[{"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":81},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,37,0,25,[9,43,66,91,120,153,179,200,227,251,271,296,320,342,361,381,401,432,453,474,501,521,541,562,581],{"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","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2026-03-24",{"date":38,"type":22},"2028-12-21",{"name":40,"class":41},"Merck Sharp & Dohme LLC","INDUSTRY",11,{"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":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"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":51,"type":22},3500,"OBSERVATIONAL","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.",[55,56,28],"Crohn Disease","Inflammatory Bowel Disease (IBD)","NOT_YET_RECRUITING","2026-06-26",{"date":33,"type":34},{"date":61,"type":22},"2026-08-01",{"date":63,"type":22},"2027-06-30",{"name":65,"class":41},"LOGEX",{"id":67,"slug":68,"hasResults":12,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"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":75,"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.",[29,79,80,81],"Inflammatory Bowel Diseases","Colitis","Colitis, Ulcerative",{"date":83,"type":34},"2026-06-29",{"date":85,"type":34},"2025-05-27",{"date":87,"type":22},"2028-03",{"name":89,"class":41},"Spyre Therapeutics, Inc.",243,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":17,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"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","2 Years","11 Years",{"count":102,"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).",[81],[107,108,109,110,111],"ulcerative","colitis","ulcerative colitis","etrasimod","pediatrics","2026-06-23",{"date":58,"type":34},{"date":115,"type":34},"2026-05-28",{"date":117,"type":22},"2034-08-18",{"name":119,"class":41},"Pfizer",{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"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","17 Years",{"count":131,"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.",[134,81,79],"Crohn Disease Colitis",[136,137,138,139,140,141,142],"Energy Metabolism","Calorimetry, Indirect","Malnutrition","Pediatric Obesity","Nutritional Status","Child","Disease Activity","2026-06-22",{"date":58,"type":34},{"date":146,"type":34},"2025-05-01",{"date":148,"type":22},"2027-11",{"name":150,"class":151},"Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria","OTHER",1,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":17,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":23,"phases":164,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":178},"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":163,"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.",[81],[168,169,109],"5-aminosalicylic-acid","live biotherapeutic product",{"date":171,"type":34},"2026-06-25",{"date":173,"type":34},"2026-04-03",{"date":175,"type":22},"2028-05",{"name":177,"class":41},"MRM Health NV",14,{"id":180,"slug":181,"hasResults":12,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":187,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100582729","phase-2-a-study-to-investigate-efficacy-and-safety-of-sar441566-in-patients-with-ulcerative-colitis-100582729","NCT06867094","A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis","A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR441566 in Adults With Moderate-to-severe Ulcerative Colitis","SPECIFI-UC","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent\n* Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period\n* Active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician global Assessment (PGA), with a minimum rectal bleeding (RB) subscore ≥1, a minimum stool frequency (SF) subscore ≥1, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent \\>15 cm from the anal verge\n* Must have received prior treatment for UC (either \"a\" or \"b\" below or a combination of both \"a\" and \"b\"):\n\n  1. History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR\n  2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12\u002F23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for UC\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Participants with active CD, indeterminate colitis, ischemic colitis, microscopic colitis\n* Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study\n* Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study\n* Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools\n* Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines\n* Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and\u002For hepatitis C virus antibody (HCVAb) at the screening visit\n* Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex\n* Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening\n* Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening\n* History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit.\n* If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \\>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded.\n* Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug\n* Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral\u002Fintramuscular anti-infectives within 14 days prior to the screening visit\n* Participants requiring or receiving any parental nutrition and\u002For exclusive enteral nutrition\n* Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening\n* Participants who received fecal microbial transplantation within 30 days prior to screening\n* Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®)\n* Participants who received IV corticosteroids within 14 days prior to screening or during screening period\n* Screening laboratory and other analyses show abnormal results.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":163,"type":22},[25],"This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis.\n\nThis study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment.\n\nAdditionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study).\n\n* The study duration will be up to 59 weeks.\n* The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm.\n* The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.",[28],"2026-06-19",{"date":112,"type":34},{"date":194,"type":34},"2025-03-28",{"date":196,"type":22},"2028-05-11",{"name":198,"class":41},"Sanofi",115,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":226},"100538752","a-study-to-learn-about-the-effectiveness-of-etrasimod-in-people-with-ulcerative-colitis-100538752","NCT06294925","A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis","Effectiveness of Etrasimod on Disease Activity and Patient-reported Outcomes in Ulcerative Colitis - EFFECT-UC","EFFECT-UC","Inclusion Criteria:\n\n* Male and female patients ≥18 and \\\u003C65 years of age at baseline\n* Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study.\n* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Presence of clinical findings suggestive of Crohn's disease.\n* 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 (eg, colectomy) within 12 weeks.\n  2. Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization.\n\n     4\\. Prior\u002FConcomitant Therapy:\n\n  \u003C!-- -->\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) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator.\n* Not owning a digital device with internet connection and\u002For not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool.\n* 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":210,"type":22},360,"The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.\n\nPatients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.\n\nAll patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.\n\nThe study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.\n\nThe effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.",[81],[214,215,216,217,218],"patient related outcomes","real world data","S1P modulator","Symptomatic Remission","Corticosteroid free symptomatic remission","2026-06-17",{"date":143,"type":34},{"date":222,"type":34},"2024-05-08",{"date":224,"type":22},"2026-06-30",{"name":119,"class":41},38,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":234,"minAge":18,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":23,"phases":237,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":152},"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":236,"type":22},10,[238],"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.",[241,81,55,242],"Psoriasis","Arthritis, Psoriatic","2026-06-12",{"date":219,"type":34},{"date":246,"type":22},"2026-06-15",{"date":248,"type":22},"2027-08-31",{"name":250,"class":41},"Janssen Research & Development, LLC",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":152},"100633863","a-study-to-assess-real-world-outcomes-for-long-term-use-of-guselkumab-100633863","NCT07532213","A Study to Assess Real-world Outcomes for Long-Term Use of Guselkumab","Long-Term Use of Guselkumab: Non-interventional Assessment of Real-world Outcomes","LUNAR","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 (but after treatment decision by physician)\n* Must have 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":131,"type":22},"The purpose of this study is to evaluate how long guselkumab remains in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[262,81,55],"Inflammatory Bowel Disease","2026-06-10",{"date":243,"type":34},{"date":266,"type":34},"2026-04-13",{"date":268,"type":22},"2029-04-10",{"name":270,"class":41},"Janssen-Cilag A.G., Switzerland",{"id":272,"slug":273,"hasResults":12,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":12,"sex":17,"minAge":99,"maxAge":129,"enrollmentInfo":278,"targetDuration":4,"studyType":23,"phases":280,"briefSummary":282,"conditions":283,"keywords":284,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"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",{"count":279,"type":22},120,[25,281],"PHASE3","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.",[81],[29,285,286],"Ozanimod","Pediatric",{"date":288,"type":34},"2026-06-11",{"date":290,"type":34},"2022-05-30",{"date":292,"type":22},"2032-07-12",{"name":294,"class":41},"Bristol-Myers Squibb",90,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":17,"minAge":304,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},"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":306,"type":22},196,[281],"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).",[310,81,242,311],"Crohns Disease","Arthritis, Juvenile","2026-06-09",{"date":288,"type":34},{"date":315,"type":34},"2024-10-29",{"date":317,"type":22},"2032-02-25",{"name":250,"class":41},47,{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},"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":329,"type":22},644,[281],"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).",[81],"2026-06-04",{"date":335,"type":34},"2026-06-08",{"date":337,"type":34},"2026-05-23",{"date":339,"type":22},"2030-10-30",{"name":250,"class":41},6,{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"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":351,"type":22},35,"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.",[55,81],{"date":355,"type":34},"2026-06-05",{"date":246,"type":22},{"date":358,"type":22},"2029-06-15",{"name":360,"class":41},"Janssen-Cilag Pharma GmbH",{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":380},"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":370,"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.",[81],{"date":355,"type":34},{"date":375,"type":34},"2025-12-11",{"date":377,"type":22},"2028-06-30",{"name":379,"class":41},"Xian-Janssen Pharmaceutical Ltd.",9,{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":387,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":152},"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":390,"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.",[262,81,393],"Crohn's Disease",{"date":355,"type":34},{"date":396,"type":34},"2025-11-17",{"date":398,"type":22},"2029-03-17",{"name":400,"class":41},"Janssen-Cilag Ltd.",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":411,"conditions":412,"keywords":413,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":152},"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":410,"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.",[262,81,393],[414,29,393,415,416,417,418,419,420,79,81,421,422,423,424],"IBD","Gastroenteritis","Gastrointestinal Diseases","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Pathologic Processes","Ulcer","Guselkumab","Tremfya","Inflammatory",{"date":355,"type":34},{"date":427,"type":34},"2025-08-18",{"date":429,"type":22},"2029-01-15",{"name":431,"class":41},"Janssen-Cilag G.m.b.H",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":438,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":440,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":23,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},"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":442,"type":22},882,[281],"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).",[81],{"date":355,"type":34},{"date":448,"type":34},"2025-10-01",{"date":450,"type":22},"2032-01-13",{"name":250,"class":41},393,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":460,"enrollmentInfo":461,"targetDuration":4,"studyType":23,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":468,"completionDateStruct":470,"leadSponsor":471,"locationsCount":473},"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":462,"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.",[81,55],"2026-06-03",{"date":333,"type":34},{"date":469,"type":34},"2026-05-04",{"date":87,"type":22},{"name":472,"class":41},"Eli Lilly and Company",72,{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":500},"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":482,"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.",[485,81],"Arthritis, Rheumatoid",[487,488,489,490],"Filgotinib Maleate","Rheumatoid arthritis","Ulcerative colitis","FIL-M082-501","2026-05-21",{"date":493,"type":34},"2026-05-22",{"date":495,"type":34},"2024-02-27",{"date":497,"type":22},"2027-07-30",{"name":499,"class":41},"Eisai Korea Inc.",65,{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":23,"phases":510,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":5},"100566138","phase-3-extension-study-of-long-term-safety-and-efficacy-of-tulisokibart-in-participants-with-crohns-disease-or-ulcerative-colitis-mk-7240-011-100566138","NCT06651281","Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)","A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis","Inclusion Criteria:\n\n* Has participated in a qualifying tulisokibart Phase 2 or Phase 3 parent study for CD or UC\n* The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study\n* A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention\n* A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention\n* A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)\n\nExclusion Criteria:\n\n* Has prematurely discontinued study intervention in their parent study\n* Has received any protocol-specified prohibited medications during their parent study\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients",{"count":509,"type":22},1380,[281],"Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.",[55,81],"2026-05-15",{"date":515,"type":34},"2026-05-19",{"date":517,"type":34},"2024-11-25",{"date":519,"type":22},"2037-12-17",{"name":40,"class":41},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":530,"conditions":531,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":152},"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","An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: 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":529,"type":22},1056,"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).",[55,81],"2026-05-07",{"date":534,"type":34},"2026-05-08",{"date":536,"type":34},"2021-06-24",{"date":538,"type":22},"2030-08-30",{"name":540,"class":41},"Janssen Scientific Affairs, LLC",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":549,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":551,"conditions":552,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":556,"completionDateStruct":558,"leadSponsor":560,"locationsCount":561},"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",{"count":550,"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.",[81],"2026-04-23",{"date":555,"type":34},"2026-04-28",{"date":557,"type":34},"2024-09-17",{"date":559,"type":22},"2028-07-07",{"name":119,"class":41},22,{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":128,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":152},"100521102","therapeutic-endpoint-in-pediatric-ibd-conditions-100521102","NCT06065228","Therapeutic Endpoint in Pediatric IBD Conditions","Development of a Therapeutic Endpoint in Pediatric IBD Conditions","Inclusion Criteria:\n\n* Male or female ≥ 6 years of age at screening.\n* Documentation of an IBD diagnosis as evidenced by history\n\nExclusion Criteria:\n\n* Documented history of eye disease precluding pupillometry\n* Patients who are unwilling or unable to participate due to developmental delays or ongoing psychological diagnoses.","21 Years",{"count":462,"type":22},"The purpose of this clinical study is the development of physiologic endpoint of inflammation in pediatric patients diagnosed with inflammatory bowel disease (IBD), specifically subtypes Crohn's disease (CD) and ulcerative colitis (UC). The novel medical device evaluates the patient's sensory response to each of the three sensory nerve fiber types. Data from the device provides an assessment of disease activity and a more precise approach to treatment.",[79,81,55],{"date":574,"type":34},"2026-04-08",{"date":576,"type":34},"2023-11-27",{"date":578,"type":22},"2027-12",{"name":580,"class":151},"Children's National Research Institute",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":23,"phases":589,"briefSummary":591,"conditions":592,"keywords":596,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":152},"100622161","acceptability-adherence-and-impact-on-the-bioavailability-of-iron-and-zinc-of-the-dietary-supplements-goodphyte-ib-defense-and-goodphyte-immunity-in-adults-with-chronic-diseases-100622161","NCT07380022","Acceptability, Adherence, and Impact on the Bioavailability of Iron and Zinc of the Dietary Supplements Goodphyte IB Defense and Goodphyte Immunity in Adults With Chronic Diseases.","PHYTASE","Inclusion Criteria:\n\n* Crohn's disease: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.\n* Ulcerative colitis: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.\n* Hypertension: Patients with systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg, who maintain blood pressure within these ranges through lifestyle modifications, without active symptoms (e.g., headaches, dizziness), and not receiving antihypertensive medication.\n* Anemia: Patients with hemoglobin \\\u003C12 g\u002FdL, serum iron \\\u003C40 μg\u002FdL, and ferritin \\\u003C15 ng\u002FmL for women, and hemoglobin \\\u003C13 g\u002FdL, serum iron \\\u003C40 μg\u002FdL, and ferritin \\\u003C30 ng\u002FmL for men. Absence of severe clinical consequences. Presence of fatigue, weakness, or dizziness, which is usually manageable.\n* Multiple sclerosis: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Current use of antibiotics or antibiotic use within the past month\n* Current use of other probiotic, prebiotic, or synbiotic supplements\n* Current use of iron and\u002For zinc supplements\n* Change in the type of therapeutic regimen (pharmacotherapy) within the past three months\n* Change in the dosage of the therapeutic regimen (pharmacotherapy) within the past month\n* Renal or hepatic disease\n* Inability to provide informed consent (including individuals \\\u003C18 years of age)\n* Insufficient understanding of the Greek language",{"count":21,"type":22},[590],"NA","The primary objective of the present postdoctoral research is to evaluate the acceptability and adherence of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity, in adult individuals with chronic diseases, namely Idiopathic Inflammatory Bowel Diseases (IIBD)-that is, Crohn's disease (CD) or Ulcerative Colitis (UC)-Arterial Hypertension (AH), Anemia (AN), or Multiple Sclerosis (MS).\n\nSecondarily, this study will investigate potential changes in iron and zinc absorption following phytase supplementation in these individuals and, consequently, possible changes in their quality of life.",[414,593,594,595,28],"Hypertension (HTN)","Multiple Sclerosis","Anemia",[597,598,586],"ACCEPTABILITY","DIETARY SUPPLEMENT","2026-01-23",{"date":601,"type":34},"2026-02-02",{"date":603,"type":34},"2025-07-09",{"date":605,"type":22},"2026-02-28",{"name":607,"class":151},"University of Thessaly"]