[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colitis-ulcerative\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colitis-ulcerative":58},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,43,0,25,[9,43,76,99,121,148,168,185,208,230,248,267,288,311,329,352,379,402,429,449,472,501,526,546,572],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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",false,"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","ALL","18 Years","75 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Colitis Ulcerative","Ulcerative Colitis","RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":34},"2026-03-24",{"date":38,"type":22},"2028-12-21",{"name":40,"class":41},"Merck Sharp & Dohme LLC","INDUSTRY",28,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100652680","intestinal-ultrasound-guided-management-in-inflammatory-bowel-disease-100652680","NCT07775352","Intestinal Ultrasound Guided Management in Inflammatory Bowel Disease","A Randomized Controlled Trial Comparing Standard of Care With and Without Intestinal Ultrasound Guidance in Patients With Inflammatory Bowel Diseases","Inclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease for more than 2 months\n* Age 18 years or older\n* Undergoing endoscopy at enrollment for assessment of disease severity\n\nExclusion Criteria:\n\n* Pregnancy\n* Unstable underlying medical conditions\n* Inflammatory bowel disease limited to the distal rectum (within 10 cm of the anal verge) or perianal disease only\n* Biologic failure",{"count":51,"type":22},137,[53],"NA","This randomized controlled trial evaluates whether adding point-of-care intestinal ultrasound (IUS) to standard of care changes clinical management in patients with inflammatory bowel disease (IBD). Adult patients with Crohn's disease or ulcerative colitis undergoing colonoscopy for disease assessment are randomized 1:1 to standard of care plus IUS at every visit, or standard of care alone, and followed for 48 weeks. The primary outcome is the proportion of patients with a change in treatment.",[56,57,58],"Inflammatory Bowel Diseases","Crohn Disease","Colitis, Ulcerative",[60,61,62,63,64,65],"intestinal ultrasound","IBD","point-of-care ultrasound","treat-to-target","bowel wall thickness","IBUS-SAS","2026-08-16",{"date":31,"type":34},{"date":69,"type":34},"2026-03-25",{"date":71,"type":22},"2028-03",{"name":73,"class":74},"Mahidol University","OTHER",1,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":75},"100651942","phase-1-a-study-to-evaluate-the-safety-tolerability-pk-and-preliminary-efficacy-of-hx15001-combined-with-etrasimod-in-moderate-severe-ulcerative-colitis-100651942","NCT07768254","A Study to Evaluate the Safety, Tolerability, PK and Preliminary Efficacy of HX15001 Combined With Etrasimod in Moderate-severe Ulcerative Colitis","Evaluation of the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HX15001 Injection Combined With Etrasimod Tablets in the Treatment of Moderate-severe Ulcerative Colitis: an Open-label, Exploratory Clinical Trial","Inclusion Criteria:\n\n* Patient able to read and understand, and willing to sign the informed consent form;\n* Weight≥40kg;\n* Clinical diagnosis of Ulcerative colitis (UC) that has been present for at least 3 years before the screening visit;\n* Mayo score of 5-9 at the baseline visits, including Mayo Endoscopic Score ≥2 and Rectal Bleeding Subscore ≥1, and disease extent from the anal verge ≥ 15 cm at screening.\n* Participants with a history of extensive colitis of ≥8 years' duration, or left-sided colitis of ≥10 years' duration, must have had a complete coloscopy within the past 1 year to exclude the presence fo dysplastic lesions.\n* Participants who have had an inadequate response to prior treatment with biologic agents or JAK inhibitors.\n* Willing and able to comply with clinic visits and study-related procedures.\n* Willing to use adequate birth control, if of reproductive potential and sexually active\n\nExclusion Criteria:\n\n* Evidence or history (within 6 months) of fulminant colitis, toxic megacolon, or intestinal perforation.\n* Prior colectomy (partial or total), or anticipated need for surgical intervention for UC during the study.\n* Prior or current diagnosis of Crohn's disease, fistulas\u002Fabscesses, indeterminate colitis, unclassified IBD, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, active diverticulitis, or other colitis\u002Fenteritis that may confound efficacy assessment.\n* Current unresolved colonic dysplasia, adenoma, adenomatous polyps, or neoplastic lesions. Patients with history of adenomatous polyps are eligible if polyps were completely removed (documented) and screening colonoscopy\u002Fhistology shows no residual polyps or dysplasia.\n* Concomitant primary sclerosing cholangitis or autoimmune hepatitis.\n* Malignancy within 5 years prior to screening, except fully resected non-metastatic basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, breast ductal carcinoma in situ, or papillary thyroid carcinoma with no recurrence.\n* Major surgery within 6 weeks prior to screening, or planned surgery during the study, unless judged not to increase patient risk or affect study compliance.\n* Any condition precluding endoscopic evaluation.\n* Unstable or poorly controlled cardiovascular (including atrial fibrillation requiring Class IA\u002FIII antiarrhythmics or QT-prolonging agents; unstable ischemic heart disease; Class I\u002FII heart failure; cardiac arrest; cerebrovascular disease; uncontrolled hypertension; symptomatic bradycardia; recurrent cardiogenic syncope; untreated severe sleep apnea; history of second-degree AV block without a functional pacemaker), respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurologic, or psychiatric disease that may compromise patient safety or confound efficacy assessment. - Patients requiring systemic corticosteroids for non-UC conditions (e.g., asthma, adrenal insufficiency, post-transplant) or with peripheral venous access issues are excluded.\n* Diabetes mellitus, uveitis, history of ocular surgery\u002Flaser, history of maculopathy, or active\u002Funcontrolled macular edema at screening.\n* Clinically significant 12-lead ECG abnormalities that may affect safety or interpretation, including QTcF \\>450 msec (males) or \\>470 msec (females), QRS \\>120 msec, or resting heart rate \\\u003C50 bpm (average of 3 measurements used for qualification).\n* Any of the following laboratory abnormalities:\n\n  1. Hemoglobin \\\u003C8.0 g\u002FdL\n  2. WBC \\\u003C2,500\u002Fmm³\n  3. Neutrophils \\\u003C1,000\u002Fmm³\n  4. Platelets \\\u003C100,000\u002Fmm³\n  5. Absolute lymphocyte count \\\u003C500\u002Fmm³\n  6. Serum creatinine \\>2× ULN\n  7. ALT or AST \\>2× ULN\n  8. Total bilirubin \\>1.5× ULN\n  9. Any other laboratory abnormality considered by the investigator to pose unacceptable risk.\n* History of alcohol, drug, or chemical abuse within 1 year prior to screening.\n* Receipt of live or live-attenuated vaccine within 3 months prior to Day 1, or planned during the study or within 5 weeks post-treatment. VZV antibody testing required for patients without documented history or complete vaccination; antibody-positive patients are eligible; antibody-negative patients may rescreen after complete VZV vaccination (≥4 weeks before etrasimod initiation).\n* Severe bacterial infection within 3 months (unless resolved with antibiotics), or chronic bacterial infection (e.g., pyelonephritis, osteomyelitis, bronchiectasis).\n* C. difficile infection within 30 days prior to Day 1 (may be retested once after 2 weeks of antibiotic therapy; persistent infection excludes enrollment).\n* Active invasive fungal infection (e.g., histoplasmosis) or parasitic infection.\n* Diagnosis of CMV colitis within 60 days (including screening period). CMV testing on colonic biopsy is required during screening only if clinically suspected.\n* Herpes zoster reactivation or CMV infection resolved within 2 months prior to screening.\n* Positive for HBsAg, or HBcAb positive with detectable HBV DNA; positive HCV antibody with detectable HCV RNA; positive Treponema pallidum antibody; or positive HIV antibody at screening.\n* Positive QuantiFERON-TB Gold or T-SPOT.TB test at screening.\n* Use of JAK inhibitors (e.g., tofacitinib, upadacitinib, filgotinib) within 4 weeks (or 5 half-lives, whichever is longer), or anti-TNF agents (e.g., adalimumab, infliximab), vedolizumab, or anti-IL-12\u002F23 agents (e.g., ustekinumab) within 8 weeks (or 5 half-lives, whichever is longer) prior to Day 1.\n* Prior S1P receptor modulator therapy without a 3-month washout.\n* Use of investigational chemical drugs within 30 days, or investigational biologics within 8 weeks (or 5 half-lives, whichever is longer) prior to Day 1.\n* IV corticosteroids within 2 weeks prior to Day 1 or planned during the study.\n* Corticosteroid enemas within 4 weeks, or corticosteroid suppositories and\u002For topical rectal 5-ASA within 2 weeks prior to Day 1, or planned during the study.\n* Topical (rectal) herbal enemas or suppositories within 1 week prior to Day 1 or planned during the study.\n* Immunosuppressants (e.g., tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, leflunomide, thalidomide) within 4 weeks (or 5 half-lives, whichever is longer) prior to Day 1 or planned during the study.\n* Immunoadsorption or fecal microbiota transplantation within 2 weeks prior to Day 1 or planned during the study.\n* NSAIDs (e.g., aspirin \\>100 mg\u002Fday) within 2 weeks prior to Day 1.\n* Immunoglobulin or blood products within 1 month prior to Day 1, or any condition likely to require such therapy during the study.",{"count":84,"type":22},32,[86],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HX15001 injection combined with Etrasimod tablets in participants with moderately to severely active ulcerative colitis (UC).",[58],"NOT_YET_RECRUITING","2026-08-13",{"date":92,"type":34},"2026-08-17",{"date":94,"type":22},"2026-09-09",{"date":96,"type":22},"2028-04-15",{"name":98,"class":41},"Helixon Biotechnology (Suzhou) Co., Ltd",{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":23,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":118,"locationsCount":120},"100630084","phase-2-a-master-protocol-iibd-a-study-of-multiple-drugs-in-adults-with-ulcerative-colitis-or-crohns-disease-100630084","NCT07483073","A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","Inclusion Criteria:\n\n* Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.\n* For UC:\n\n  * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1, with endoscopy performed within 21 days prior to Visit 2.\n* For CD:\n\n  * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease within 21 days before the randomization\n* Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD\n* Have screening laboratory test results within the protocol specified parameters.\n\nExclusion Criteria:\n\n* Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis\n\n  * For UC - must not have a current diagnosis of CD\n  * For CD - must not have a current diagnosis of UC\n* Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol\n* Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome\n* Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data\n* Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action\n* Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment\n* Must not have received or will need any prohibited medications for UC or CD as specified in the protocol","80 Years",{"count":108,"type":22},60,[25],"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.",[58,57],"2026-08-05",{"date":114,"type":34},"2026-08-06",{"date":116,"type":34},"2026-05-04",{"date":71,"type":22},{"name":119,"class":41},"Eli Lilly and Company",70,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100650420","phase-1-a-study-to-investigate-the-safety-and-tolerability-of-multiple-study-interventions-in-participants-with-moderate-to-severe-ulcerative-colitis-100650420","NCT07747467","A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis","A Phase 1b, Non-Randomized, Open-Label, Repeat-Dose, Single Center Study Utilizing a Master Protocol to Investigate the Safety and Tolerability of Multiple Study Interventions in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis","PEGASUS","Inclusion Criteria:\n\n* Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC, in the assessment of the investigator, must be available.\n* Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection.\n* Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy).\n* Documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before screening (may be performed during screening) for participants with pancolitis of \\>8 years duration or left-sided colitis of \\>12 years duration, or primary sclerosing cholangitis\n* Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines).\n* May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy\n\nExclusion Criteria:\n\n* Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis.\n* Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture\u002Fstenosis within the small bowel or colon.\n* Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy.\n* Have a history of malignant neoplasm within the last 5 years.\n* Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease\n* Have any active, chronic, or recurrent infections based on the investigator's assessment.\n* Have history of opportunistic infections within 1 year of screening (\n* Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data.\n* Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening.\n* Have significant allergies to humanized monoclonal antibodies.\n* Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions .\n* Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial.\n* Have ostomy or ileoanal pouch.\n* Have received any of the following for treatments of UC:\n\n  * Immunomodulatory medications, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, within 4 weeks before screening endoscopy.\n  * Topical (rectal) treatment of 5-ASA or corticosteroid enemas\u002Fsuppositories within 2 weeks of screening endoscopy.\n  * Have received approved or investigational advanced therapy (ATs) (i.e., biologics or small molecules including biosimilars).\n  * Interferon therapy within 8 weeks before screening endoscopy.\n  * Agents that deplete B- or T-cells (e.g., rituximab) within 12 months of baseline. Participants remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy.\n* Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy.\n* Participant must not have signs of an ongoing infection related to an intestinal pathogen.\n* In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* History of a significant allergic reaction (anaphylaxis, urticaria) or significant sensitivity to study intervention or any constituents of the study interventions (including excipients).\n* Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site.",{"count":130,"type":22},16,[86],"This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC). The platform design uses one single master protocol that explains how the overall study is organized, whereas each treatment, as sub-study will be tested to see how well the study drug works and how it affects participants.",[58],[29,135,136,137,138,139],"Anti-Interleukin-18 (anti-IL-18)","Inflammatory bowel disease","aletekitug","GSK1070806","Gastrointestinal Diseases","2026-07-31",{"date":112,"type":34},{"date":143,"type":22},"2026-08-10",{"date":145,"type":22},"2028-12-04",{"name":147,"class":41},"GlaxoSmithKline",{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100650419","a-study-of-continued-use-of-guselkumab-in-participants-with-crohns-disease-and-ulcerative-colitis-in-real-world-setting-100650419","NCT07746765","A Study of Continued Use of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting","Real-world Observational Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis","GusTaCon","Inclusion criteria:\n\n* Participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug\n* Participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records\n* Participant must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":157,"type":22},35,"OBSERVATIONAL","The purpose of this study is to find out how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.",[57,58],{"date":112,"type":34},{"date":163,"type":22},"2026-08-03",{"date":165,"type":22},"2029-08-03",{"name":167,"class":41},"Janssen Sciences Ireland UC",{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":183,"leadSponsor":184,"locationsCount":4},"100650416","phase-1-a-sub-study-to-investigate-the-safety-and-tolerability-of-aletekitug-in-participants-with-moderate-to-severe-ulcerative-colitis-100650416","NCT07747480","A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis","A Phase 1b, Non-Randomized, Open-Label, Repeat-Dose, Single Center Study to Investigate the Safety and Tolerability of Aletekitug in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis","Inclusion Criteria:\n\n* Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC must be available.\n* Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection.\n* Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy).\n* Documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before screening (may be performed during screening) for participants with pancolitis of \\>8 years duration or left-sided colitis of \\>12 years duration, or primary sclerosing cholangitis\n* Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines).\n* May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy.\n* Must meet contraception requirements if a female participant is a woman of childbearing potential (WOCBP)\n\nExclusion Criteria:\n\n* Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis. Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture\u002Fstenosis within the small bowel or colon.\n* Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy.\n* Have a history of malignant neoplasm within the last 5 years.\n* Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease\n* Have any active, chronic, or recurrent infections based on the investigator's assessment.\n* Have history of opportunistic infections within 1 year of screening\n* Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data.\n* Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening:\n* Have significant allergies to humanized monoclonal antibodies.\n* Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions\n* Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial.\n* Have ostomy or ileoanal pouch.\n* Have received any of the following for treatments of UC:\n\n  * Immunomodulatory medications, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, within 4 weeks before screening endoscopy.\n  * Topical (rectal) treatment of 5-ASA or corticosteroid enemas\u002Fsuppositories within 2 weeks of screening endoscopy.\n  * Have received approved or investigational advanced therapy (Ats) (i.e., biologics or small molecules including biosimilars).\n  * Interferon therapy within 8 weeks before screening endoscopy.\n  * Agents that deplete B- or T-cells (e.g., rituximab) within 12 months of baseline. Participants remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy.\n* Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy.\n* Participant must not have signs of an ongoing infection related to an intestinal pathogen.\n* In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site;\n* Uncontrolled hypertension (i.e., blood pressure consistently measures \\>=140\u002F90 millimeters of mercury (mmHg) while actively taking 1 or more antihypertensive medications).",{"count":130,"type":22},[86],"This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.",[58],[29,135,136,180,138,139],"Aletekitug",{"date":112,"type":34},{"date":143,"type":22},{"date":145,"type":22},{"name":147,"class":41},{"id":186,"slug":187,"hasResults":12,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100643529","phase-3-a-study-of-jnj-78934804-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100643529","NCT07577856","A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase 3 Randomized, Double-blind, and Active Controlled, Multi-center Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis","DUET ENCORE-UC","Inclusion criteria:\n\n* Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.\n* Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy\n* An endoscopy subscore \\>=2 as obtained during central review of the screening video endoscopy\n* Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies\n\nExclusion criteria:\n\n* Isolated proctitis (UC limited to the rectum only or to less than \\[\\\u003C\\] 20 centimeter \\[cm\\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD\n* Has a history of or ongoing chronic or recurrent infectious disease\n* Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab\n* Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention",{"count":194,"type":22},644,[196],"PHASE3","The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).",[58],"2026-07-30",{"date":140,"type":34},{"date":202,"type":34},"2026-05-23",{"date":204,"type":22},"2030-10-30",{"name":206,"class":41},"Janssen Research & Development, LLC",63,{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":215,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":224,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":75},"100642162","phase-4-a-study-to-assess-concentration-of-tremfya-in-breast-milk-of-lactating-women-who-are-receiving-tremfya-therapeutically-100642162","NCT07654751","A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","CNTO1959ISD4001: A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","Inclusion criteria:\n\n* Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \\[PsA\\], UC and CD) as confirmed by medical records\n* Be medically stable on the basis of medical history review performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator\n* Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1\n* Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study\n* Must be at least 5 weeks postpartum on Day 1\n* Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula\u002Fday) when enrolled in the study\n* Must plan to continue breastfeeding throughout the duration of the study\n\nExclusion criteria\n\n* Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments\n* Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening\n* Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study\n* Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \\[COVID-19\\]) by local health authorities are allowed\n* Has a positive urine pregnancy test on Day 1","FEMALE",{"count":217,"type":22},10,[219],"PHASE4","The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.",[222,58,57,223],"Psoriasis","Arthritis, Psoriatic",{"date":140,"type":34},{"date":226,"type":22},"2026-10-01",{"date":228,"type":22},"2027-08-31",{"name":206,"class":41},{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":236,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":75},"100638573","a-study-of-guselkumab-in-participants-with-crohns-disease-and-ulcerative-colitis-100638573","NCT07606339","A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis","Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis","G-FORCE","Inclusion criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration\n* Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records\n* Must sign a participation agreement\u002Finformed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent",{"count":157,"type":22},"The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.",[57,58],{"date":140,"type":34},{"date":243,"type":34},"2026-06-10",{"date":245,"type":22},"2029-06-15",{"name":247,"class":41},"Janssen-Cilag Pharma GmbH",{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":217},"100616188","a-real-world-study-of-guselkumab-in-chinese-participants-with-ulcerative-colitis-100616188","NCT07302360","A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis","Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study","GENIUS","Inclusion criteria:\n\n* Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\\>=) 2; c) Mayo rectal bleeding subscore (RBS) \\>= 1 at baseline\n* Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert\n* Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment\n* Participant (and\u002For their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy\n* Contraindicated to guselkumab per the label\n* Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab\n* Participants who will be receiving guselkumab therapy combined with a second advanced therapy\n* Participants with a history of colectomy and\u002For pouch",{"count":257,"type":22},200,"The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \\[part of large intestine\\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.",[58],{"date":140,"type":34},{"date":262,"type":34},"2025-12-11",{"date":264,"type":22},"2028-06-30",{"name":266,"class":41},"Xian-Janssen Pharmaceutical Ltd.",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":12,"sex":17,"minAge":275,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":23,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":287},"100608068","phase-3-a-protocol-of-icotrokinra-therapy-in-adult-and-adolescent-participants-with-moderately-to-severely-active-ulcerative-colitis-100608068","NCT07196748","A Protocol of Icotrokinra Therapy in Adult and Adolescent Participants With Moderately to Severely Active Ulcerative Colitis","A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults With an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis","ICONIC-UC","Inclusion Criteria:\n\n* Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC\n* Moderately to severely active UC, defined as a baseline (Week I-0) modified Mayo score of 5 to 9, inclusive, using the endoscopy subscore obtained during the central review of the screening video endoscopy\n* An endoscopy subscore greater than or equal to (\\>=) 2 as obtained during central review of the screening video endoscopy\n* Adolescent Participants: body weight must be \\>= 40 kilograms (kg) at baseline (Week I-0)\n* Adult female participants of childbearing potential and all adolescent female participants must have a negative highly sensitive serum pregnancy test (beta-human chorionic gonadotropin \\[β-hCG\\]) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests\n* Demonstrated an inadequate response to, or failure to tolerate conventional therapy but are naïve to advanced therapies (ADT naïve), or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and\u002For advanced oral agents for the treatment of UC (ADT-inadequate responder \\[IR\\]) as defined in the protocol\n\nExclusion Criteria:\n\n* Participants with current known complications of UC such as fulminant colitis, toxic megacolon, or any other manifestation that might require colonic surgery while enrolled in the study\n* Presence of a stoma\n* Presence or history of a fistula\n* Colonic resection within 24 weeks before baseline or any other intra-abdominal or other major surgery performed within 12 weeks before baseline\n* History of extensive colonic resection (that is, less than \\[\\\u003C\\] 30 centimeter \\[cm\\] of colon remaining) or colonic resection that could impair the use of disease severity assessments (for example Mayo Score) to assess response to study intervention","12 Years",{"count":277,"type":22},882,[196],"The purpose of this protocol is to evaluate the efficacy (how well it works), safety and tolerability of oral icotrokinra as therapy in adult and adolescent participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops tiny open ulcers).",[58],{"date":140,"type":34},{"date":283,"type":34},"2025-10-01",{"date":285,"type":22},"2032-01-13",{"name":206,"class":41},400,{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":17,"minAge":296,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":23,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":310},"100567065","phase-3-a-long-term-extension-lte-study-of-guselkumab-in-pediatric-participants-100567065","NCT06663332","A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants","CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis","TRILOGY","Inclusion Criteria:\n\n* Must have completed the dosing planned in the primary pediatric guselkumab study\n* Must have received benefit from continued guselkumab therapy in the opinion of the investigator\n* Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure\n* Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.\n\nExclusion Criteria:\n\n* Participant is greater than or equal to (\\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication\n* Participant is \\\u003C18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication\n* Are pregnant, nursing, or planning pregnancy or fathering a child\n* Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention\n* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments","3 Years",{"count":298,"type":22},196,[196],"The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).",[302,58,223,303],"Crohns Disease","Arthritis, Juvenile",{"date":140,"type":34},{"date":306,"type":34},"2024-10-29",{"date":308,"type":22},"2032-02-25",{"name":206,"class":41},49,{"id":312,"slug":313,"hasResults":12,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":75},"100391063","a-study-to-assess-the-long-term-safety-of-ustekinumab-versus-other-biologics-in-patients-with-crohns-disease-and-ulcerative-colitis-100391063","NCT04372108","A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis","RRA-18896: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database","Inclusion Criteria:\n\n* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period\n* Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs\n\nExclusion Criteria:\n\n* Participants below 18 years of age on the exposure index date\n* Participants who do not meet the definition for CD or UC prior to or on the exposure index date\n* Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \\[NMSC\\]) at any time prior to or on the exposure index date\n* Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date\n* In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded",{"count":319,"type":22},1536,"The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).",[57,58],{"date":140,"type":34},{"date":324,"type":34},"2021-06-24",{"date":326,"type":22},"2030-08-30",{"name":328,"class":41},"Janssen Scientific Affairs, LLC",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":349,"locationsCount":351},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":338,"type":22},645,[25],"This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[29,56,342,58],"Colitis","2026-07-24",{"date":345,"type":34},"2026-07-28",{"date":347,"type":34},"2025-05-27",{"date":71,"type":22},{"name":350,"class":41},"Spyre Therapeutics, Inc.",259,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":359,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":378},"100445110","phase-2-a-study-investigating-oral-ozanimod-rpc1063-in-pediatric-participants-with-moderate-to-severe-active-ulcerative-colitis-100445110","NCT05076175","A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis","A Phase 2\u002F3, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Oral Ozanimod (RPC1063) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis With an Inadequate Response to Conventional Therapy","Inclusion Criteria\n\n* Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit\n* Evidence of UC extending beyond the rectum, as determined by baseline endoscopy\n* Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy\n\nExclusion Criteria\n\n* Diagnosis of Crohn's disease or indeterminate colitis\n* Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool\n* Apheresis within 2 weeks of randomization\n* History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis\n* Other protocol-defined inclusion\u002Fexclusion criteria apply","2 Years","17 Years",{"count":362,"type":22},120,[25,196],"The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.",[58],[29,367,368],"Ozanimod","Pediatric","2026-07-22",{"date":371,"type":34},"2026-07-23",{"date":373,"type":34},"2022-05-30",{"date":375,"type":22},"2032-07-12",{"name":377,"class":41},"Bristol-Myers Squibb",90,{"id":380,"slug":381,"hasResults":12,"nctId":382,"briefTitle":383,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":388,"studyType":158,"phases":4,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":4},"100648302","characterization-of-colorectal-dysplasic-lesions-and-stratification-of-their-evolving-risk-in-inflammatory-bowel-disease-patients-a-prospective-observational-and-multicenter-study-100648302","NCT07719426","Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study","IB DYSPLASIA","Inclusion Criteria:\n\n* Patients age ≥ 18 years\n* Documented diagnosis of CD or UC established based on standard clinical, endoscopic and histological criteria.\n* IBD patients requiring screening colonoscopy for dysplasia as following:\n\n  * IBD (CD\u002FUC) evolving for more than 8 years, or for ≥1 year if associated with Primary Sclerosing Cholangitis (PSC)\n  * For UC: Extended ulcerative colitis (E2 or E3 in the Montreal classification)\n  * For CD: Colonic (L2) or ileocolonic (L3) Crohn's disease with \\> 50% involvement of the colon.\n* Patient affiliated to the health security system\n* Patient who has received information about the study by the investigator and agreed to participate.\n\nExclusion Criteria:\n\n* Patient followed for ileal Crohn's disease (L1)\n* Patient followed for rectal ulcerative colitis (E1)\n* Patient referred for a therapeutic endoscopic procedure, without prior or subsequent follow-up in the participating center\n* Patients \\\u003C 18 years old\n* Patient under guardianship or curatorship\n* Patient objects to their personal data being used in the context of research",{"count":387,"type":22},800,"5 Years","Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1). The incidence of CRC in IBD has gradually declined, attributed to enhanced detection of preneoplastic lesions (dysplasia), improved adherence to screening recommendations, utilization of advanced high-definition endoscopes (2-4), and the implementation of more efficacious therapeutic strategies (5-9).\n\nPresently, there is no consensus on the endoscopic management of dysplastic lesions. Recent techniques such as submucosal dissection (ESD) enable the resection of non-polypoid flat lesions larger than 2 cm. Lesions previously treated with colectomy can now be resected by ESD with en-bloc resection rates of approximately 85.7% (17). However, long-term data on the risk of local or distant recurrence after endoscopic resection in IBD is lacking. It is crucial to evaluate complete (R0) and curative resection rates, as well as the rate of local recurrence, based on the type of endoscopic treatment.\n\nIn light of the 21st century advancements, characterized by high-definition endoscopes and targeted treatments, it is imperative to:\n\n* Assess the prevalence and incidence of dysplasia in IBD and its risk of progression to CRC.\n* Specifically characterize the endoscopy and histology of pre-neoplastic lesions in IBD to facilitate better selection of lesions amenable to endoscopic treatment or surgery.\n* Evaluate the rates of local and distant recurrence over time, considering factors associated with this evolving risk (IBD characteristics, endoscopic appearance, histology, type of resection, etc.).",[391,28],"Crohn Disease (CD)",[393],"All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion","2026-07-17",{"date":369,"type":34},{"date":397,"type":22},"2026-09-15",{"date":399,"type":22},"2033-09-15",{"name":401,"class":74},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":410,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":130},"100615723","phase-2-confirmatory-clinical-study-in-active-ulcerative-colitis-100615723","NCT07296315","Confirmatory Clinical Study in Active Ulcerative Colitis","A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to- Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid","StarFish-UC","Inclusion Criteria:\n\n* Documented diagnosis (histologic diagnosis and either endoscopic or radiographic diagnosis) of ulcerative colitis (UC) at least 3 months prior to Screening.\n* Diagnosis of active mild-to-moderate UC at Screening as defined by an mMS of 4 to 7, including a MES ≥2 (confirmed by central reading), a Mayo Rectal Bleeding score of 1 or 2, and a Mayo Stool Frequency score ≥1.\n* UC lesions extending ≥10 cm from the anal verge.\n* Participant must either receive a stable dose of orally administered 5-aminosalicylic acid (5-ASA); have failed, due to insufficient efficacy, oral 5-ASA; have a documented intolerance or poor tolerance to an aminosalicylic acid treatment, including 5-ASA, or be contra-indicated to receive 5-ASA treatment per local labeling.\n* Participant must provide written informed consent or assent (parent or legal guardian must provide consent for a participant \\\u003C18 years of age who has assented to participate in the study, or as required per local regulations).\n* In countries not allowing females of childbearing potential (FOCBP) to participate without an acceptable contraceptive method, the FOCBP must agree to abide to local requirements and eg, use at least an acceptable method of contraception until the end of treatment.\n\nExclusion Criteria:\n\n* Diagnosis of Crohn's disease, undetermined colitis, ischemic colitis, fulminant colitis, or toxic megacolon.\n* Evidence of a clinically significant, active infection of the gastrointestinal tract.\n* Severe UC (mMS\\>7), meeting modified Truelove Witts' criteria and\u002For RB score of 3, participant with ulcerative proctitis only, or participant in whom colitis is most severe in the transverse colon or ascending colon, or if any hospitalization is planned at the time of Screening.\n* Total colectomy, stoma, or ileo-anal pouch, or history of extensive colonic resection leaving less than 30 cm of colon.\n* Presence of intra-abdominal fistula, abscesses, diverticulitis, or gastrointestinal bleeding unrelated to UC.\n* History of colon carcinoma or high-grade dysplasia.\n* Previous use of any advanced UC treatment, including any anti-TNF (eg, infliximab), antiintegrin (eg, vedolizumab) or anti-IL-12\u002F23 (eg, ustekinumab) agent, anti-IL23 (eg, risankizumab), Janus kinase inhibitors (eg, tofacitinib), and sphingosine-1-phosphate receptor modulators (eg, etrasimod).\n* Use of sulfasalazine ≤4 weeks prior to randomization.\n* Use of corticosteroids or any disease-modifying antirheumatic drugs (DMARD), including thiopurines, ≤6 weeks prior to randomization into the study, except for a stable, low dose of oral corticosteroids (≤10 mg prednisolone\u002Fday) for at least 2 weeks prior to Screening colonoscopy and up to at least the Week 12 visit.\n* Use of antibiotics (except for local use), prebiotics, or probiotics ≤4 weeks prior to randomization or anticipated during study participation, or concomitant, chronic use of an antidiarrheal drug, or concomitant use of any rectal treatment.\n* Use of fecal microbiota transplantation (FMT) ≤52 weeks prior to randomization.\n* Treatment with another investigational drug or intervention within 30 days prior to Screening, or within 5 times the elimination half-life of the investigational drug (whichever is longest).\n* Any immunocompromised state, including conditions linked to severe immunosuppression (eg, active human immunodeficiency virus, malignancies, liver cirrhosis, systemic chemotherapy).\n* Leukopenia (total white blood cell count \\\u003C3000\u002FμL) and\u002For neutropenia (absolute neutrophil count \\\u003C1000\u002FμL), anemia (hemoglobin \\\u003C10.0 g\u002FdL), thrombocytopenia (peripheral blood platelet count \\\u003C100 × 10\\^9\u002FL), and\u002For any coagulation disorder with significantly increased risk of bleeding.\n* Ongoing or recent (\\\u003C3 months) renal disease or insufficiency as manifested, eg, by medical history and\u002For clinical examination and\u002For (calculated or measured) glomerular filtration rate ≤60 mL\u002Fmin.\n* Ongoing or recent (\\\u003C3 months) advanced hepatic dysfunction defined as a Child Pugh score ≥10 (Class C), or increase ≥2 times the upper limit of normal in aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) or international normalised ratio (INR).\n* Clinically significant bone marrow disease if progressive or not controlled, or any history of solid organ or bone marrow transplantation.\n* Active intravenous drug abuse or alcohol abuse disorder as assessed by the Investigator.\n* Pregnancy or lactation at study entry. Note: Participants who become pregnant or start to breastfeed during the study may continue the study per the Investigator's discretion.\n* Participants who are inappropriate for the study per the Investigator's discretion.\n* An employee (or a relative of) of the Investigator, study center, contract research organization, or Sponsor.","16 Years",{"count":412,"type":22},204,[25],"The main goal of the study is to check if MH002 works and is safe to use. In a previous study in 45 patients with Ulcerative Colitis, MH002 was found to have favorable effects. In this study, 2 different doses will be tested, and long-term treatment effects will be investigated.\n\nMH002 is a live biotherapeutic product (LBP). This is a biological medicine containing live bacteria used to restore the normal function of a gut that is damaged by ulcerative colitis (UC). Ulcerative colitis is a bowel disease that causes inflammation and sores in the gut.",[58],[417,418,419],"5-aminosalicylic-acid","live biotherapeutic product","ulcerative colitis","2026-07-07",{"date":422,"type":34},"2026-07-09",{"date":424,"type":34},"2026-04-03",{"date":426,"type":22},"2028-05",{"name":428,"class":41},"MRM Health NV",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":440,"conditions":441,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":442,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":42},"100546721","an-observational-study-of-etrasimod-in-adult-patients-with-moderate-to-severe-ulcerative-colitis-100546721","NCT06398626","An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis","A Multi-Center, Prospective, Non-Interventional Study of Real-World Effectiveness of Etrasimod in Patients With Ulcerative Colitis (ENDEAVOUR-UC)","ENDEAVOUR-UC","Inclusion Criteria:\n\n1. Age ≥ 18 years and \\\u003C 65 years at baseline\n2. Patients with confirmed diagnosis of UC who are prescribed etrasimod for moderately to severely active UC\n3. Evidence of a personally signed and dated ICD indicating that the patient (or a legally acceptable representative)has been informed of all pertinent aspects of the study\n\nExclusion Criteria:\n\n1. The presence of clinical findings suggestive of Crohn's disease\n2. Severe extensive colitis evidenced by:\n\n   1. Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (e.g., colectomy) within 12 weeks\n   2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon\n3. Patients with a stoma or planned UC surgical intervention requiring hospitalization\n4. Prior\u002FConcomitant Therapy:\n\n   1. Any previous exposure to etrasimod, including participation in the etrasimod clinical program\n   2. Any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine, or tioguanine)\n   3. Any co-medication with one of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist; JAKi \\[filgotinib, tofacitinib, or upadacitinib\\]) or with any other S1P receptor modulator\n5. Unwillingness or inability to download the web-based tool to complete ePROs on a personal device or not capable of using the web-based tool\n6. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family","64 Years",{"count":439,"type":22},300,"The purpose of this observational study is to learn about the effects of etrasimod as a treatment for adult patients with moderate to severe ulcerative colitis. Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment of choice according to the physician and they have not previously taken etrasimod.\n\nAll patients will be prescribed etrasimod according to standard of care. Tests and doctor visits will be conducted according to standard of care with the exception of health questionnaires about ulcerative colitis symptoms. These questionnaires will be completed by patients at various timepoints during the study using their mobile phone, tablet, or computer.\n\nThe study is 52 weeks with 28 days of safety follow up. The effects of etrasimod will be analyzed for each patient comparing their disease activity prior to the start of etrasimod.",[58],{"date":422,"type":34},{"date":444,"type":34},"2024-09-17",{"date":446,"type":22},"2028-07-07",{"name":448,"class":41},"Pfizer",{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":459,"conditions":460,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":75},"100611566","a-study-to-observe-real-world-evidence-of-guselkumab-treatment-in-participants-with-ulcerative-colitis-and-crohns-disease-in-the-united-kingdom-uk-100611566","NCT07242248","A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)","Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK","GUSTO-UK","Inclusion Criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of the drug. Decision to prescribe must solely be made by the treating physician in line with the Trust's\u002F Health Board's treatment guidance. Enrolment must take place before or at the day of first administration (but after treatment decision by physician)\n* Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records\n* Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion Criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included\n* Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and \u002For small molecules)\n* Is unable to provide informed consent",{"count":458,"type":22},220,"The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. CD and UC are the main type of Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[461,58,462],"Inflammatory Bowel Disease","Crohn's Disease","2026-07-02",{"date":465,"type":34},"2026-07-06",{"date":467,"type":34},"2025-11-17",{"date":469,"type":22},"2029-03-17",{"name":471,"class":41},"Janssen-Cilag Ltd.",{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":478,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":482,"conditions":483,"keywords":484,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":75},"100600813","a-study-to-generate-real-world-evidence-of-guselkumab-effectiveness-in-inflammatory-bowel-disease-in-germany-100600813","NCT07102368","A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany","Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects","GORGEOUS","Inclusion Criteria:\n\n1. Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics\n2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements\n3. By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study\n\nExclusion Criteria:\n\n1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy\n2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included\n3. Has had a colectomy and\u002For a pouch\n4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \\& Johnson (J\\&J)",{"count":481,"type":22},500,"The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.",[461,58,462],[61,29,462,485,139,486,487,488,489,56,58,490,491,492,493],"Gastroenteritis","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Pathologic Processes","Ulcer","Guselkumab","Tremfya","Inflammatory",{"date":465,"type":34},{"date":496,"type":34},"2025-08-18",{"date":498,"type":22},"2029-01-15",{"name":500,"class":41},"Janssen-Cilag G.m.b.H",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":510,"conditions":511,"keywords":513,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":525},"100534999","a-study-of-jyseleca-tablet-filgotinib-maleate-in-korean-participants-100534999","NCT06246123","A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants","Post Marketing Surveillance of Jyseleca Tab. (Filgotinib Maleate) in Korean Subjects","Inclusion Criteria:\n\n1\\. Individuals who are being administered with Jyseleca tablet in accordance with the Korean approved label therapeutic indications.\n\n* Korean local label therapeutic indications of Jyseleca tablet. In the following participants, Jyseleca tablet should be used only if they do not respond appropriately or are intolerant to existing treatments.\n* Following:\n\n  1. Participants over 65 years of age.\n  2. Participants with a high cardiovascular risk.\n  3. Participants with malignancy.\n* Rheumatoid arthritis:\n\n  1. For treatment of moderately to severely active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).\n  2. Jyseleca tablet may be used as monotherapy or in combination with methotrexate (MTX).\n  3. Jyseleca tablet should not be used in combination with biological DMARDs (bDMARDs) or other Janus kinase (JAK) inhibitors.\n* Ulcerative colitis:\n\n  a. For treatment of moderately to severely active ulcerative colitis in adults who have an inadequate response with, lost response to, or were intolerant to either conventional therapy (corticosteroids, immunosuppressants, etc.) or biological agents.\n* The investigator should refer to local label and contraindications in Korea regarding the inclusion criteria.\n\nExclusion Criteria:\n\n1. Individuals who fall under contraindications to the administration of Jyseleca tablet in accordance with the local label by the medical judgment of the investigator.\n\n   * Contraindication for Jyseleca tablet in accordance with the Korean label:\n\n     1. Participants with hypersensitivity to the active ingredient or other ingredients of the Jyseleca tablet.\n     2. Participants with active infections, including serious (example, sepsis) or local infections.\n     3. Participants with active tuberculosis.\n     4. Participants with severe hepatic disorder.\n     5. Participants with end-stage renal disorder.\n     6. Participants with absolute neutrophil count (ANC) \\\u003C1\\*10\\^9 cells\u002Fliters (L)\n     7. Participants with absolute lymphocyte count (ALC) \\\u003C0.5\\*10\\^9 cells\u002FL\n     8. Participants with hemoglobin level \\\u003C8 grams per deciliter (g\u002FdL)\n     9. Pregnant or potentially pregnant women, lactating women\n     10. Jyseleca tablet should not be administered to participants with genetic problems such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption as it contains lactose.\n2. Individuals who are administered Filgotinib in a clinical study other than this post marketing surveillance.\n3. Individuals who are considered incompatible with participate in this surveillance by the medical judgment of the investigator.\n\n   * The investigator should refer to local label and contraindications in Korea regarding the exclusion criteria.",{"count":509,"type":22},2040,"The purpose of this study is to collect and evaluate the following information in relation to the safety and the efficacy of Jyseleca tablet (Filgotinib Maleate) 100 milligram (mg) and 200 mg in this post marketing setting: (1) Serious adverse events and adverse drug reactions (2) Unexpected adverse events and adverse drug reactions not reflected in precautions for use (3) Known adverse drug reactions (4) Non-serious adverse events and adverse drug reactions (5) Other safety and effectiveness related information will be evaluated in accordance with the permitted articles under the actual conditions of use in Korea.",[512,58],"Arthritis, Rheumatoid",[514,515,516,517],"Filgotinib Maleate","Rheumatoid arthritis","Ulcerative colitis","FIL-M082-501",{"date":465,"type":34},{"date":520,"type":34},"2024-02-27",{"date":522,"type":22},"2027-07-30",{"name":524,"class":41},"Eisai Korea Inc.",59,{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":4},"100645383","retrospective-observational-multicenter-study-on-the-treatment-patterns-extra-intestinal-manifestations-resource-utilisation-and-outcomes-of-patients-with-inflammatory-bowel-disease-in-dutch-hospitals-100645383","NCT07682038","Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals","Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals","Inclusion Criteria:\n\n* Adult patients (≥18 years of age) who required secondary (hospital) care after January 2018 with a confirmed diagnosis of CD or UC, defined by at least one ICD-10 diagnosis code for CD or UC (K50, K51, K52).\n\nIndex date confirmation: the index date is defined as the first date of confirmed CD or UC diagnosis, requiring at least one healthcare encounter for CD or UC AND at least one prescription or dispensing record for any CD or UC-related medication within the observational period.\n\nExclusion Criteria:\n\n* Patients who have formally objected to the use of their hospital data for scientific research purposes. Objections are recorded by the treating hospital in the DBC administrative system and automatically transferred to the research dataset, ensuring automatic exclusion from all analyses.",{"count":534,"type":22},3500,"This multicenter retrospective real-world data study will evaluate the treatment pathways and disease burden of adult patients with Crohn's disease (CD) and ulcerative colitis (UC) treated in 5-10 Dutch hospitals between 2018 and 2026.\n\nThe study will assess:\n\n* Treatment sequences, switching patterns, and treatment duration\n* Prevalence and incidence of extra-intestinal manifestations (EIMs)\n* Healthcare resource utilization (hospitalizations, outpatient visits, endoscopies, surgery, and length of stay)\n* Direct healthcare costs\n* Availability of disease activity biomarkers\n\nUsing linked administrative, prescription, procedure, and laboratory data, outcomes will be analyzed by age, line of therapy, and clinical characteristics. Special focus will be placed on the impact of EIMs on treatment patterns, healthcare utilization, and costs.\n\nThe findings will provide real-world evidence on IBD management in the Netherlands and support clinical decision-making, healthcare planning, and future research on treatment optimization and coexisting immune-mediated conditions.",[57,537,28],"Inflammatory Bowel Disease (IBD)","2026-06-26",{"date":463,"type":34},{"date":541,"type":22},"2026-08-01",{"date":543,"type":22},"2027-06-30",{"name":545,"class":41},"LOGEX",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":552,"eligibilityCriteria":553,"healthyVolunteers":12,"sex":17,"minAge":359,"maxAge":554,"enrollmentInfo":555,"targetDuration":4,"studyType":23,"phases":557,"briefSummary":558,"conditions":559,"keywords":560,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":7},"100629148","phase-2-a-study-of-how-the-medicine-called-etrasimod-works-in-children-with-the-gut-disease-called-ulcerative-colitis-100629148","NCT07470879","A Study of How the Medicine Called \"Etrasimod\" Works in Children With the Gut Disease Called Ulcerative Colitis","A PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS","ELEVATE-UCkids","Inclusion criteria:\n\nHave a diagnosis of ulcerative colitis (UC) that is moderately to severely active Participants are permitted to be receiving a therapeutic dose of select UC therapies\n\nExclusion criteria:\n\nSevere extensive colitis Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis","11 Years",{"count":556,"type":22},24,[25],"The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to \\\u003C 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).",[58],[561,562,419,563,564],"ulcerative","colitis","etrasimod","pediatrics","2026-06-23",{"date":538,"type":34},{"date":568,"type":34},"2026-05-28",{"date":570,"type":22},"2034-08-18",{"name":448,"class":41},{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":12,"sex":17,"minAge":580,"maxAge":360,"enrollmentInfo":581,"targetDuration":4,"studyType":158,"phases":4,"briefSummary":583,"conditions":584,"keywords":586,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":75},"100644630","resting-energy-expenditure-in-pediatric-patients-with-inflammatory-bowel-disease-ree-mici-100644630","NCT07670975","Resting Energy Expenditure in Pediatric Patients With Inflammatory Bowel Disease (REE-MICI)","Measurement of Basal Metabolism in Patients With Crohn's Disease and Ulcerative Colitis and Correlation With Disease Activity.","REE-MICI","Inclusion Criteria:\n\n* Pediatric patients aged 6 to 17 years\n* New diagnosis of inflammatory bowel disease, including Crohn disease or ulcerative colitis, according to ECCO\u002FESPGHAN criteria\n* Written informed consent signed by parents or legal guardians\n\nExclusion Criteria:\n\n* Intestinal surgery within 6 weeks before the first evaluation\n* Parenteral or enteral nutrition within 6 weeks before the first evaluation\n* Eating disorders or other chronic diseases associated with possible malabsorption","6 Years",{"count":582,"type":22},50,"This multicenter prospective observational non-pharmacological study aims to evaluate resting energy expenditure (REE) in pediatric patients affected by inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. REE will be measured using indirect calorimetry and estimated using predictive equations. The study also aims to investigate the relationship between REE, disease activity, and dietary or pharmacological treatments. Clinical, laboratory, anthropometric, nutritional, and disease activity data will be collected during routine clinical follow-up at diagnosis, after induction therapy, and during follow-up visits.",[585,58,56],"Crohn Disease Colitis",[587,588,589,590,591,592,593],"Energy Metabolism","Calorimetry, Indirect","Malnutrition","Pediatric Obesity","Nutritional Status","Child","Disease Activity","2026-06-22",{"date":538,"type":34},{"date":597,"type":34},"2025-05-01",{"date":599,"type":22},"2027-11",{"name":601,"class":74},"Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria"]