordance with Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023), presenting moderate to severe active Crohn's disease with inadequate response, intolerance or contraindication to adequate glucocorticoid and\u002For immunosuppressant therapy.\n* Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment.\n* Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator.\n\nExclusion Criteria:\n\n* Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician.\n* Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period.\n* Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection.\n* Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis).\n* Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose.\n* Subjects with active tuberculosis infection; or latent tuberculosis infection without adequate treatment; subjects infected with human immunodeficiency virus (HIV); subjects positive for hepatitis C virus antibody (HCV Ab) indicating previous or current infection; subjects positive for hepatitis B surface antigen (HBsAg), or positive for total hepatitis B core antibody (total Hepatitis B core Ab) with positive hepatitis B virus (HBV)-DNA polymerase chain reaction test result.\n* Subjects with syphilis infection requiring treatment.\n* Subjects with moderate to severe heart failure (NYHA Class III\u002FIV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study.\n* Subjects with current evidence of dysplasia or a history of malignant tumors (including lymphoma and leukemia), except cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized cervical carcinoma in situ.\n* Subjects with a history of demyelinating diseases (including myelitis), or neurological symptoms suggestive of demyelinating diseases.\n* Subjects who have undergone intestinal resection within the past 6 months, or plan to undergo intestinal resection at any time in the future.\n* Subjects receiving total parenteral nutrition (TPN), or planning to receive TPN at any time during the study period.\n* Subjects with an ostomy or an ileal pouch-anal anastomosis (IPAA) pouch.\n* Subjects with internal or external fistulas, except perianal fistulas without abscess.\n* Subjects with known symptomatic obstructive intestinal strictures.\n* Subjects diagnosed with ulcerative colitis or indeterminate colitis.\n* Subjects with any of the following abnormal laboratory or other examination results during the screening period: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 1.5 times the upper limit of the reference range; white blood cell count \\\u003C 3.0×10⁹\u002FL; electrocardiogram (ECG) with clinically significant abnormalities; total bilirubin ≥3 mg\u002FdL (isolated elevated indirect bilirubin caused by Gilbert's syndrome excluded); serum creatinine \\>1.6 mg\u002FdL.\n* Subjects with other clinically significant abnormal laboratory test results (other than those listed above) identified by the investigator during screening.\n* Subjects who have received other tumor necrosis factor-alpha (TNF-α) inhibitor therapy within 12 weeks before receiving the first dose of Tabellvi® Adalimumab Injection.\n* Subjects currently participating in another clinical study.\n* Subjects deemed unsuitable for participation in this trial by the investigator.",{"count":502,"type":21},50,[217],"This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious ADRs, as well as the proportion of subjects achieving clinical remission (CDAI score \\\u003C 150) at Week 26.",[26],"2026-06-17",{"date":370,"type":36},{"date":308,"type":21},{"date":510,"type":21},"2029-03",{"name":512,"class":69},"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.",7,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":521,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":522,"targetDuration":4,"studyType":56,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":44},"100555300","digital-mind-body-intervention-among-black-and-hispanic-patients-living-with-inflammatory-bowel-disease-100555300","NCT06510296","Digital Mind Body Intervention Among Black and Hispanic Patients Living With Inflammatory Bowel Disease","DMBI","Inclusion Criteria:\n\n* age ≥ 18 years\n* self-identify as Black\u002FAfrican American and\u002For Hispanic\u002FLatino(a\u002Fx)\n* diagnosed with Crohn's disease or ulcerative colitis\n* ability to provide informed consent in English\n* elevated psychological distress: at least one T-score within 2.5 standard deviations above the mean -- NIH Toolbox Perceived Stress Scale or in the domains of either Anxiety or Depression on the NIH PROMIS-29.\n\nExclusion Criteria:\n\n* Anxiety, depression, or perceived stress T-scores above 2.5 standard deviations above the mean.\n* Current suicidality, past suicide attempt, or psychiatric hospitalization.",true,{"count":523,"type":21},40,[296],"The bidirectional effects between psychological distress and inflammatory bowel disease (IBD) activity mean that not only does increased IBD activity trigger psychological distress, but psychological distress triggers increased IBD activity (i.e., gut-brain interaction). Comorbid psychological distress is linked to increased health resource utilization and poor health-related quality of life (HRQoL). This has prompted calls for integrating psychological care into IBD practice with restoration of quality of life as a clinical target of IBD management alongside endoscopic healing. The IBD Social Cognitive Model (IBD SCM) posits that patient psycho-behavioral modifiers contribute to IBD outcomes and not disease modifiers alone. While a co-localized gastro-psychologist in an IBD medical home is an emerging mode of delivering psycho-behavioral care among people living with IBD, access and scalability of this form of support is not yet widespread, particularly in resource-limited settings. Though many people with IBD have significant psychological distress, mental health care is underutilized with cost cited as a barrier.\n\nThe emergence of digital interventions in clinical practice presents an opportunity to address access, scalability, and cost barriers. However, current testing of digital interventions to address gut-brain interactions (digital mind-body intervention, DMBI) among people with IBD involves mostly women with high educational attainment who have full time employment and do not receive social service benefits. Individuals with limited resources and those from racial and ethnic minority groups (e.g. Black, Hispanic) often have socioecological factors, such as healthcare access and mental health stigma, that impede their use of psycho-behavioral resources. DMBI development informed by participatory research approaches are, therefore, critical to facilitate equitable engagement and utilization. Beneficial effects of psycho-behavioral treatment among people with IBD are strongest for those who have psychological distress and for acceptance, mindfulness, and values-based approaches.\n\nAlthough high quality evidence demonstrates psychological improvement with DMBI in IBD, feasibility and acceptability of applying DMBI to IBD patients from racial and ethnic minority groups is lacking.",[26,27,411],"2026-06-16",{"date":506,"type":36},{"date":530,"type":21},"2027-07",{"date":532,"type":21},"2028-09",{"name":534,"class":139},"Montefiore Medical Center",{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":543,"targetDuration":4,"studyType":56,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":556},"100565088","phase-2-a-study-to-investigate-efficacy-and-safety-of-sar441566-in-patients-with-crohns-disease-100565088","NCT06637631","A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.","A Phase 2, Multinational, Multicenter, Randomized, Doubleblind, Placebocontrolled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate to Severe Crohn's Disease.","SPECIFI-CD","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female participants aged 18 to 75 years at the time of signing the ICF\n2. Confirmed diagnosis of CD for at least 3 months prior to Baseline\n3. Confirmed diagnosis of moderate to severe CD as assessed by:\n\n   * Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader\n   * stool frequency (SF), abdominal pain (AP) score\n4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies\n5. On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)\n6. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Participants with active UC, indeterminate colitis or short bowel syndrome\n2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement\n3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture\u002Fstenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \\> 3 bowel resections\n4. Participants with stool sample positive for infectious pathogens\n5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines\n6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and\u002For positive Hepatitis C antibody (HCV) at the Screening Visit\n7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex\n8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening\n9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening\n10. History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit\n11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral\u002Fintramuscular anti-infectives within 14 days prior to the screening visit\n12. Participants requiring or receiving any parental nutrition and\u002For exclusive enteral nutrition\n13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening\n14. Participants who received fecal microbial transplantation within 30 days prior to screening\n15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)\n16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period\n17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening\n18. Screening laboratory and other analyses show abnormal results\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",{"count":544,"type":21},260,[82],"This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD.\n\nThis study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance.\n\nAdditionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.",[26],"2026-06-11",{"date":550,"type":36},"2026-06-12",{"date":552,"type":36},"2024-12-10",{"date":554,"type":21},"2029-05-23",{"name":184,"class":69},139,{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":563,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":16,"minAge":565,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":56,"phases":568,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":583},"100567065","phase-3-a-long-term-extension-lte-study-of-guselkumab-in-pediatric-participants-100567065","NCT06663332","A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants","CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis","TRILOGY","Inclusion Criteria:\n\n* Must have completed the dosing planned in the primary pediatric guselkumab study\n* Must have received benefit from continued guselkumab therapy in the opinion of the investigator\n* Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure\n* Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.\n\nExclusion Criteria:\n\n* Participant is greater than or equal to (\\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication\n* Participant is \\\u003C18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication\n* Are pregnant, nursing, or planning pregnancy or fathering a child\n* Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention\n* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments","3 Years",{"count":567,"type":21},196,[58],"The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).",[571,572,573,574],"Crohns Disease","Colitis, Ulcerative","Arthritis, Psoriatic","Arthritis, Juvenile","2026-06-09",{"date":548,"type":36},{"date":578,"type":36},"2024-10-29",{"date":580,"type":21},"2032-02-25",{"name":582,"class":69},"Janssen Research & Development, LLC",47]