[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,164,0,25,[9,45,70,92,115,138,163,183,216,237,263,285,308,329,356,383,405,427,448,467,488,518,552,573,595],{"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":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100628557","phase-2-a-study-to-evaluate-efficacy-and-safety-of-mk-8690-in-participants-with-moderately-to-severely-active-ulcerative-colitis-mk-8690-002-100628557","NCT07463183","A Study to Evaluate Efficacy and Safety of MK-8690 in Participants With Moderately to Severely Active Ulcerative Colitis (MK-8690-002)","A Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-8690 in Adult Participants With Moderately to Severely Active Ulcerative Colitis","The main inclusion criteria include but are not limited to the following:\n\n* Has had ulcerative colitis (UC) (from onset of symptoms) for at least 3 months before Randomization\n* Has moderately to severely active UC\n* Has a weight ≥40 kg\n* Satisfies at least 1 of the criteria: Has had an inadequate response or loss of response to 1 or more protocol-specified treatments; protocol specified corticosteroid dependence; has been intolerant to 1 or more protocol-specified UC treatments\n* Is on treatment with any protocol-specified drugs during the study and meets drug stabilization requirements, as applicable\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of Crohn's Disease (CD) or indeterminate colitis (inflammatory bowel disease (IBD)-undefined) or other types of colitis or enteritis that may confound efficacy assessment\n* Has a current diagnosis of fulminant colitis and\u002For toxic megacolon\n* Has UC limited to the rectum\n* Has a current or impending need for colostomy or ileostomy\n* Has had a total proctocolectomy or partial colectomy\n* Has UC exacerbation requiring hospitalization within 2 weeks before Screening\n* Has any active infection as specified in the protocol\n* Is known to be infected with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)\n* Has evidence of active tuberculosis (TB) or meets TB exclusionary parameters\n* Has a history of cancer (except fully treated nonmelanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years before Randomization or has a history of colorectal cancer at any time\n* Has prior or current evidence of definite colonic dysplasia except for low-grade dysplasia that has been completely removed\n* Has had major surgery within 3 months before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study\n* Has received protocol-specified prohibited medications","75 Years",{"count":20,"type":21},"INTERVENTIONAL",[56],"PHASE2","The purpose of this protocol is to evaluate the efficacy of MK-8690 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that MK-8690 is superior to placebo with respect to the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.",[59,27],"Colitis Ulcerative","RECRUITING",{"date":35,"type":36},{"date":63,"type":36},"2026-03-24",{"date":65,"type":21},"2028-12-21",{"name":67,"class":68},"Merck Sharp & Dohme LLC","INDUSTRY",28,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":54,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":91},"100607249","phase-2-ly4268989-morf-057-co-administered-with-mirikizumab-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100607249","NCT07186101","LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:","A Phase 2, Multicenter, Randomized, Double-Blind, Active-Controlled Study of LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis","TOPAZ-UC","Inclusion Criteria:\n\n* Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC\n* Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1.\n* Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization\n* Are up-to-date on colorectal cancer surveillance per local society guidelines\n* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:\n* Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)\n\nNOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)\n\n* Advanced therapy-failed participants: Participants who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as:\n\n  * a biologic or biosimilar medication such as anti-tumor necrosis factor (anti-TNF) antibodies or anti-interleukin antibodies (IL-12\u002F23, or IL-23p19), except for\n\n    * mirikizumab.\n  * Janus kinase inhibitors (JAK) such as filgotinib, tofacitinib, or upadacitinib\n  * sphingosine 1-phosphate receptor 1 inhibitors (S1PR) such as etrasimod or ozanimod\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed\n\nNote: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply\n\n* Have a current or recent acute, active infection","80 Years",{"count":80,"type":21},252,[56],"The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).\n\nStudy participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.",[27],{"date":35,"type":36},{"date":86,"type":36},"2025-11-10",{"date":88,"type":21},"2029-03",{"name":90,"class":68},"Eli Lilly and Company",147,{"id":93,"slug":94,"hasResults":12,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":54,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100588107","phase-3-mirikizumab-administered-at-the-same-time-as-tirzepatide-in-adult-participants-with-moderately-to-severely-active-ulcerative-colitis-and-obesity-or-overweight-phase-3b-study-100588107","NCT06937086","Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study","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 Ulcerative Colitis and Obesity or Overweight","COMMIT-UC","Inclusion Criteria:\n\n* Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.\n* Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.\n* Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.\n* Have obesity, \\[body mass index (BMI) 30 kilograms per meter squared (kg\u002Fm2)\\]\n* Have overweight (BMI ≥27 kg\u002Fm2 to \\\u003C30 kg\u002Fm2) and in the presence of at least 1 of these 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 an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and\u002For who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.\n\nExclusion Criteria:\n\n* Have a current diagnosis of:\n\n  * Crohn's disease\n  * inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis.\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery.\n* Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.\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 a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.\n* Have a current or recent acute, active infection.","70 Years",{"count":102,"type":21},350,[104],"PHASE3","The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.\n\nParticipation in this study will last up to 61 weeks, including 52 weeks of treatment.",[27,107],"Obesity or Overweight",{"date":35,"type":36},{"date":110,"type":36},"2025-06-26",{"date":112,"type":21},"2028-04",{"name":90,"class":68},188,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":12,"sex":16,"minAge":123,"maxAge":78,"enrollmentInfo":124,"targetDuration":4,"studyType":54,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100607164","phase-3-an-induction-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607164","NCT07184996","An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","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 Ulcerative Colitis.","SUNSCAPE-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 UC 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\n\nExclusion Criteria:\n\n* Participants with Crohn's Disease (CD), indeterminate colitis\n* Current diagnosis of Ulcerative Proctitis\n* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \\>3 bowel resections\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapies prior to baseline\n* Participants with prohibited medications or therapies prior to baseline\n* Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","16 Years",{"count":125,"type":21},980,[104],"This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). Study details include:\n\nThe study duration may be up to 35 weeks with:\n\n* 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* 45 days follow-up visit for participants who do not enroll into the maintenance study (EFC18359)\n\nThe treatment duration will be up to 12 weeks in each sub-study. The number of scheduled on-site visits will be up to 8 for the Sub-Study 1 and Sub Study 2 or a maximum of 15 visits for participants completing extended induction.",[27],"2026-08-19",{"date":33,"type":36},{"date":132,"type":36},"2025-10-08",{"date":134,"type":21},"2028-05-09",{"name":136,"class":68},"Sanofi",219,{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":54,"phases":150,"briefSummary":151,"conditions":152,"keywords":153,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":162},"100598440","phase-3-a-study-to-learn-more-about-how-risankizumab-works-in-young-participants-with-ulcerative-colitis-100598440","NCT07071519","A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis","A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to \u003C 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis","MIGHTY","Inclusion Criteria:\n\n* Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).\n* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:\n\naminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and\u002For biologic therapies, as outlined in the protocol.\n\n\\- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and\u002For malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.\n\nExclusion Criteria:\n\n* Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).\n* Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.","2 Years","17 Years",{"count":149,"type":21},120,[104],"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.\n\nRisankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.\n\nParticipants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. 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, checking for side effects and completing questionnaires.",[27],[154],"risankizumab",{"date":35,"type":36},{"date":157,"type":36},"2025-07-28",{"date":159,"type":21},"2034-07",{"name":161,"class":68},"AbbVie",56,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":170,"targetDuration":4,"studyType":54,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100565013","phase-2-a-study-to-test-whether-bi-3032950-helps-people-with-ulcerative-colitis-100565013","NCT06636656","A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis","Phase IIa, Sequential Cohort, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis","Inclusion criteria\n\n* Female and male participants aged 18 to 80 years (inclusive) at the time of informed consent,\n* Diagnosis of ulcerative colitis (UC) ≥3 months prior to screening by clinical and endoscopic evidence corroborated by a histopathology report,\n* Inadequate response, loss of response, or intolerance to treatment with biologic\u002Ftargeted therapy or termination of treatment with biologic\u002Ftargeted therapy for any other reason,\n* Female participants of childbearing potential must be ready and able to use highly effective methods of birth control and male participants are required to use condoms,\n* Further inclusion criteria apply.\n\nExclusion criteria\n\n* Diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis, or Crohn's disease (CD),\n* Findings suggestive of CD (e.g. fistulae, granulomas on biopsy),\n* Evidence of colonic moderate\u002Fsevere mucosal dysplasia or colonic adenomas, unless properly removed,\n* Gastrointestinal neoplasia, primary sclerosing cholangitis, or known colonic stricture,\n* Evidence of fulminant colitis or toxic megacolon at screening,\n* Current ileal-pouch anal anastomosis, ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine,\n* Previous surgery or anticipated surgical intervention for UC (trial participants with previous colonic surgery may be allowed based on investigator's judgement after discussion with the sponsor),\n* Any current or prior abscesses, unless they have been drained and treated at least 6 weeks prior to first trial drug administration and are not anticipated to require surgery,\n* Further exclusion criteria apply.",{"count":171,"type":21},80,[56],"Adults between 18 and 80 years of age with ulcerative colitis can participate in this study. This is a study for people for whom previous treatment was not successful or who stopped previous treatment. The purpose of this study is to find out whether BI 3032950 helps people with ulcerative colitis.\n\nThis study has 2 parts. In Part A, participants get BI 3032950 as an infusion into a vein every 4 weeks. After 12 weeks, doctors check whether the signs and symptoms of ulcerative colitis have improved. Before the results of this assessment are available, participants move on to Part B and get BI 3032950 as an injection under the skin. Participants whose results show clinical response after 12 weeks can continue treatment with BI 3032950. They get BI 3032950 injections under the skin every 4 weeks for up to 2 years.\n\nParticipants visit their doctors every 4 weeks. During these visits, the doctors check the signs and symptoms of ulcerative colitis. This includes taking blood and stool samples. Doctors also do endoscopies. This is a procedure that uses a tube with a camera to look inside the body.\n\nThe doctors also regularly check participants' health and take note of any unwanted effects.",[27],{"date":35,"type":36},{"date":177,"type":36},"2024-12-11",{"date":179,"type":21},"2029-07-30",{"name":181,"class":68},"Boehringer Ingelheim",41,{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":189,"phases":4,"briefSummary":190,"conditions":191,"keywords":205,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":215,"locationsCount":4},"100374756","expanded-access-to-upadacitinib-100374756","NCT04159597","Expanded Access to Upadacitinib","Exclusion Criteria:\n\n* There are other suitable treatment options.\n* The participant qualifies for ongoing clinical trials.","EXPANDED_ACCESS","This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to upadacitinib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.",[192,27,193,194,195,196,197,198,199,200,201,202,203,204],"Crohn Disease","Idiopathic Arthritis (Including sJIA, pJIA, or JPsA)","Atopic Dermatitis","Rheumatoid Arthritis","Psoriatic Arthritis","Axial Spondyloarthritis","Non-radiographic Axial","Spondyloarthritis","Giant Cell Arteritis","Systemic Lupus Erythematosus","Alopecia Areata","Non Segmental Vitiligo","Hidradenitis Suppurativa",[206,207,208,209,210,211],"Expanded Access","Pre-approval Access","Compassionate Use","Special Access Program","Named Patient Basis","Special Access Scheme","AVAILABLE","2026-08-18",{"date":33,"type":36},{"name":161,"class":68},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":16,"minAge":123,"maxAge":78,"enrollmentInfo":224,"targetDuration":4,"studyType":54,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},"100607165","phase-3-a-maintenance-study-to-investigate-the-efficacy-and-safety-of-duvakitug-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100607165","NCT07185009","A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis","SUNSCAPE-2","Inclusion Criteria:\n\n* Participants aged ≥18 and ≤80 years of age at Baseline. (Where locally permissible, participants 16 to \\\u003C18 years of age who meet the definition of Tanner stage 5 for development)\n* Pivotal Maintenance Sub-Study: Participants who achieved clinical response and completed endoscopy at the end of SUNSCAPE-1\n* OLE Sub-Study: Participants who complete the Pivotal Maintenance Sub-Study or participation in the TV48574-IMM-20038 Study\n\nExclusion Criteria:\n\n* Participants with medical or compliance conditions that are deemed unsuitable for the study by the investigator\n* Participants with a known hypersensitivity to duvakitug that makes the participant unsuitable for the study by the investigator\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":225,"type":21},751,[104],"This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).\n\nStudy details include:\n\nThe study duration may be up to 286 weeks including:\n\n* 40-week Pivotal Maintenance Sub-Study\n* 240-week Open-Label Extension (OLE) Sub-Study\n* 45-day Follow-up Visit Note: For the participants who do not enroll into OLE Sub-Study, the duration will be up to 46 weeks, including the 40-week maintenance period and a 45-day follow-up visit.\n\nThe treatment duration may be up to 280 weeks including:\n\n* 40 weeks in Pivotal Maintenance Sub-Study\n* 240 weeks in OLE Sub-Study\n\nThe total number of on-site visit will be up to 32:\n\n* 21 visits in the Pivotal Maintenance Sub-Study.\n* 11 visits in the OLE Sub-Study.",[27],"2026-08-17",{"date":213,"type":36},{"date":232,"type":36},"2026-01-16",{"date":234,"type":21},"2033-04-28",{"name":136,"class":68},46,{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":16,"minAge":245,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100603407","study-to-assess-change-in-disease-activity-of-risankizumab-treatment-in-japanese-participants-with-moderate-to-severe-ulcerative-colitis-100603407","NCT07136116","Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis","A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)","RISE UP","Inclusion Criteria:\n\n* Participants with a diagnosis of moderate to severe Ulcerative Colitis (UC) commenced on Risankizumab (RZB) treatment prescribed as part of their routine clinical care at their clinical's discretion according to Japan approved label and treatment prescription recommendations\u002Fguidelines.\n* The decision to prescribe RZB is made prior to and independently of study participation.\n* Participants able to provide voluntary informed consent before any study-related activities or procedures (obtained\u002Fdocumented as per regulations). If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent.\n* Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone) and continued PRO data collection after cessation of RZB.\n* Participants without previous exposure to RZB.\n* Participants who are not currently participating in interventional research (not including non-interventional studies, PMOS, or registry participation).\n\nExclusion Criteria:\n\nSee Inclusion Criteria","15 Years",{"count":247,"type":21},200,"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.\n\nRisankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 30 sites across Japan.\n\nParticipants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 156 weeks.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.",[27],[251,252,253],"Ulcerative colitis","Risankizumab","SKYRIZI","2026-08-13",{"date":256,"type":36},"2026-08-14",{"date":258,"type":36},"2025-10-09",{"date":260,"type":21},"2030-02",{"name":161,"class":68},29,{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":271,"targetDuration":4,"studyType":54,"phases":273,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":284},"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":272,"type":21},400,[274],"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],{"date":256,"type":36},{"date":279,"type":36},"2025-03-27",{"date":281,"type":21},"2028-06-01",{"name":283,"class":68},"Takeda",101,{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":16,"minAge":293,"maxAge":17,"enrollmentInfo":294,"targetDuration":4,"studyType":54,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":307},"100582600","phase-3-a-study-evaluating-the-effects-of-filgotinib-in-children-and-teenagers-with-ulcerative-colitis-100582600","NCT06865417","A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis","A Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Filgotinib, With Single Arm Induction and Maintenance, in Pediatric Subjects (8 to \u003C18 Years of Age) With Moderately to Severely Active Ulcerative Colitis","Galapeduca","Inclusion Criteria:\n\n* Subject must have a minimum body weight (BW) of 15 kg.\n* Subject:\n\n  * has documented diagnosis of UC with a minimum duration of 3 months,\n  * has mMCS of 5 to 9, and an MCS endoscopic score \\>=2, rectal bleeding \\>=1, and stool frequency \\>=1,\n  * has had an inadequate response, loss of response, intolerance, or has medical contraindications to corticosteroids, immunosuppressants, and\u002For biologic therapy. This includes subjects who depend on corticosteroids to control their symptoms and who experience worsening of their disease when attempting to wean off corticosteroids.\n\nExclusion Criteria:\n\n* Subject has a diagnosis of inflammatory bowel disease -unclassified or indeterminate colitis, isolated proctitis, or toxic megacolon.\n* Subject has an active infection.\n* Subject with a history of complicated herpes zoster infection (with multi-dermatomal, disseminated, ophthalmic, or central nervous system involvement).\n* Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes simplex, herpes zoster, or atypical mycobacteria).\n* Subject has a history of colectomy or extensive small bowel resection.\n* Subject with psychological or cognitive difficulties that might interfere with study participation.\n* Subject has any previous exposure to a Janus kinase inhibitor or medication with a similar mode of action (e.g. tofacitinib, baricitinib, upadacitinib).\n* Female subject is pregnant or breast feeding or intending to become pregnant or breastfeed during the study.","8 Years",{"count":171,"type":21},[104],"The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years.\n\nApproximately 80 subjects from 8 to \\\u003C18 years of age with moderately to severely active UC, including a minimum of 8 subjects from 8 to \\\u003C12 years of age, will be enrolled in this study.\n\nDuring the study, eligible subjects will take the investigational product (IP) on-site at Week 4, Week 10, and Week 22 (in the morning; with or without food). On all other days, subjects will take IP at home (in the morning; with or without food).\n\nSubjects who do not achieve mMCS remission and\u002For MCS response at Week 10 will continue with induction treatment until Week 22. Subjects who do not achieve PUCAI remission at Week 22 will be permanently discontinued from the study.\n\nSubjects will all receive a filgotinib dose targeting the same systemic exposure as that observed in adults with UC treated with 200 mg q.d.",[27],"2026-08-11",{"date":300,"type":36},"2026-08-12",{"date":302,"type":36},"2025-09-29",{"date":304,"type":21},"2028-06",{"name":306,"class":68},"Alfasigma S.p.A.",47,{"id":309,"slug":310,"hasResults":12,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":54,"phases":318,"briefSummary":319,"conditions":320,"keywords":321,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":236},"100523395","phase-4-a-study-of-vedolizumab-with-tofacitinib-in-adults-with-ulcerative-colitis-uc-100523395","NCT06095128","A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)","An Open-Label, Phase 4, Single-Arm, Multicenter Study to Evaluate the Induction of Response and Remission of Vedolizumab Dual Targeted Therapy With Tofacitinib in Adult Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.\n2. Has moderately to severely active UC as determined by a complete Mayo score \\[including physician's global assessment (PGA)\\] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.\n3. Has evidence of UC extending proximally to the rectum \\[≥15 centimeter (cm) of involved colon\\].\n4. Participants with extensive colitis or pancolitis of \\>8 years duration or left sided colitis \\>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.\n5. Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \\>50 years, or other known risk factors must be up to date on colorectal cancer surveillance.\n6. Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Participants without prior failure or intolerance to biologics are not eligible. Participants who discontinued TNFα antagonist therapy for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the medical monitor.\n\n   Note: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate. Participants who discontinued biologics for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the Medical Monitor.\n7. If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 40 mg daily of prednisone or 9 mg daily of budesonide, or equivalent for at least 2 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.\n\nExclusion Criteria:\n\nGastrointestinal Exclusion criteria:\n\n1. Has any of the following UC-related complications:\n\n   1. Acute severe UC.\n   2. The participant has had extensive colonic resection, subtotal or total colectomy.\n   3. The participant has clinical evidence of abdominal abscess or toxic megacolon.\n   4. The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.\n   5. Short bowel syndrome.\n2. Has Crohn's colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID) induced colitis, idiopathic colitis (i.e, colitis not consistent with UC), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption. Participants with a history of colonic mucosal dysplasia are also excluded.\n3. Has uncontrolled primary sclerosing cholangitis.\n\nInfectious Disease Exclusion Criteria:\n\n1. Has any evidence of an active systemic infection during screening. Participants with nonsystemic infections (eg, active fungal infection of nail beds) may be eligible, if in the opinion of the investigator, inclusion of the participant will not interfere with the collection or interpretation of study results and poses no risk to the participant.\n2. Has active or latent tuberculosis (TB), regardless of treatment history, as evidenced by any of the following:\n\n   1. History of TB.\n   2. A diagnostic TB test performed during screening that is positive, as defined by:\n\n   i. A positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests or ii. A tuberculin skin test reaction ≥10 mm (≥5 mm in subjects receiving the equivalent of \\>15 mg daily prednisone).\n3. A positive test for hepatitis B virus (HBV).\n4. A positive test for hepatitis C virus (HCV).\n5. Evidence of, or treatment for, Clostridium difficile infection or other intestinal pathogen within 28 days prior to first dose of study treatment. Participants who test positive for C. difficile or other intestinal pathogens at screening and receive treatment may be enrolled or rescreened (if required) following confirmation of infection resolution.\n6. Evidence of active Cytomegalovirus (CMV) infection at screening.\n\nMedication exclusion criteria:\n\n1. Has received immunomodulators (eg, 6-mercaptopurine, azathioprine, and methotrexate) within 4 weeks prior to first dose or immunosuppressants (eg, cyclosporine, tacrolimus) within 8 weeks prior to first dose.\n2. Any medicinal product, herbal medication, or natural health product which might interfere with cytochrome P450 genotype 3A4 (CYP3A4) within 2 weeks prior to enrollment, except for any CYP3A4 modulator used to treat a C. difficile or an intestinal pathogen infection at screening.\n3. Has received any of the following medical therapies for UC:\n\n   1. IV antibiotics within 8 weeks prior to enrollment.\n   2. Any rectal therapy for treatment of UC within 2 weeks prior to screening endoscopy.\n   3. Chronic NSAID use defined as daily use for \\>2 consecutive weeks (Note: occasional use \\[\\\u003C2 consecutive weeks\\] of NSAIDs and acetaminophen \\[\\\u003C100 mg daily\\] for headache, arthritis, myalgias, or menstrual cramps and chronic low dose aspirin use \\[81-162.5 mg daily\\] for cardiovascular prophylaxis are permitted).\n4. Has received a live virus or live bacterial vaccine within 4 weeks prior to enrollment or planned vaccination during the study and for 12 weeks after last dose.\n\nGeneral Exclusion Criteria:\n\n1. Has any of the following cardiovascular or thrombotic conditions:\n\n   1. Recent (within past 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting.\n   2. Recent (within past 6 months) moderate to severe congestive heart failure (New York Heart Association class III or IV).\n   3. Prior history of thrombotic events, including deep vein thrombosis and pulmonary embolism.\n   4. Known inherited conditions that predispose to hypercoagulability.\n2. History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and\u002For splenomegaly.\n3. A surgical procedure requiring general anesthesia within 3 months prior to screening or is planning to undergo major surgery during the study period.\n4. Any investigational procedure ≤4 weeks prior to screening that, in the investigator's opinion, may interfere with interpretation of study results.","65 Years",{"count":317,"type":21},65,[274],"The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim is to learn about treatment with Vedolizumab alone after the double treatment.\n\nAll participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks.\n\nEach participant will be followed up for at least 26 weeks after the last dose of vedolizumab.",[27],[322],"Drug Therapy",{"date":300,"type":36},{"date":325,"type":36},"2024-06-12",{"date":327,"type":21},"2027-07-09",{"name":283,"class":68},{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":337,"sex":16,"minAge":338,"maxAge":339,"enrollmentInfo":340,"targetDuration":342,"studyType":22,"phases":4,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":355},"100329603","pibd-setquality-the-inception-cohort-and-safety-registry-100329603","NCT03571373","PIBD-SETQuality: the Inception Cohort and Safety Registry","Paediatric Inflammatory Bowel Diseases Network for Safety, Efficacy, Treatment and Quality Improvement of Care: The PIBD-NET Inception Cohort and Safety Registry","PIBD-SETQ","Inclusion Criteria Inception cohort:\n\nNewly diagnosed patient, \\\u003C18 years of age, with a likely diagnosis of IBD or a confirmed diagnosis of IBD can be included in the study. In order to be eligible to continue in the study the subject must meet all of the following criteria:\n\n* Diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised Porto criteria (1)\n* Diagnosis has been made or is confirmed within 2 months of inclusion\n* Data on all diagnostic procedures are available for inclusion in the database\n* Informed consent of patient (if indicated) and parents has been obtained\n* Concerning the patients of whom biological specimens will be included: patients have not started IBD treatment yet\n\nInclusion Criteria Safety Registry:\n\nAny child with IBD \\\u003C19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. For the initial reporting of incident cases no patient identifiable details will be required.\n\nExclusion Criteria Inception cohort:\n\n* Inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study)\n* Informed consent of patient or parents has not been obtained when required\n* Patients on similar treatments as for IBD but for other conditions, or known with conditions directly affecting the IBD (e.g. immunodeficiency or major gastrointestinal resections)\n\nExclusion Criteria Safety registry: none.",true,"0 Years","19 Years",{"count":341,"type":21},1500,"20 Years","The purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (PIBD) and to correlate this to their individual risk factors.",[345,192,27],"Inflammatory Bowel Diseases","2026-08-07",{"date":298,"type":36},{"date":349,"type":36},"2017-01-03",{"date":351,"type":21},"2030-12-31",{"name":353,"class":354},"Erasmus Medical Center","OTHER",2,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":362,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":16,"minAge":146,"maxAge":339,"enrollmentInfo":364,"targetDuration":4,"studyType":54,"phases":366,"briefSummary":367,"conditions":368,"keywords":370,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"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.",{"count":365,"type":21},150,[104],"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.",[27,369,345,26],"Ulcerative Colitis Chronic",[371,372,373,374],"Pediatric Ulcerative Colitis","Pediatric Crohn's Disease","Pediatric UC","Pediatric CD","2026-08-06",{"date":346,"type":36},{"date":378,"type":36},"2021-05-26",{"date":380,"type":21},"2030-12",{"name":90,"class":68},68,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":337,"sex":16,"minAge":390,"maxAge":52,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":393,"conditions":394,"keywords":396,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":400,"startDateStruct":401,"completionDateStruct":4,"leadSponsor":403,"locationsCount":44},"100054259","immune-regulation-in-ulcerative-colitis-or-crohn-s-disease-100054259","NCT00001184","Immune Regulation in Ulcerative Colitis or Crohn s Disease","A Natural History Study of the Immune Regulation of Idiopathic Inflammatory Bowel Diseases: Crohn's Disease, Ulcerative Colitis, and Other Inflammatory Conditions of the Gut","* INCLUSION CRITERIA:\n\n  1. Patients with a verifiable diagnosis of Crohn s disease, ulcerative colitis, or IBD known to be associated with a co-existing condition and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal\n\n     changes OR\n  2. Patients with clinical features consistent with an unclassified inflammatory bowel disease and histologic evidence of inflammation of the intestine OR\n  3. Patients with any clinical features consistent with inflammatory bowel disease (intestinal inflammation), including but not limited to abdominal pain, fistulae, weight loss, diarrhea, hematochezia or melena or suggestive extra-intestinal symptoms (pyoderma, erythema\n\n     nodosum, axial and articular arthralgias, uveitis, fatigue, fever), in which a diagnosis has not been verified. OR\n  4. Patients who have a defined genetic syndrome linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n  5. All subjects to be enrolled will be between ages 0-75 (Participants coming to the NIH Clinical Center must meet age and weight requirements of the clinical center, but \\> 18 must years old for patients without IBD and may be as young as 0-2 years old for mail-in\n\n     samples).\n  6. To participate in the research biopsies during endoscopy, subjects must have the following lab values within two weeks of the procedure:\n\n     * Hematocrit \\> 30%\n     * Platelet count \\> 100,000\n     * PT INR \\\u003C 1.3 or PTT prolonged by \\\u003C 3 seconds\n  7. Ability to consent to the protocol on their own.\n\nINCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n1. Must be willing to undergo blood draw and\u002For upper endoscopy and colonoscopy with biopsy to obtain material for research purposes.\n2. Must be \\>=18 years old.\n3. Must be willing to submit samples for storage.\n\nINCLUSION OF EMPLOYEES IN THE NIH INTRAMURAL STUDIES:\n\nNIH employees and members of their immediate families may participate in this protocol. We will follow the Guidelines for the Inclusion of Employees in NIH Research Studies and will give each employee a copy of the NIH information sheet on Employee Research Participation.\n\nFor NIH employees:\n\n1. Neither participation nor refusal to participate will have an effect, either beneficial or adverse, on the participant s employment or work situation.\n2. The NIH information sheet regarding NIH employee research participation will be distributed to all potential subjects who are NIH employees.\n3. The employee subject s privacy and confidentiality will be preserved in accordance with NIH Clinical Center and NIAID policies, which define the scope and limitations of the protections.\n4. For NIH employee subjects, consent will be obtained by an individual independent of the employee s team. Those in a supervisory position to any employee and co-workers of the employee will not obtain consent. The protocol study staff will be trained annually on obtaining potentially sensitive and private information from co-workers or subordinates. This training will be reinforced as needed, at weekly team meetings.\n\nEXCLUSION CRITERIA:\n\n1. Failure to meet the inclusion criteria.\n2. Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the subject.\n\nEXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:\n\n1. History of inflammatory bowel disease.\n2. Acute systemic or intestinal infection requiring antibiotics\n3. Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study.","1 Day",{"count":392,"type":21},1000,"This study will investigate in patients with Crohn s disease and ulcerative colitis how the body s immune system controls inflammation in the gastrointestinal tract (stomach and intestines)-specifically, how lymphocytes (a type of white blood cell) function in inflammatory responses. This protocol does not involve any experimental treatments.\n\nPatients between the ages of 0 and 75 years of age with Crohn s disease or ulcerative colitis or symptoms of inflammatory bowel disease may be eligible for this study. Screening tests may include the following: medical history and physical examination, routine blood tests, examination of stool specimens, X-rays such as barium enema or upper GI series, proctosigmoidoscopy, colonoscopy, gastroduodenoscopy, and small bowel biopsy.\n\nParticipants will receive medical treatment according to the best generally accepted measures for treating Crohn s disease or ulcerative colitis. This may include anti-inflammatory drugs, immunosuppressive drugs, and antibiotics to treat infections. A surgical consultation may be recommended for patients whose disease does not respond to medical treatment. If surgery to remove intestinal tissue is recommended, a qualified gastrointestinal surgeon will perform the procedure.\n\nIn addition, participants may undergo the following procedures:\n\n* Blood drawing - No more than 450 milliliters (30 tablespoons, or 15 ounces) of blood will be taken from adults over a 6-week period. A maximum of 7 ml (1\u002F2 tablespoon) of blood per kilogram (2.2. pounds) of body weight will be obtained from children within the same time period, with no more than 3 ml\u002Fkg taken at any one time.\n* Leukapheresis - This procedure is done to collect large quantities of white blood cells. Whole blood is collected through a needle in an arm vein, similar to donating blood. The blood is circulated through a machine that separates it into its components, and the white cells are removed. The rest of the blood is returned to the body, either through the same needle or through another needle in the other arm.\n* Intestinal biopsies - Intestinal tissue will be obtained during colonoscopy with intestinal biopsy in patients who require this procedure as part of their standard medical care. Patients are given a sedative to reduce anxiety, but are conscious during the procedure. A flexible tube is inserted into the rectum and large intestine, allowing the physician to see the intestinal mucosa. At various places, small pieces of tissue are plucked out.",[25,27,395],"Chrohn's Disease",[397,398,399],"CGD related IBD","IBD Hermansky-Pudlak Syndrom","Natural History",{"date":346,"type":36},{"date":402,"type":36},"1998-08-07",{"name":404,"class":43},"National Institute of Allergy and Infectious Diseases (NIAID)",{"id":406,"slug":407,"hasResults":12,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":412,"targetDuration":4,"studyType":54,"phases":414,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":426},"100560017","boom-ibd2-pivotal-clinical-trial-100560017","NCT06571669","BOOM-IBD2 Pivotal Clinical Trial","BOOM-IBD2 Clinical Trial to Evaluate the Effectiveness of Sacral Neuromodulation for the Treatment of IBD.","Inclusion Criteria:\n\n* Male or female\n* 18 to 85 years of age\n* Diagnosed with ulcerative colitis\n* Ability and willingness to consent to participate by signing the informed consent form\n* Ability to comply with the protocol and willingness to comply with all follow up requirements\n\nExclusion Criteria:\n\n* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study\n* Any psychiatric or personality disorder at the discretion of the study investigator\n* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)\n* Active clostridium difficile infection of the colon\n* Active cytomegalovirus (CMV) infection of the colon\n* Evidence of colonic perforation\n* Fulminant colitis requiring emergency surgery\n* Microscopic, ischemic or infectious colitis\n* Unresected neoplasia of the colon\n* Colonic stricture unable to pass a colonoscope\n* Current evidence of cancer in the gastrointestinal tract\n* Current participation in another clinical trial\n* Previous history of surgery for ulcerative colitis, or probably to require such intervention\n* Previously implanted with a neurostimulation device or participated in a neurostimulation trial\n* Inability to operate the patient programmer",{"count":413,"type":21},137,[415],"NA","Ulcerative colitis is a long-lasting condition that causes swelling and sores in the large intestine. This study tests whether a small device placed under the skin can help reduce bowel urgency in people with ulcerative colitis. The investigational device sends mild signals to a nerve near the tailbone. It is placed during a same-day procedure.",[27,345],"2026-08-05",{"date":375,"type":36},{"date":421,"type":36},"2025-01-31",{"date":423,"type":21},"2027-11-30",{"name":425,"class":68},"Boomerang Medical",19,{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":54,"phases":436,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":447},"100456944","treat-to-target-of-endoscopic-remission-in-patients-with-ibd-in-symptomatic-remission-100456944","NCT05230173","Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission","QUOTIENT","INCLUSION CRITERIA:\n\nParticipants must meet all of the following criteria for enrolment into the study.\n\n1. Male or nonpregnant, nonlactating females, ≥ 18 years of age.\n2. An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.\n3. Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., TNFα antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial.\n4. Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy\u002Fradiology. No treatment escalation of TIM or addition of IMM, corticosteroid, or mesalamines after the qualifying endoscopy\u002Fradiology procedure up to randomization is permitted. Dose de-escalation after qualifying procedure is permissible at the discretion of the treating provider.\n5. In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experiencing no other IBD-related symptoms in the opinion of the treating provider. Includes patients who may be in medically induced remission (on index TIM); or surgically induced remission with post-op initiation of index TIM for prophylaxis and colonoscopy\u002Fimaging performed at least 3 months after initiation\u002Foptimization of TIM showing moderate-severe bowel inflammation. Validated PROs are defined as:\n\n   1. CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or\n   2. UC: PRO2, with absence of rectal bleeding (rectal bleeding score = 0) and with stool frequency score ≤1.\n6. Evidence of moderate to severe bowel inflammation on local reading of colonoscopy, flexible sigmoidoscopy, balloon-assisted enteroscopy, capsule endoscopy or MR, CT enterography, or intestinal ultrasound, performed within 6 months prior to screening, defined at the investigator's discretion or as follows:\n\n   1. CD: Colonoscopy showing moderately to severely active inflammation based on 1 of the following variables\u002Fscores:\n\n      * Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 or score ≥4 for those with isolated ileal disease, or\n      * Presence of mucosal ulcers \\>5 mm in size if SES-CD has not been recorded, or\n      * Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) score ≥2, or\n      * Rutgeerts score i2b or higher for patients in surgically induced remission with post-operative endoscopic recurrence \\[Note, either SES-CD or Rutgeerts score can be used for participants with post-operative recurrence\\]; or\n   2. CD: MRE or CTE showing moderately to severely active inflammation based on 1 of the following variables:\n\n      * Increased bowel wall thickness, or\n      * Mural hyperenhancement, or\n      * Peri-enteric fat stranding, or\n      * Radiographic features of ulceration, or\n      * Intramural T2 signal on fat suppressed images; or\n   3. CD: Capsule endoscopy showing moderately to severely active small bowel disease based on Lewis score \\>790 (in case the disease is not accessible via endoscopy), or per local endoscopist if Lewis score is not reported; or\n   4. CD: Gastrointestinal ultrasound showing at least 1 of the following variables:\n\n      * Increased bowel wall thickness \\>5 mm, or\n      * Color doppler score \\>5\u002Fcm2, or\n      * Bowel stenosis, or\n      * Bowel stratification, or\n      * Fatty wrapping; or\n   5. UC: modified MES score of 2 to 3, or documentation of any endoscopic feature that would define an MES of 2 to 3 (e.g., friability, ulceration, spontaneous bleeding, complete loss of vascular pattern), if an MES has not been recorded.\n7. Eligible to receive at least 1 alternative TIM (excluding their index TIM) for the treatment of their disease per approved drug label, based on clinical and reimbursement guidelines.\n8. Able to participate fully in all aspects of this clinical trial.\n9. Informed consent must be obtained and documented.\n\nEXCLUSION CRITERIA:\n\nParticipants who exhibit any of the following conditions are to be excluded from the study.\n\n1. Presence of ostomy or ileoanal pouches.\n2. Serious underlying disease other than UC or CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.\n3. History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.\n4. Prior enrolment in the current study.\n5. Mild endoscopic disease activity, where treating providers would not consider switching TIM.",{"count":435,"type":21},216,[415],"The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis \\[UC\\]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.",[27,192],"2026-08-04",{"date":346,"type":36},{"date":442,"type":36},"2022-10-05",{"date":444,"type":21},"2029-02-01",{"name":446,"class":354},"Mayo Clinic",24,{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":54,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":4},"100632959","microbiome-targeted-diet-therapy-in-ulcerative-colitis-100632959","NCT07520461","Microbiome-targeted Diet Therapy in Ulcerative Colitis","Inclusion Criteria:\n\n* Ability and willingness to provide informed consent\n* Age at least 18 years old\n* Diagnosis of UC based on clinical and endoscopic criteria\n* UC duration of at least 3 months\n* Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization\n* On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below).\n\n  1. ≥4 weeks if no medication, 5-ASA\n  2. ≥8 wk for immunomodulatory therapy\n  3. ≥12 wk for biologics\n* Ability to comply with study requirements in the opinion of the primary investigator\n\nExclusion Criteria:\n\n* Moderate or severe UC as defined by UCEIS ≥5\n* History of stomach surgery or bowel resection\n* Antibiotic use within 3 months\n* Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)\n* Pregnancy or breastfeeding\n* History of anaphylactic food allergies\n* Intolerance of high dietary fiber content\n* Ongoing alcohol or drug abuse\n* Habitual vegan diet pattern\n* Insufficient freezer space to accommodate meal delivery",{"count":455,"type":21},40,[415],"The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.",[27],"2026-08-03",{"date":418,"type":36},{"date":462,"type":21},"2026-09-07",{"date":464,"type":21},"2029-06-01",{"name":466,"class":354},"University of Minnesota",{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":474,"targetDuration":4,"studyType":54,"phases":476,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":487},"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":475,"type":21},70,[104],"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],[322],"2026-07-31",{"date":459,"type":36},{"date":483,"type":36},"2025-01-22",{"date":485,"type":21},"2028-05-16",{"name":283,"class":68},54,{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":495,"targetDuration":4,"studyType":54,"phases":497,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":517},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":496,"type":21},300,[498],"PHASE1","This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[501,192,502,503,25,504,505,506,196,195,507,201,508,27],"Autoimmune Disease","Dermatomyositis","Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Sjogren Syndrome","Systemic Scleroderma","2026-07-30",{"date":480,"type":36},{"date":512,"type":36},"2019-07-16",{"date":514,"type":21},"2028-03-30",{"name":516,"class":43},"National Cancer Institute (NCI)",52,{"id":519,"slug":520,"hasResults":12,"nctId":521,"briefTitle":522,"officialTitle":523,"acronym":4,"eligibilityCriteria":524,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":525,"targetDuration":4,"studyType":54,"phases":527,"briefSummary":528,"conditions":529,"keywords":530,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":551},"100562113","phase-2-a-study-of-eltrekibart-and-mirikizumab-in-adult-patients-with-moderately-to-severely-active-ulcerative-colitis-100562113","NCT06598943","A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis","An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Have had an established diagnosis of UC of ≥3 months in duration before baseline.\n* Have moderately to severely active UC as assessed by the UC disease activity score.\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).\n* Are on a stable dose of certain oral UC medications (including corticosteroids).\n* Must meet contraception requirements.\n\nExclusion Criteria:\n\n* Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.\n* Have experienced a thrombotic event within 24 weeks before baseline.\n* Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.\n* Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.\n* Have a history of certain adenomas, dysplasia's, or malignancies.",{"count":526,"type":21},143,[56],"The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).",[27,369],[531,532,533,345,534,535,536,537,538,539,540,541,542,543],"CXCR1\u002F2 Ligand receptor antagonist","IL-23 p19 antibody","Gastrointestinal Diseases","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Colitis","Colitis, Ulcerative","Anti-Inflammatory Agents","Mirikizumab","Eltrekibart","Adult","Moderate to Severe","2026-07-29",{"date":509,"type":36},{"date":547,"type":36},"2024-10-10",{"date":549,"type":21},"2028-09",{"name":90,"class":68},207,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":4,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":54,"phases":561,"briefSummary":562,"conditions":563,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":568,"leadSponsor":570,"locationsCount":572},"100591354","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-pk-of-ro7837195-in-participants-with-moderately-to-severely-active-ulcerative-colitis-uc-100591354","NCT06979336","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of RO7837195 in Participants With Moderately to Severely Active Ulcerative Colitis (UC)","A Phase IIb, Multicenter, Double-blind, Placebo-controlled Induction Study With an Active Treatment Extension to Assess the Efficacy, Safety, and Pharmacokinetics of RO7837195 in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Diagnosis of ulcerative colitis (UC) established at least 3 months\n* Moderately to severely active UC assessed by mMS\n* Inadequate response, loss of response, or intolerance to conventional or advanced therapies for UC\n\nExclusion Criteria:\n\n* Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC\n* Diagnosis of Crohn's disease or indeterminate colitis\n* Treatment with an advanced therapy targeted at tumor necrosis factor-like cytokine 1A (TL1a)\n* Inadequate response, loss of response, or intolerance to treatment of UC with an advanced therapy targeted at IL-12 and\u002For IL-23",{"count":560,"type":21},224,[56],"The purpose of this study is to evaluate the efficacy of RO7837195 compared with placebo in participants with moderately to severely active ulcerative colitis for whom prior treatment with conventional and\u002For advanced therapies has failed.",[27],"2026-07-26",{"date":566,"type":36},"2026-07-28",{"date":302,"type":36},{"date":569,"type":21},"2028-10-31",{"name":571,"class":68},"Genentech, Inc.",103,{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":581,"targetDuration":4,"studyType":54,"phases":583,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":44},"100648823","a-specific-probiotic-in-the-modulation-of-gut-microbiota-of-patients-with-mild-to-moderate-ulcerative-colitis-100648823","NCT07724990","A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis","A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study","ANEMONE","Inclusion Criteria:\n\n* Men or women 18 to 80 years of age at the time of consent\n* Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening\n* Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore \\>1 based on endoscopic evaluation performed during screening phase\n* Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg\u002Fday of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening\n* Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.\n\nExclusion Criteria:\n\n* concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12\u002F23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced\u002Fbiological drugs (even if belonging to the same class) will be excluded.\n* Intolerance to topical therapy (enemas)\n* Allergy to A. muciniphila or any other component of the IP\n* Crohn's disease or inflammatory bowel disease unclassified (IBD-U)\n* Subject who received IV\u002Fintramuscular corticosteroids within 14 days prior to Screening or during the Screening period.\n* Subject who received topical therapy (i.e., enema or suppository of aminosalicylates \u002F corticosteroids) within 14 days prior to Screening or during the Screening period.\n* Subject who received fecal microbial transplantation within 3 months prior to Baseline.\n* Subjects with the following chronic or active infections:\n\n  * Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study\n  * Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice,\n  * Are infected with human immunodeficiency virus (HIV),\n  * Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.\n* Pregnancy and breastfeeding",{"count":582,"type":21},20,[415],"Probiotics are live microorganisms that provide health benefits when consumed in sufficient amounts. Traditional probiotics, mainly from the Lactobacillus and Bifidobacterium genera, originate from fermented foods or the human gut and are widely used in supplements. Although considered safe and easy to produce, they are not specifically designed to treat diseases, and no official health claims have been approved by EFSA. Advances in microbiome research have led to the discovery of Next-Generation Probiotics (NGPs), which are newly identified gut microbes associated with health and offer promising therapeutic potential despite lacking a long history of safe use.",[27,192],"2026-07-24",{"date":588,"type":36},"2026-07-27",{"date":590,"type":36},"2025-05-14",{"date":592,"type":21},"2027-05-14",{"name":594,"class":354},"Catholic University of the Sacred Heart",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":601,"eligibilityCriteria":602,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":603,"targetDuration":4,"studyType":54,"phases":605,"briefSummary":606,"conditions":607,"keywords":608,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":44},"100644225","phase-4-combination-curqd-and-vedolizumab-in-ulcerative-colitis-100644225","NCT07665294","Combination CurQD and Vedolizumab in Ulcerative Colitis","CURVE-UC: A Pragmatic Randomized, Double-blind, Placebo Controlled, Treat-through, Multi-site Pragmatic Interventional Study to Evaluate the Efficacy and Safety of Combination Curcumin-QingDai (CurQD) With Vedolizumab in Moderate to Severe Ulcerative Colitis (UC)","Curve UC","Inclusion Criteria:\n\n* Age 18 to 80 years old (inclusive) at time of consent\n* Understand and sign the written voluntary informed consent form prior to any protocol specific procedures\n* History of established UC for \\>3 months as determined by standard clinical criteria\n* Active UC defined as a modified Mayo score of 5-9 with a rectal bleeding sub score \\[RBS\\] ≥1 and Mayo endoscopic score \\[MES\\] ≥2\n* Participant will have a minimum disease extent of at least 5 cm proximal from the anal verge\n* Subjects must be on stable doses of concomitant medications, defined as:\n\n  * Participants on oral corticosteroids must be on a stable dose \\>2 weeks (dose not exceeding 20 mg\u002Fday prednisone, 9mg\u002Fday of budesonide, or equivalent) prior to screening\n  * Participants on methotrexate (MTX), azathioprine (AZA), or 6-mercaptopurine (6-MP) must be on treatment at a stable dose \\>4 weeks prior to screening and until end of study\n  * Participants on oral 5-aminosalicylates, mesalamine, or sulfasalazine must be on a stable dose for \\>4 weeks prior to screening and until end of study\n  * Probiotics or anti-diarrheal at a stable dose ≥ 2 weeks prior to Screening and until the end of study\n* Participants who have been diagnosed with UC for ≥8 years must be up to date on their colorectal cancer screening per local guidelines by the time of randomization.\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease unclassified (IBD-U) or Crohn's colitis\n* Previously received VDZ or etrolizumab (another anti-integrin biologic therapy)\n* Receiving corticosteroids at a dose \\>20mg\u002Fday of prednisone within two weeks prior to enrollment\n* Participants who have been exposed to more than one advanced therapy medication (biologic or small molecule drug) before enrollment will be excluded\n* Receiving or planned concomitant biologic or small targeted small molecule advanced therapy (tumor necrosis factor antagonist, interleukin \\[IL\\]-12\u002F23 antagonist, IL-23 antagonist, Janus kinase \\[JAK\\] inhibitor and\u002For sphingosine-1-phosphate \\[S1P\\] receptor modulator) with vedolizumab\n* Any calcineurin inhibitor use within 4 weeks prior to screening (e.g., cyclosporine, tacrolimus)\n* Participant with known hepatitis B or C infection\n* Participant with active or latent tuberculosis (that has not been adequately treated)\n* Participant has any active infection\n* Participant has fecal sample positive for enteric infection at screening\n* History of prior colectomy or ileal pouch anal anastomosis\n* Participants with fulminant UC, toxic megacolon, or hospitalized for UC currently or within prior 2 weeks\n* Severe lab abnormalities including hemoglobin \\\u003C 8.0 g\u002Fdl, albumin \\\u003C 3.0 g\u002Fdl, platelets \\\u003C 100\u002Fmcl, AST \\> 2X upper limit of normal (ULN), ALT \\>2X ULN, total bilirubin \\>1.5X ULN\n* Participant with history of colon cancer or colonic dysplasia not adequately treated (i.e. polyp removed)\n* Any serious underlying disease other than UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as any unstable or uncontrolled medical disorder, class III or IV congestive heart failure, demyelinating disease)\n* History of primary sclerosing cholangitis\n* Renal impairment and reduced creatinine clearance defined as estimated glomerular filtration rate GFR (eGFR)\\\u003C60mL\u002Fmin\n* History of chronic liver disease (autoimmune hepatitis, cirrhosis, etc.)\n* Currently requiring total parental nutrition\n* History of solid organ transplantation\n* History of malignancy or lymphoproliferative disorder in the prior 5 years, other than\n* adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous\n* cell carcinoma, or nonmetastatic basal cell carcinoma of the skin.\n* History of venothromboembolism (DVT or PE) or known inherited or acquired hyper coagulation disorder\n* Currently taking anti-platelet agent (other than aspirin) or anti-coagulant (coumadin,\n* rivaroxaban, etc.)\n* History of human immunodeficiency virus (HIV) infection\n* Participant is pregnant or lactating or actively trying to become pregnant",{"count":604,"type":21},160,[274],"The purpose of this research study is to test the efficacy and safety of the study intervention, CurQD or placebo (non-active pill), in combination with vedolizumab prescribed as standard of care for patients with ulcerative colitis (UC)..",[27],[609],"ulcerative colitis",{"date":588,"type":36},{"date":612,"type":21},"2026-10-01",{"date":614,"type":21},"2027-06-23",{"name":616,"class":354},"Ryan C Ungaro"]