[{"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,87,0,25,[9,45,72,94,123,148,173,197,219,239,261,286,313,340,361,388,411,429,459,485,512,532,562,583,603],{"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},"100641419","longitudinal-immunophenotyping-of-patients-with-inflammatory-bowel-disease-100641419",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: immediate 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","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":21},"2026-08-26",{"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":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"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":55,"type":21},290,"INTERVENTIONAL",[58],"PHASE3","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.",[26,61],"Obesity or Overweight","RECRUITING",{"date":35,"type":36},{"date":65,"type":36},"2025-06-26",{"date":67,"type":21},"2028-05",{"name":69,"class":70},"Eli Lilly and Company","INDUSTRY",184,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":56,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100549191","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-tulisokibart-mk-7240-in-participants-with-moderate-to-severe-crohns-disease-mk-7240-008-100549191","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 Crohn's disease (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 CD.\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-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).","16 Years","80 Years",{"count":82,"type":21},1200,[58],"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],{"date":35,"type":36},{"date":88,"type":36},"2024-06-05",{"date":90,"type":21},"2029-11-12",{"name":92,"class":70},"Merck Sharp & Dohme LLC",499,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":102,"targetDuration":4,"studyType":56,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"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":103,"type":21},385,[105],"PHASE2","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).",[108,26],"Inflammatory Bowel Diseases",[110,111,112,113,114,100],"Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin",{"date":35,"type":36},{"date":117,"type":36},"2024-07-18",{"date":119,"type":21},"2030-06",{"name":121,"class":70},"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)",225,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":56,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":44},"100537186","phase-3-testing-the-role-of-anti-fungal-therapy-in-improving-the-response-to-therapies-for-crohns-disease-100537186","NCT06274554","Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease","A Prospective, Randomized, Placebo-controlled Trial of Fluconazole in Combination With IL-23 Therapy Versus IL-23 Therapy Alone for the Treatment of Crohn's Disease","FUN-CD","Inclusion Criteria:\n\n1. Patients at least 18 years old\n2. Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450\n\nExclusion Criteria:\n\n1. Antifungal usage within one month prior to initiation of blinded fluconazole usage\n2. Known allergy to fluconazole\n3. Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \\>3X upper limit of normal (ULN), and\u002For bilirubin levels \\>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline\n4. Patients taking any medications judged by clinical provider to interact with fluconazole and are known contraindications (refer to section 2.2) and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc\n5. Pregnant or lactating women\n6. Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician\n7. Patient with symptomatic stricturing\n8. Patient with pouchitis or an ostomy\n9. Patients with known, active fungal infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and\u002For prolonged courses of fluconazole or other therapies.\n10. Patients with hypokalemia, or advanced cardiac failure\n11. Patients with renal insufficiency",{"count":132,"type":21},120,[58],"The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease.\n\nThe main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.",[26,108],[137,138],"Fluconazole","IL-23","2026-08-18",{"date":33,"type":36},{"date":142,"type":36},"2024-10-04",{"date":144,"type":21},"2029-12",{"name":146,"class":147},"Weill Medical College of Cornell University","OTHER",{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":56,"phases":158,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"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":157,"type":21},35,[159,105],"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],[163,164],"Reduce Symptoms of Crohn's Disease","HDAC Inhibitors","2026-08-15",{"date":139,"type":36},{"date":168,"type":36},"2017-10-30",{"date":170,"type":21},"2035-06-30",{"name":172,"class":43},"National Institute of Allergy and Infectious Diseases (NIAID)",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":181,"targetDuration":4,"studyType":56,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"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":182,"type":21},400,[184],"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],"2026-08-13",{"date":189,"type":36},"2026-08-14",{"date":191,"type":36},"2025-03-27",{"date":193,"type":21},"2028-06-01",{"name":195,"class":70},"Takeda",101,{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":204,"targetDuration":4,"studyType":56,"phases":205,"briefSummary":206,"conditions":207,"keywords":208,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":218},"100519607","phase-4-a-study-of-vedolizumab-intravenous-iv-and-adalimumab-or-vedolizumab-and-ustekinumab-in-adults-with-crohns-disease-100519607","NCT06045754","A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease","An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV\u002FSC in Moderate to Severe Crohn's Disease (CD)","Inclusion Criteria:\n\nPart A:\n\n1. Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.\n2. Has moderately to severely active CD at Screening, defined as an SES-CD \\>=6 (\\>=4 if isolated ileal disease).\n3. Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:\n\n   1. Inadequate response after completing the full induction regimen;\n   2. Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or\n   3. Intolerance (a significant adverse event that precluded further use, including but not limited to serious infection including opportunistic infections, malignancy, infusion-related and hypersensitivity reactions including anaphylaxis, and liver injury).\n\n   Note: Participants with an inadequate response to \\>2 classes of advanced therapies or \\>1 agent in the same class are not eligible. Participants who discontinued a third class of advanced therapy for reasons other than inadequate response may be eligible after discussion with the Medical Monitor.\n\n   Part B:\n4. In the investigator's opinion, the participant exhibits a therapeutic benefit at Week 26.\n\nExclusion Criteria:\n\n1. CDAI score \\> 450.\n2. A current diagnosis of ulcerative colitis or indeterminate colitis.\n3. Clinical evidence of an abdominal abscess.\n4. Known fistula (other than perianal fistula) or phlegmon.\n5. Known perianal fistula with abscess.\n6. Ileostomy, colostomy, or severe, or symptomatic stenosis of the intestine.\n7. Previous extensive bowel resection with 2 entire segments missing, of the following: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n8. Short bowel syndrome.\n9. Any planned surgical intervention for CD, except for seton placement for perianal fistula without abscess.\n10. History or evidence of adenomatous colonic polyps that have not been removed.\n11. History or evidence of colonic mucosal dysplasia.\n12. Intolerance or contraindication to ileocolonoscopy.\n13. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency infection).\n14. Active or latent tuberculosis (TB), regardless of treatment history.\n15. A positive test for hepatitis B virus (HBV) as defined by the presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) test.\n16. A positive test for hepatitis C virus (HCV), as defined by a positive hepatitis C virus antibody (HCVAb) test and detectable HCV ribonucleic acid (RNA).\n17. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \\[AMG 181\\], anti- mucosal addressin cell adhesion molecule-1 \\[MAdCAM-1\\] antibodies, or rituximab) for the treatment of CD.\n18. History of or symptoms of progressive multifocal leukoencephalopathy (PML) in the investigator's opinion. If a participant has symptoms consistent with PML, a PML checklist must be completed and submitted to the PML independent adjudication committee. If the PML IAC deems the participant to have PML, the participant is ineligible.",{"count":20,"type":21},[184],"The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment.\n\nThe study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A.\n\nEach participant will be followed up for at least 26 weeks after the last dose of treatment.",[26],[209],"Drug Therapy","2026-08-11",{"date":212,"type":36},"2026-08-12",{"date":214,"type":36},"2024-04-18",{"date":216,"type":21},"2027-06-28",{"name":195,"class":70},48,{"id":220,"slug":221,"hasResults":12,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":80,"enrollmentInfo":227,"targetDuration":4,"studyType":56,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":237,"locationsCount":4},"100650956","a-phase-2-study-of-sl-325-in-crohns-disease-patients-100650956","NCT07753850","A Study of SL-325 in Crohn's Disease Patients","A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SL-325 in Participants With Moderately to Severely Active Crohn's Disease","RECEPTIVE-CD1","Key Inclusion Criteria:\n\n* A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening\n* Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450\n* SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following Crohn's disease treatments: corticosteroids, immunomodulators, or an approved anti-tumor necrosis factor (TNF), anti-integrin, anti-interleukin (IL)-12\u002F23, anti-interleukin (IL)-23p19, or Janus kinase inhibitor (JAK)\n\nKey Exclusion Criteria:\n\n* Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD\n* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement\n* Presence or suspicion of any of the following CD complications: intra-abdominal or perianal abscess; symptomatic stricture or colonic stenosis not passable in ileocolonoscopy, fistula, except for perianal fistula; active toxic megacolon or fulminant colitis; short bowel syndrome\n* Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of \\> 2 segments\n* Diagnosis of primary sclerosing cholangitis\n* Has a stoma, ileostomy, or colostomy.\n* Has prior or current gastrointestinal dysplasia, other than a completely removed low-grade dysplastic lesion.\n* Has active tuberculosis (TB) or inadequately treated latent tuberculosis (LTBI)\n* Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component",{"count":228,"type":21},232,[105],"The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease.\n\nThe study consists of a screening period of up to 6 weeks, a 12-week induction period, 38-week maintenance period, 52-week long-term extension period, and a 10-week follow-up period.",[26],"2026-08-10",{"date":212,"type":36},{"date":235,"type":21},"2026-10",{"date":119,"type":21},{"name":238,"class":70},"Shattuck Labs, Inc.",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":246,"targetDuration":4,"studyType":56,"phases":248,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100555477","behavioral-therapy-for-crohns-disease-100555477","NCT06512597","Behavioral Therapy for Crohn's Disease","Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial)","Inclusion Criteria:\n\n* Adults (18-65 years old) of any sex, gender, and racial\u002Fethnic background with an endoscopically and histologically confirmed CD diagnosis will be eligible.\n* Participants must have active CD symptoms as defined by a Crohn's Disease Activity Index (CDAI) of at least 220 and\n* Active endoscopic inflammation defined as a Simple Endoscopic Score for CD (SES-CD) \\> 6 (or ≥4 for isolated ileal disease) on most recent colonoscopy OR active disease on imaging study OR elevated calprotectin\u002FCRP levels\n* Must be planning to start an anti-TNF (adalimumab, certolizumab, or infliximab) or anti-IL-23 (risankizumab, guselkumab, mirikizumab) within the prior 2 weeks or in the next 6 weeks.\n* Participants will need to live in one of Dr Keefer's 30+ PSYPACT licensed states.\n\nExclusion Criteria:\n\n* Endoscopically inactive Crohn's disease at baseline.\n* Unable to consent to participation.\n* Pregnant or planning to become pregnant in next 12 months.\n* Severe psychiatric symptoms.\n* Surgical history for CD.",{"count":247,"type":21},170,[249],"NA","People living with Crohn's disease (CD) experience psychological and emotional symptoms, in addition to known chronic and disabling physical symptoms, which prevent them from living their life to the fullest (flourishing). Depression and anxiety are experienced by 30% of people living with CD and 60% of inflammatory bowel disease (IBD) patients continue to report chronic pain, stress, sleeplessness, and fatigue, even when they are \"objectively\" in remission. Psychological stress has been endorsed by 70% of patients with IBD as a key trigger for disease activity which is not surprising given the significance of the gut-brain-microbiome axis, the close communication between the enteric and autonomic nervous systems, and the role of the hypothalamic-pituitary axis and its neuroendocrine and immune functions in the expression of GI symptoms. Interestingly, up to 85% of patients with CD also endorse the positive impact of effective coping skills on disease course. The PI's prior work has suggested that early provision of effective coping strategies, offered at the time of diagnosis or more precisely, immediately prior to biologic medication initiation, could potentially result in faster healing and improved well-being, likely through the combination of 1) physiological mitigation of the stress response and optimization of the gut-brain-microbiome axis; and 2) promotion of effective coping and disease self-management behaviors that promote psychological flourishing despite disease. Unfortunately, to date, early effective psychosocial care has been limited by concerns over reimbursement for psychological services, access to qualified IBD mental health professionals, and the lack of a standardized methodology focused on the brain-gut stress response and how to assess, monitor, communicate and maintain tight control over both physical and emotional well-being. CATHARSIS is a rigorous, placebo-controlled, randomized controlled trial of coping strategies plus medication for 170 people living with Crohn's for less than 5 years who are about to start a new biologic medication due to active disease. Outcomes include improvements in emotional well-being as well as clinical and endoscopic remission over a 12-month period. The overall goal of the study is to demonstrate that it is essential to combine biologic therapy and psychosocial care to ensure optimal and long-term positive outcomes in CD.",[26],"2026-08-09",{"date":212,"type":36},{"date":255,"type":36},"2024-11-01",{"date":257,"type":21},"2028-07-30",{"name":259,"class":147},"Icahn School of Medicine at Mount Sinai",2,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":16,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":56,"phases":273,"briefSummary":274,"conditions":275,"keywords":276,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100478423","phase-3-a-study-of-mirikizumab-ly3074828-in-pediatric-participants-with-crohns-disease-100478423","NCT05509777","A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease","A Phase 3, Multicenter, Randomized Clinical Study to Evaluate Mirikizumab in Pediatric Crohn's Disease","AMAY","Inclusion Criteria:\n\n* Participants must have a diagnosis of CD or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.\n* Participants have moderately to severely active CD (as defined by a baseline PCDAI score ≥30).\n* Participants must have endoscopy with evidence of active CD defined as SES-CD score ≥6 (or ≥4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0.\n* Participants must have a documented history of inadequate response, loss of response or intolerance to at least one medication used to treat CD, which may include immunomodulators, oral or IV corticosteroids, a biologic therapy or a JAK inhibitor.\n\nExclusion Criteria:\n\n* Participants must not have complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestations that might be anticipated to require surgery.\n* Participants must not have an abscess.\n* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline.","2 Years","17 Years",{"count":272,"type":21},90,[58],"Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease.\n\nStudy periods for the intervention-specific appendix (ISA) will be as follows:\n\n* A 12-week induction period\n* A maintenance period from Week 12 to Week 52, and\n* A safety follow-up period up to 16 weeks.\n\nThe study will last about 74 weeks and may include up to 19 visits.",[26],[25],"2026-08-06",{"date":279,"type":36},"2026-08-07",{"date":281,"type":36},"2024-03-13",{"date":283,"type":21},"2028-04",{"name":69,"class":70},81,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":16,"minAge":269,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":56,"phases":297,"briefSummary":298,"conditions":299,"keywords":301,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"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":296,"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.",[27,300,108,26],"Ulcerative Colitis Chronic",[302,303,304,305],"Pediatric Ulcerative Colitis","Pediatric Crohn's Disease","Pediatric UC","Pediatric CD",{"date":279,"type":36},{"date":308,"type":36},"2021-05-26",{"date":310,"type":21},"2030-12",{"name":69,"class":70},68,{"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":62,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":44},"100631732","exclusive-enteral-nutrition-therapy-for-active-and-complicated-crohns-disease-100631732","NCT07504510","Exclusive Enteral Nutrition Therapy for Active and Complicated Crohn's Disease","Effectiveness and Safety of Exclusive Enteral Nutrition in Adults With Active and Complicated Crohn's Disease: A Single-Center Prospective Cohort Study","EEN-CD","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Diagnosis of Crohn's disease established on the basis of overall clinical assessment, including compatible clinical history and standard endoscopic, histologic, and\u002For radiologic findings, as determined by the treating physician. Histologic confirmation at baseline is not required if endoscopy or biopsy is not feasible or clinically inappropriate because of severe disease, poor nutritional status, or intra-abdominal abscess\u002Fsepsis.\n3. Active Crohn's disease at baseline, as determined by the treating physician.\n4. Willingness to initiate and receive exclusive enteral nutrition (EEN) as the sole induction therapy as part of physician-directed routine care.\n5. Presence of malnutrition or nutritional risk and clinical indication for EEN.\n6. Patients with intestinal complications, including enteric fistula, intestinal stricture, and\u002For intra-abdominal abscess, are eligible if considered appropriate for EEN-based management by the treating physician.\n7. Ability and willingness to provide written informed consent and to comply with study assessments and follow-up for 12 weeks.\n\nOptional clarifying note:\n\nIn participants without histologic confirmation at baseline, the diagnosis may be further confirmed during follow-up when clinically feasible, including by endoscopic biopsy or surgical pathology.\n\nExclusion Criteria\n\n1. Any absolute contraindication to enteral nutrition, including but not limited to gastrointestinal perforation, uncontrolled gastrointestinal bleeding, severe hemodynamic instability\u002Fshock, or other conditions where enteral feeding is not clinically appropriate.\n2. Immediate need for emergency surgery at baseline.\n3. Inability or unwillingness to receive EEN as the sole induction therapy at baseline.\n4. Any condition that, in the investigator's opinion, would make participation unsafe or would substantially interfere with study assessments or follow-up.",{"count":322,"type":21},300,"The goal of this observational study is to evaluate the effectiveness and safety of exclusive enteral nutrition (EEN) in adults with active Crohn's disease (CD), particularly in patients with complicated disease such as stricturing disease, enteric fistula, and intra-abdominal abscess. The main questions it aims to answer are:\n\n* What is the clinical remission rate at Week 12 in adults with active CD treated with EEN?\n* How does EEN affect clinical response, endoscopic outcomes, inflammatory markers, nutritional status, BMI, and safety during follow-up?\n\nParticipants will:\n\n* start EEN at baseline and be followed through Week 12;\n* receive EEN as the main treatment approach during the study period;\n* complete clinical, laboratory, nutritional, and safety assessments at prespecified follow-up visits;\n* undergo endoscopic assessment when endoscopy is performed as part of routine care; and\n* if clinically indicated, some participants with large intra-abdominal abscesses may receive percutaneous drainage and necessary antibiotic treatment.",[26],[326,327,328,329,330],"exclusive enteral nutrition","active Crohn's disease","enteric fistula","intestinal stricture","intra-abdominal abscess","2026-08-03",{"date":333,"type":36},"2026-08-04",{"date":335,"type":36},"2020-06-01",{"date":337,"type":21},"2026-12-31",{"name":339,"class":147},"Sixth Affiliated Hospital, Sun Yat-sen University",{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":16,"minAge":269,"maxAge":270,"enrollmentInfo":347,"targetDuration":4,"studyType":56,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100523790","phase-3-a-study-of-vedolizumab-in-children-and-teenagers-with-ulcerative-colitis-or-crohns-disease-100523790","NCT06100289","A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease","An Open-Label, Phase 3 Study to Evaluate the Pharmacokinetics, Safety, and Immunogenicity of Vedolizumab Subcutaneous in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy","Inclusion Criteria:\n\n1. The participant weighs ≥10 kg at the time of screening and enrollment into the study.\n2. Participants with UC or CD diagnosed at least 1 month before screening. Participants with moderately to severely active disease defined as:\n\n   * Participants with UC: a modified Mayo score of 5 to 9 (sum of Mayo endoscopic subscore, stool frequency subscore, and rectal bleeding subscore) with a Mayo endoscopic subscore of ≥2 (with the presence of mucosal friability excluding an endoscopic subscore of 1 and mandating a score of at least 2). (The results of screening endoscopy should be applied.)\n   * Participants with CD: a pediatric Crohn's disease activity index (PCDAI) \\>30 and a simple endoscopic score for Crohn's disease (SES-CD) \\>6 (or an SES-CD ≥4 if disease is confined to terminal ileum) at screening endoscopy.\n3. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (for example, azathioprine \\[AZA\\], 6-mercaptopurine \\[6-MP\\], methotrexate \\[MTX\\]), and\u002For tumor necrosis factor (TNF)-α antagonist therapy (for example, infliximab, adalimumab).\n4. Participants with evidence of UC extending proximal to the rectum (that is, not limited to proctitis), at a minimum.\n5. Participants with extensive colitis or pancolitis of \\>8 years' duration or left-sided colitis of \\>12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening.\n6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.\n\nExclusion Criteria:\n\n1. Participants who have had previous exposure to approved or investigational anti-integrins, including but not limited to, natalizumab, efalizumab, etrolizumab, or abrilumab (AMG 181); or mucosal addressin cell adhesion molecule-1 (MAdCAM-1) antagonists (ontamalimab), or rituximab.\n2. Participants who have had prior exposure to vedolizumab.\n3. Participants with hypersensitivity or allergies to vedolizumab or any of its excipients.\n4. Participants with active cerebral\u002Fmeningeal disease, signs\u002Fsymptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders.\n5. The participant has received any live vaccinations within 30 days before first dose of study drug.\n6. Participants who currently require surgical intervention or are anticipated to require surgical intervention for UC or CD during this study.\n7. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or \\>3 small intestine resections.\n8. Participants with a current diagnosis of indeterminate colitis.\n9. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease (IBD).\n10. Participants with active or latent tuberculosis (TB).\n11. Participants with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Hepatitis B virus (HBV) immune subjects (that is, HBsAg negative and hepatitis B surface antibody \\[anti-HBs\\]-positive) may, however, be included.\n12. The participant has any identified congenital or acquired immunodeficiency (for example, common variable immunodeficiency, human immunodeficiency virus \\[HIV\\] infection, organ transplantation).\n13. Participants with positive stool studies for ova and\u002For parasites or stool culture at screening visit.\n14. Participants with positive Clostridioides difficile (C difficile) stool test at screening visit.",{"count":348,"type":21},70,[58],"The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin subcutaneously (SC).\n\nThe participants will be treated with vedolizumab for up to 34 weeks.\n\nDuring the study, participants will visit their study clinic several times.",[27,26],[209],"2026-07-31",{"date":331,"type":36},{"date":356,"type":36},"2025-01-22",{"date":358,"type":21},"2028-05-16",{"name":195,"class":70},54,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":16,"minAge":369,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":56,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":387},"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":371,"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).",[375,376,377,378],"Crohns Disease","Colitis, Ulcerative","Arthritis, Psoriatic","Arthritis, Juvenile","2026-07-30",{"date":353,"type":36},{"date":382,"type":36},"2024-10-29",{"date":384,"type":21},"2032-02-25",{"name":386,"class":70},"Janssen Research & Development, LLC",49,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":396,"conditions":397,"keywords":398,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":260},"100605945","protease-regulation-and-impact-of-sodium-as-mechanisms-of-inflammation-in-ibd-100605945","NCT07169123","Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD","PRISM-IBD","Inclusion Criteria:\n\n* 18 and 70 years of age\n* Crohn's disease diagnosis\n* Willing and able to sign written informed consent prior to study entry\n* Able to comply with the study procedures, in the opinion of the investigator\n\nExclusion Criteria:\n\n* Antibiotics, antibacterial agents, or probiotics, currently, or within the last 8 weeks\n* Alcohol or drug abuse\n* Pregnancy\n* Concurrent systemic disease and\u002For laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection",{"count":322,"type":21},"The study looks at how eating salt affects gut health in people with Crohn's disease. The aim of the study is to find out whether eating more salt increases the breakdown of proteins in the gut and if this makes inflammation and symptoms worse. By studying the link between salt, gut bacteria and inflammation, the study hopes to improve diet advice for people with Crohn's disease. This research may help find specific foods that affect the disease and lead to better, more personalized nutrition plans.",[375],[399,400,401,402],"sodium","Crohn's disease","proteases","diet","2026-07-29",{"date":379,"type":36},{"date":406,"type":36},"2025-08-18",{"date":408,"type":21},"2029-09-01",{"name":410,"class":147},"McMaster University",{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":16,"minAge":155,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":426,"leadSponsor":428,"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":419,"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],"2026-07-24",{"date":424,"type":36},"2026-07-27",{"date":165,"type":21},{"date":427,"type":21},"2026-12-15",{"name":195,"class":70},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":436,"enrollmentInfo":437,"targetDuration":4,"studyType":56,"phases":439,"briefSummary":440,"conditions":441,"keywords":442,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":454,"leadSponsor":456,"locationsCount":458},"100645879","phase-2-study-of-advanced-therapies-for-the-treatment-of-adult-participants-with-moderately-to-severely-active-crohns-disease-or-ulcerative-colitis-100645879","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":438,"type":21},2000,[105],"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],[443,444,445,446,447,448,449],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","2026-07-07",{"date":452,"type":36},"2026-07-13",{"date":422,"type":21},{"date":455,"type":21},"2031-10",{"name":457,"class":70},"AbbVie",30,{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":436,"enrollmentInfo":466,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"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":467,"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],[443,471,472,473,474,475,476,477],"IL-23 inhibitor","TNF inhibitor","Bio-naive","Real-world study","Observational cohort","Clinical remission","Endoscopic remission",{"date":479,"type":36},"2026-07-09",{"date":481,"type":36},"2026-04-16",{"date":483,"type":21},"2028-08-31",{"name":339,"class":147},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":56,"phases":495,"briefSummary":496,"conditions":497,"keywords":499,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":44},"100646509","phase-4-stopping-ppi-therapy-in-inactive-ibd-100646509","NCT07691138","Stopping PPI Therapy in Inactive IBD","STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study","STOP-IT","Inclusion Criteria:\n\n* Aged 16 years or older.\n* An IBD diagnosis as defined through SNOMED codes in primary care databases \\[Appendix 5\\]\n* Taking a PPI regularly for \\>6 months prior to enrolment\n* Patient-confirmed compliance with PPI therapy (\\>75% of prescribed doses)\n* Able to give full, independent valid Informed consent\n* Stable disease as defined by no change in medication or IBD-related surgery for the last 3 months.\n\nExclusion Criteria:\n\n* Unable to participate fully in all aspects of the clinical trial.\n* Barrett's oesophagus\n* Peptic disease at a recent upper GI endoscopy\n* Zollinger-Ellison Syndrome\n* Eosinophilic oesophagitis\n* Chronic NSAID usage\n* Pulmonary fibrosis.\n* Declined consent to data sharing\n* History of dementia\n* Terminal illness\n* Present malignancy\n* Active history of mental illness\n* In a care home\n* Alcohol misuse\n* Illicit drug misuse",{"count":494,"type":21},80,[184],"To investigate the feasibility of proton pump inhibitor (PPI) withdrawal in inflammatory bowel disease (IBD); the data collected will provide valuable information to inform a future multi-centre randomised controlled trial.\n\nEvidence suggests that patients with IBD taking PPIs respond less well to medication and require hospital treatment more frequently than patients not taking PPIs. This may be due to changes in the gut microbiota associated with PPI use.\n\nA future definitive trial is planned to investigate clinical outcomes in patients who stop PPIs compared with those who continue PPIs, in order to determine the safety implications of PPI use in IBD. However, several uncertainties remain which require investigation before such a trial can be undertaken. It is currently unknown how many patients with IBD take PPIs, how many can successfully stop taking PPIs, how many would be willing to stop treatment, and how many would remain off treatment long term. In some cases, withdrawal of PPIs may result in a short-term increase in acid reflux symptoms. The willingness of patients to participate in such a study is also unknown. This study will be conducted in GP practices, a setting in which IBD trials have not previously been undertaken.\n\nThe study will recruit 80 participants with IBD aged 16 years and over who have been taking PPIs regularly for more than six months. Half of participants will be randomised to discontinue PPI therapy. Participants will be followed up for 12 months. The study will provide information regarding recruitment rates within GP practices, optimal methods for PPI withdrawal, and whether stopping PPIs affects IBD outcomes.",[498,26],"Ulcerative Colitis (UC)",[500,501,26,27,502],"proton pumb inhibitor","PPI","PPI Withdrawal","2026-07-06",{"date":505,"type":36},"2026-07-08",{"date":507,"type":21},"2026-07-01",{"date":509,"type":21},"2027-07-01",{"name":511,"class":147},"University of Nottingham",{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":44},"100611566","a-study-to-observe-real-world-evidence-of-guselkumab-treatment-in-participants-with-ulcerative-colitis-and-crohns-disease-in-the-united-kingdom-uk-100611566","NCT07242248","A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)","Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK","GUSTO-UK","Inclusion Criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's\u002F Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician)\n* Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records\n* Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion Criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included\n* Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and \u002For small molecules)\n* Is unable to provide informed consent",{"count":521,"type":21},220,"The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[25,376,26],"2026-07-02",{"date":503,"type":36},{"date":527,"type":36},"2025-11-17",{"date":529,"type":21},"2029-03-17",{"name":531,"class":70},"Janssen-Cilag Ltd.",{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":556,"startDateStruct":557,"completionDateStruct":558,"leadSponsor":560,"locationsCount":44},"100600813","a-study-to-generate-real-world-evidence-of-guselkumab-effectiveness-in-inflammatory-bowel-disease-in-germany-100600813","NCT07102368","A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany","Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects","GORGEOUS","Inclusion Criteria:\n\n1. Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics\n2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements\n3. By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study\n\nExclusion Criteria:\n\n1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy\n2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included\n3. Has had a colectomy and\u002For a pouch\n4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \\& Johnson (J\\&J)",{"count":541,"type":21},500,"The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.",[25,376,26],[545,27,26,546,547,548,549,550,551,108,376,552,553,554,555],"IBD","Gastroenteritis","Gastrointestinal Diseases","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Pathologic Processes","Ulcer","Guselkumab","Tremfya","Inflammatory",{"date":503,"type":36},{"date":406,"type":36},{"date":559,"type":21},"2029-01-15",{"name":561,"class":70},"Janssen-Cilag G.m.b.H",{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":436,"enrollmentInfo":569,"targetDuration":4,"studyType":56,"phases":571,"briefSummary":572,"conditions":573,"keywords":574,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":582},"100534025","phase-2-a-study-on-the-safety-of-tak-279-and-whether-it-can-reduce-inflammation-in-the-bowel-of-participants-with-moderately-to-severely-active-crohns-disease-100534025","NCT06233461","A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease","A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease","Inclusion Criteria:\n\n1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \\>=19 years of age.\n2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.\n3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.\n\nExclusion Criteria:\n\n1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and\u002For ulcerative colitis.\n2. Have complications of CD that might require surgery during the study.\n3. Participants with a current ostomy.\n4. Participants who have failed 3 or more classes of advanced therapies.",{"count":570,"type":21},268,[105],"Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation.\n\nThe participants will be treated with TAK-279 for 52 weeks (1 year).\n\nDuring the study, participants will visit their study clinic 15 times.",[26],[209,575],"Latitude CD, Latitude Research Program",{"date":503,"type":36},{"date":578,"type":36},"2024-03-05",{"date":580,"type":21},"2027-07-23",{"name":195,"class":70},190,{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":16,"minAge":269,"maxAge":270,"enrollmentInfo":591,"targetDuration":4,"studyType":56,"phases":592,"briefSummary":593,"conditions":594,"keywords":595,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":597,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":601,"locationsCount":602},"100510179","phase-3-a-study-of-guselkumab-in-pediatric-participants-with-moderately-to-severely-active-crohns-disease-100510179","NCT05923073","A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease","A Phase 3, Multicenter, Randomized, Platform Study of p19 Inhibition of the IL-23 Pathway to Establish Efficacy in Pediatric Crohn's Disease","MACARONI-23","Inclusion Criteria:\n\n* Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria.\n* Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \\[PCDAI\\] score greater than or equal to \\[\\>=\\] 30)\n* Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\\>=) 6 (or \\>=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0\n* Participants must have a history of inadequate response, loss of response, or intolerance to immunomodulators (6-MP, AZA, or MTX), oral or IV corticosteroids, or biologic therapy\u002FJAK inhibitor therapy; OR have a history of corticosteroid dependence; OR have a history of inadequate response to exclusive enteral nutrition (EEN)\n\nExclusion Criteria:\n\n* Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery.\n* Participants must not have an abscess\n* Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline",{"count":132,"type":21},[58],"The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.",[26],[596],"Pediatric, Inflammatory bowel disease",{"date":503,"type":36},{"date":281,"type":36},{"date":600,"type":21},"2028-07-12",{"name":386,"class":70},85,{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":16,"minAge":79,"maxAge":80,"enrollmentInfo":611,"targetDuration":4,"studyType":56,"phases":613,"briefSummary":614,"conditions":615,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"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":612,"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":507,"type":36},{"date":619,"type":36},"2025-10-01",{"date":621,"type":21},"2029-05-14",{"name":623,"class":70},"Sanofi",301]