[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis-uc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis-uc":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,103,0,25,[9,45,71,100,125,149,176,198,225,245,265,290,313,337,357,377,401,428,454,477,498,519,547,568,605],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100624854","phase-2-ly4268989-in-adults-with-moderately-to-severely-active-ulcerative-colitis-100624854",false,"NCT07415044","LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis","A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis (EMERALD-3)","EMERALD-3","Inclusion Criteria:\n\n* Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC\n* Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1\n* Have evidence of UC extending proximal to the rectum\n* Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators). Participants with inadequate response to vedolizumab are excluded\n* Must meet contraception requirements\n\nExclusion Criteria:\n\n* Have a current diagnosis of\n\n  * Crohn's disease\n  * Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or\n  * primary sclerosing cholangitis\n* Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation\n* Have had or will need bowel resection or intestinal or intra-abdominal surgery\n* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic\n* Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies\n* Have a diagnosis or history of malignant disease within 5 years prior to randomization","ALL","18 Years","80 Years",{"count":22,"type":23},1431,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The main purpose of this study is to evaluate the safety and effectiveness of LY4268989 when compared to placebo in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.\n\nThe study will last up to approximately 108 weeks, excluding screening.",[29,30,31],"Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate","Ulcerative Colitis, Active Severe","RECRUITING","2026-08-20",{"date":35,"type":36},"2026-08-21","ACTUAL",{"date":38,"type":36},"2026-03-26",{"date":40,"type":23},"2031-07",{"name":42,"class":43},"Eli Lilly and Company","INDUSTRY",259,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100651130","phase-4-the-efficacy-of-lactobacillous-probiotic-and-trace-elements-in-the-management-of-ulcerative-colitis-patients-the-patient-will-be-recruited-from-outpatient-clinic-of-ibd-and-gastroenterology-of-the-national-hepatology-and-tropical-medicine-research-institute-nhtmri-cairo-egypt-100651130","NCT07758335","The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients the Patients Will be Recruited From Outpatient Clinic of Inflammatory Bowel Disease (IBD) of the National Hepatology and Tropical Medicine Research Institute NHTMRI, Cairo, Egypt","The Efficacy of Lactobacillous Probiotic and Trace Elements in the Management of Ulcerative Colitis Patients","Inclusion Criteria:\n\n1. Age 18-65 years.\n2. Patients diagnosed with mild to moderate UC (according to Mayo Score (36) for Ulcerative Colitis).\n3. Patients are on standard of care (biological therapy e.g., infliximab ).\n\nExclusion Criteria:\n\n1. Patients with neurological problems including Alzheimer disease and other dementias, multiple sclerosis, Parkinson's disease, history of large stroke, severe psychiatric disease as it may affect their ability to adhere to their medication and the clinical trial rules and their ability to perform the tests and questionnaires involved in the study (37).\n2. Patients with communication problems, that can affect their ability to fully understand the purpose of the trial, difficulty in communicating by phone or ability to come in scheduled visits (38).\n3. Patients with autoimmune diseases.\n4. Patients with colorectal cancer.\n5. Patients previously received probiotics or trace elements in the previous month before recruitment.\n6. Liver cirrhosis.\n7. Chronic kidney disease (CKD) which is defined as an estimated glomerular filtration rate (eGFR) less than 60 ml\u002Fmin per 1.73 m2, persisting for 3 months or more (39).\n8. Pregnancy or Lactation (40)\n9. Patients on conventional therapy (5-amino salicylic acid treatment).","65 Years",{"count":54,"type":23},132,[56],"PHASE4","the goal of this interventional observational study is to To evaluate the efficacy , safety of lactobacillus probiotics or trace elements when added to (ulcerative colitis) infliximab in maintaining remission in UC patients and to To compare the efficacy of adding lactobacillus probiotics versus adding trace elements to infliximab This study will be open label, parallel, prospective interventional study which will be conducted in the outpatient clinic of IBD and gastroenterology of the National Hepatology and tropical medicine research institute (NHTMRI), Cairo, Egypt.\n\nThe recruited patients will be randomly allocated in one of three groups:\n\nGroup I. Study group 1 will receive 20 billion colony forming unit (CFU) of Lactobacillus acidophilus for six months together with infliximab for 6 months Group II. Study group 2 will receive 1 tablet twice daily of trace elements as Vitayami together infliximab fpr six months Group III. Control group will receive infliximab only without receiving lactobacillus or trace elements.\n\nPrimary outcome The decline in the mayo score to less than 50% after six months compared to baseline.\n\nSecondary outcome The improvement in mucosal healing after six months of intervention measured by colonoscopy compared to baseline.\n\nphysical examination will be done at the baseline then every 2 weeks of the study lab tests will be performed at base line then every 3 months intestinal ultrasound , Colonoscope will be done twice at the beginning and at the end of trial the patients also will be asked to report any adverse events every 2 weeks quality of life of patients will be assed 3 times during trial by Short Irritable Bowel Disease Questionnaire (SIBDQ) , food frequency questionnaire will be done once at the beginning of the study",[29],[60],"ulcerative colitis, remission , lactobacillus, trace elements","2026-08-18",{"date":33,"type":36},{"date":64,"type":36},"2025-07-02",{"date":66,"type":23},"2027-06-01",{"name":68,"class":69},"National Hepatology & Tropical Medicine Research Institute","OTHER_GOV",1,{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":70},"100652339","phase-4-asapp-study---topical-5-asa-as-prophylaxis-for-pouchitis-in-ulcerative-colitis-patients-after-pelvic-pouch-surgery-100652339","NCT07773948","ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery","ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery, a Double Blinded Randomized Controlled Trial","ASAPP","Inclusion Criteria:\n\n* Adult patients with UC who are planned for reconstruction with IPAA. All four Swedish units with a national license to perform restorative surgery in IBD will be recruiting patients.\n\nExclusion Criteria:\n\n* Patients with concomitant primary sclerosing cholangitis (PSC) or previous intolerance to 5-ASA will be excluded.","70 Years",{"count":81,"type":23},110,[56],"Ulcerative colitis (UC) is a chronic intestinal disease, often debuting early in life, and affecting the colon and rectum. The therapy is mainly medical and based on 5-aminosalicylic acid (5-ASA) and steroids. The last 20 years numerous new advanced therapies have become available and introduced more and more early after diagnosis. Surgery is still needed in refractory disease and will cure most patients, while ending up with a stoma. There is conflicting data on whether advanced therapies are decreasing the need for surgery or not.\n\nReconstruction of bowel continuity is usually possible but somehow performed in less than 50% of Swedish patients. Restorative proctectomy with ileal pouch (created of the last part of the small bowel) anal anastomosis (IPAA) is gold standard. As of this year it is centralized to 4 units in Sweden.\n\nOne complication after IPAA is pouchitis, an inflammation in the pouch that behaves like UC. More than half of all patients will have at least one flare of pouchitis, and some will develop chronic or recurrent pouchitis. Recent publications have shown an increased risk of pouchitis after the introduction of advanced therapies, but the reasons for this are still unknown. Prophylactic therapy with 5-ASA after IPAA surgery have been suggested.\n\nAll patients in Sweden going through IPAA surgery due to UC will be invited to be part of this randomized controlled study to evaluate if 5-ASA can diminish the risk of pouchitis in UC.",[29,85],"Pouchitis",[87,88],"Restorative proctocolectomy","Pelvic pouch","NOT_YET_RECRUITING","2026-08-14",{"date":92,"type":36},"2026-08-19",{"date":94,"type":23},"2027-04-01",{"date":96,"type":23},"2031-03-31",{"name":98,"class":99},"University Hospital, Linkoeping","OTHER",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":24,"phases":110,"briefSummary":111,"conditions":112,"keywords":113,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":4},"100650972","a-study-of-ac-101-tablets-in-patients-with-ulcerative-colitis-100650972","NCT07755241","A Study of AC-101 Tablets in Patients With Ulcerative Colitis","A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of AC-101 Tablets in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n1. Male or female participants aged ≥ 18 and ≤ 75 years；\n2. Must sign the Informed Consent Form and be willing to participate in the study.\n3. Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence.\n4. Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥ 2.\n5. Documented failure to prior advanced therapies or prior conventional therapies\n6. Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment:\n\n   1. Female participants of non-childbearing potential;\n   2. Female participants of childbearing potential who are not pregnant must agree to use highly effective contraception during the treatment period and for at least 1 month after the last dose of study treatment;\n   3. Male participants with a pregnant or non-pregnant female partner of childbearing potential must agree to use contraception during the treatment period and for at least 1 month after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Severe extensive colitis.\n2. Hospitalization for exacerbation of UC within 12 weeks prior to screening.\n3. History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy.\n4. Adenomatous colonic polyps that have not been removed prior to study enrollment.\n5. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease.\n6. Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening.\n7. Presence of an ostomy or fistula.\n8. Risk of tuberculosis .\n9. History of current or prior serious opportunistic infection.\n10. Presence of active or chronic recurrent infection.\n11. Patients with any of the following hepatitis B screening results:\n\n    Acute or chronic hepatitis B infection; or Positive hepatitis B virus (HBV) test at screening (HBsAg positive); or HBsAg negative, hepatitis B core antibody (HBcAb) positive, with detectable HBV-DNA.\n12. Current hepatitis C infection, or positive hepatitis C virus (HCV) test at screening.\n13. Human immunodeficiency virus (HIV) infection\u002Facquired immunodeficiency syndrome , or positive HIV antibody test at screening.\n14. Syphilis, or positive syphilis-specific antibody test at screening.\n15. Treatment with advanced therapies for UC within 8 weeks or 5 half-lives prior to randomization.\n16. Treatment with intravenous corticosteroids within 2 weeks prior to randomization.\n17. Treatment with leukocyte apheresis within 12 weeks prior to randomization.\n18. Treatment with intravenous immunoglobulins or plasmapheresis within 12 weeks prior to randomization.\n19. Treatment with lymphocyte-depleting therapy.\n20. History of fecal microbiota transplantation.\n21. Vaccination with live attenuated vaccines within 4 weeks prior to randomization, or a plan to receive such vaccines during the study period.\n22. Requirement for parenteral nutrition.\n23. History of myocardial infarction, acute stroke, transient ischemic attack, thromboembolic events, clinically significant arrhythmia, unstable angina, coronary artery bypass grafting, or severe pulmonary heart disease\u002Fpulmonary hypertension within 3 months prior to randomization, which, in the investigator's judgment, may affect the evaluation of study results.\n24. Presence of any other unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine\u002Fmetabolic, neurological\u002Fpsychiatric, or other medical condition that, in the investigator's judgment, may interfere with the study results.\n25. Known history of immunodeficiency; other acquired or congenital immunodeficiency disorders; or history of organ transplantation.\n26. History of malignancy within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin.\n27. Female patients who are pregnant, lactating, or have a positive serum pregnancy test at screening.\n28. Any other condition that, in the investigator's opinion, may affect the patient's safety or compliance, or preclude the patient from completing the study.","75 Years",{"count":109,"type":23},153,[26],"This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will evaluate the efficacy, safety, and pharmacokinetics of AC-101 compared with placebo in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies. The study consists of a screening period (up to 4 weeks), a 12-week induction period, a 40-week extension period, and a 4-week safety follow-up period.",[29],[114,115,116],"IBD","AC-101","dose finding",{"date":118,"type":36},"2026-08-17",{"date":120,"type":23},"2026-08-28",{"date":122,"type":23},"2028-02-28",{"name":124,"class":43},"Accro Bioscience (Suzhou) Limited",{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":132,"targetDuration":4,"studyType":24,"phases":134,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":141,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100646670","phase-3-study-to-evaluate-the-efficacy-and-safety-of-ponesimod-vsp-128-in-patients-with-moderately-to-severely-active-ulcerative-colitis-100646670","NCT07686081","Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Male and female subjects aged 18-75 years\n* Able to provide written informed consent\n* Diagnosis of ulcerative colitis for ≥90 days prior to screening\n* Three-component Mayo score of 5-9 with endoscopy subscore ≥2 and rectal bleeding subscore ≥1\n* History of inadequate response, loss of response, or intolerance to at least one approved UC therapy\n\nExclusion Criteria:\n\n* Severe or fulminant UC likely to require hospitalization or surgery\n* Diagnosis of Crohn's disease or other non-UC colitis\n* Prior exposure to S1P receptor modulators\n* Active or chronic infections\n* Clinically significant cardiovascular, hepatic, or other uncontrolled systemic disease\n* History of an allergic reaction or significant sensitivity to constituents of study drug",{"count":133,"type":23},150,[135],"PHASE3","A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis",[29],[139,140],"ulcerative colitis","moderately to severely active ulcerative colitis",{"date":61,"type":36},{"date":143,"type":23},"2026-09",{"date":145,"type":23},"2029-08",{"name":147,"class":43},"Vanda Pharmaceuticals",2,{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":18,"minAge":19,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":24,"phases":160,"briefSummary":162,"conditions":163,"keywords":164,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":70},"100650558","phase-1-a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-ono-6414-administered-orally-in-healthy-adult-participants-and-patients-with-active-ulcerative-colitis-100650558","NCT07749768","A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally in Healthy Adult Participants and Patients With Active Ulcerative Colitis","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ONO-6414 Administered Orally as Single Ascending Doses With a Food-Effect Arm and Multiple Ascending Doses in Healthy Adult Participants, and as a Single Dose (Open-Label) in Patients With Active Ulcerative Colitis","●Inclusion Criteria: \\\u003CHealthy Volunteers only\\>\n\n* Male or female, age ≥18- to ≤55-year-old at the time of signing ICF.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, 12-lead ECG, vital signs measurements, and laboratory tests results, as evaluated by the investigator.\n* BMI of 18.0 to 32.0 kg\u002Fm2, inclusive, and a body weight of ≥50 kg at Screening.\n\n\\\u003CPatients only\\>\n\n* Male or female, age ≥18-year-old at the time of signing ICF.\n* A diagnosis of ulcerative colitis (UC) must have been established at least three months prior to screening.\n\n\\\u003CHealthy Volunteers and Patients\\>\n\n* Total abstinence, in accordance with the lifestyle of the participant, from at least 30 days prior to the first dose until at least 90 days after the last dose.\n* Ability to understand the study procedures described in the ICF. Willingness and ability to comply with the protocol, and provides written informed consent prior to study participation.\n* Willingness and ability to swallow study intervention tablets and\u002For suspension.\n* Willing to take off dentures or mouth piercing at the time of dosing.\n\n  ●Exclusion Criteria: \\\u003CHealthy Volunteers only\\>\n* Mentally or legally incapacitated.\n* History or presence of clinically significant medical, surgical or psychiatric condition or disease that in the opinion of the investigator or medical monitor might confound the results of the study or pose an additional risk to the participant by their participation in the study, including but not limited to a history of inflammatory bowel disease, gastritis, ulcers, gastrointestinal or rectal bleeding; history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection or history or clinical evidence of pancreatic injury or pancreatitis, history of cardiac arrhythmia (both atrial and ventricular). History of uncomplicated appendectomy and uncomplicated cholecystectomy are allowed.\n* History of any major invasive surgery within 6 months before the first dosing, or minor invasive surgery within 7 days before the first dosing.\n* History of hypersensitivity or idiosyncratic reaction to the study interventions, excipients (including Lactose) or related compounds, or severe food allergies.\n* History of rare hereditary galactose and\u002For Lactose intolerance (eg, congenital lactase deficiency \\[CLD\\] or glucose-galactose malabsorption \\[GGM\\]).\n* History or presence of alcoholism within 6 months before the first dosing. Alcohol abuse is defined as 7 or more drinks per week for a woman or 14 or more drinks per week for a man.\n* History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.\n* Presence of recurring gastrointestinal symptoms (diarrhea, constipation, nausea, heartburn, etc.).\n* Presence of acute gastrointestinal symptoms within 7 days before the first dosing.\n* Use of medications for the timeframes and throughout the study (unless specified), with the exception of hormonal contraceptives and medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study intervention or participant safety (eg, topical drug products without significant systemic absorption).\n\n\\\u003CPatients only\\>\n\n* Current diagnosis of indeterminate colitis, inflammatory bowel disease-unclassified, Crohn's disease, infectious colitis, or ischaemic colitis.\n* Evidence of fulminant colitis or ASUC at Screening.\n* The patient meets the following criteria:\n\n  * Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy for UC\n  * Evidence of abdominal abscess or toxic megacolon during Screening\n  * Imminent need for surgery or with elective surgery scheduled to occur during the study\n* Positive Clostridium difficile toxin test during Screening. However, re-screening can be undertaken following successful treatment.\n* Complications or history of immunologic, autoimmune or chronic inflammatory disorders (eg, uveitis, rheumatoid arthritis, ankylosing spondylitis or spondyloarthritis, psoriasis) other than UC.\n* Any evidence of colonic dysplasia, adenomas or polyposis. Those that have been completely resected can be included.\n* Mentally or legally incapacitated.\n* A history of malignant neoplasm within the last 5 years, except for adequately treated non-metastatic basal or squamous cell cancers of the skin (within 1 year) or carcinoma in situ of the uterine cervix (within 3 years) that has been fully treated and shows no evidence of recurrence.\n* History of hypersensitivity or idiosyncratic reaction to the study interventions, excipients (including Lactose) or related compounds, or severe food allergies.\n* History or presence of alcoholism within 6 months before the first dosing. Alcohol abuse is defined as 7 or more drinks per week for a woman or 14 or more drinks per week for a man.\n* History of drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana) within 1 month or hard drugs (such as cocaine, phencyclidine \\[PCP\\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 3 months prior to screening.\n* Previously untreated UC.\n* Initiation or change in the dose of the following medicines; oral sulfasalazine, aminosalicylate, oral or rectal corticosteroid, ciclosporin, mercaptopurine, azathioprine, methotrexate, anti-TNF biologic, anti-integrin, anti-IL-12\u002F23, anti IL-23 biologics, JAK inhibitor, or S1P1 modulator.\n* Fecal microbiota transplantation within 4 weeks prior to baseline endoscopy.\n* Use of medications for the timeframes specified below and throughout the study (unless specified), with the exception of hormonal contraceptives and medications exempted by the investigator on a case-by-case basis because they are judged unlikely to affect the PK profile of the study intervention or participant safety (eg, topical drug products without significant systemic absorption):\n\n  * depot injection or implant within 3 months prior to dosing;\n  * live attenuated vaccines within 1 month prior to dosing;\n  * MAOIs within 30 days prior to dosing and until 14 days after the last drug administration;\n  * any drug known to induce or inhibit hepatic drug metabolism, including St. John's Wort, within 30 days prior to dosing;\n  * prescription medications within 14 days prior to dosing;\n  * any vaccine, including COVID-19 vaccine, within 14 days prior to dosing;\n  * OTC medications and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days or 5 half-lives (whichever is longer) prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily).\n* History or evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis diagnosed by a positive QFT-GIT. In case of an indeterminate, borderline, or invalid result, the QFT-GIT may be repeated once or a T-SPOT® TB test may be used to confirm the result. If the results are indeterminate\u002Fborderline at repeat testing, the participant should be excluded.\n\n\\\u003CHealthy Volunteers and Patients\\>\n\n* Use of any investigational drug within 30 days or 5 half-lives of that investigational drug (whichever is longer) before the first dosing.\n* Abnormal clinical laboratory test results (and confirmed by a single repeat measurement, if deemed necessary) at Screening or admission.\n* Positive result at Screening or admission for the urine or breath alcohol screen, or urine drug screen.\n* Clinically significant abnormal laboratory test results or positive serology test results at Screening for HIV-1 Ag with HIV-1 and HIV-2 Ab, HBsAg, HBcAb (even if the result for HBcAb is positive, the negative result for HBV DNA is acceptable for study participation), or HCVAb.\n* Increased CV proarrhythmic potential, confirmed with repeat per investigator discretion, at Screening or admission.\n* Clinically significant abnormalities in blood pressure, pulse rate, oral temperature and respiratory rate at Screening or admission. If positive, the test should be repeated 2 more times and the average of the 3 results should be used to determine the participant's eligibility.\n* Poor venous access as determined by the investigator at Screening.\n* The participant smoked (including use of tobacco and\u002For nicotine containing products including e-cigarettes, snuff, chewing tobacco, cigars, pipes, or nicotine-replacement products) within 3 months before Screening or has a positive urine cotinine at Screening or admission, and the inability to stop using nicotine-containing products, during confinement in the study site. A smoker will be defined as any participant who reports nicotine containing products use or has a urine cotinine greater than 100 ng\u002FmL.\n* Female participant who is positive for pregnancy test or lactating or planning to become pregnant during this study or within 3 months after the last study intervention administration.\n* Donation of blood ≥500 mL or significant blood loss within 56 days before the first dosing, or blood plasma or platelet donation within 14 days before the first dosing, or blood transfusion within 90 days before the first dosing.\n* Participant working at or having an immediate family member (spouse or children) who works at the study site or is a staff member of the sponsor and directly involved in this trial.\n* Engagement in strenuous exercise (eg, moving large bulky items, bodybuilding) within 14 days before the first dosing.\n* Presence of orthodontic braces or orthodontic retention wires, or any physical findings in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure.\n* Any participant who, in the opinion of the investigator, is not considered to be suitable and is unlikely to comply with the study protocol for any reason.",true,"55 Years",{"count":159,"type":23},90,[161],"PHASE1","A study to investigate the safety, tolerability, and pharmacokinetics (PK) of ONO-6414 orally in healthy adult participants and in patients with active ulcerative colitis (UC).",[29],[165,166,139],"ONO-6414-01","ONO-6414","2026-08-04",{"date":169,"type":36},"2026-08-06",{"date":171,"type":23},"2026-09-30",{"date":173,"type":23},"2028-01-31",{"name":175,"class":43},"Ono Pharmaceutical Co., Ltd.",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":183,"targetDuration":4,"studyType":24,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":70},"100650412","phase-2-a-study-to-evaluate-the-efficacy-safety-tolerability-and-pharmacokinetics-of-ptt-621-in-patients-with-moderately-to-severely-active-ulcerative-colitis-100650412","NCT07747155","A Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of PTT-621 in Patients With Moderately to Severely Active Ulcerative Colitis","A Phase IIa, Multicenter, Single-Arm Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Characteristics of PTT-621 in Patients With Moderately to Severely Active Ulcerative","Inclusion Criteria:\n\n* 1\\. Male or female participants aged 18-70 years inclusive at screening. 2. Diagnosed with ulcerative colitis (UC) at least 60 days prior to the first dose of IP.\n\n  3\\. Participants have active UC at screening, defined as a modified Mayo score of 5-9.\n\n  4\\. Endoscopic evidence of UC extending ≥15 cm from the anal verge during the screening period.\n\n  5\\. Participants have had inadequate\u002Floss of response or intolerance to at least one of the following: 5-aminosalicylic acid, glucocorticoids, immunosuppressants, biologics, and\u002For small-molecule targeted therapies.\n\n  6\\. Participants currently receiving the following UC therapies are eligible if they meet stability requirements: Oral glucocorticoids: with stable dosing for ≥2 weeks prior to screening endoscopy；Oral 5-ASA: Stable dose for at least 2 weeks prior to the endoscopic assessment during the screening period.\n\n  7\\. Female participants of childbearing potential must have a negative serum\u002Furine pregnancy test at screening.\n\n  8\\. Willing to use at least one highly effective contraceptive method during sexual intercourse throughout the study and until 1 month after the last dose of IP.\n\n  9\\. Willing to refrain from sperm\u002Fova donation throughout the study and until 1 month after the last dose of IP.\n\n  10\\. Able and willing to provide written informed consent and comply with all protocol-specified procedures and visit schedules.\n\nExclusion Criteria:\n\n* 1\\. A current diagnosis of Crohn's disease (CD), indeterminate colitis, infectious colitis, or any other colitis\u002Fenteritis that could interfere with efficacy evaluation； 2. Has UC complications (e.g., fulminant colitis, toxic megacolon, prior total or partial colectomy, or other conditions requiring surgery)； 3. Prior or current gastrointestinal dysplasia； 4. History of gastrointestinal malignancy, or any current evidence of gastrointestinal cancer.",{"count":184,"type":23},40,[26],"This Phase IIa, multicenter, single-arm trial evaluates the efficacy, safety, tolerability, and pharmacokinetics of PTT-621 tablets in adults (18-70 years) with moderate-to-severe active ulcerative colitis (UC) who have inadequate response\u002Fintolerance to standard therapies. Participants receive PTT-621 for 12 weeks. The primary endpoint is the proportion of participants achieving endoscopic improvement at Week 12. Secondary endpoints include safety, clinical remission, clinical response, symptom response, pharmacokinetics, and inflammatory biomarkers. The study is sponsored by Pyrotech Therapeutics, with ethical approval from Renji Hospital's IRB.",[29],[189,114],"Ulcerative Colitis",{"date":191,"type":36},"2026-08-07",{"date":193,"type":23},"2026-08",{"date":195,"type":23},"2028-06",{"name":197,"class":43},"Pyrotech Therapeutics, Inc.",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":205,"targetDuration":207,"studyType":208,"phases":4,"briefSummary":209,"conditions":210,"keywords":214,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100611202","zymfentra-infliximab-dyyb-real-world-cohort-study-100611202","NCT07237516","Zymfentra (Infliximab-dyyb) REal World Cohort STudy","ZEST","Inclusion Criteria:\n\n\\- 1. Adult patients, age 18 years or older, with Crohn's disease (CD), ulcerative colitis (UC) or Inflammatory Bowel Disease Unclassified (IBDU), who are either starting Zymfentra at week 10 (IFX-dyyb) in the setting of standard-of-care initiation with intravenous Infliximab (IFX) originator or IFX biosimilars induction therapy at weeks 0,2,6 or switching from intravenous IFX originator or IFX biosimilars during maintenance therapy to Zymfentra (IFX-dyyb) 2. Anticipation that the patient will be followed by the participating center for the next 12 months.\n\n3\\. Diagnosis of CD, UC or IBDU must be established based on standard clinical, radiographic, endoscopic, and histologic criteria as described below.\n\nThe following diagnostic criteria were developed by the NIDDK IBD Genetics Consortium and are provided as guidelines to complete documentation on individuals with CD, UC or IBDU:\n\nA) Symptoms including one or more: diarrhea, rectal bleeding, abdominal pain, fever, complicated perianal disease, extraintestinal manifestations, weight loss or failure to thrive.\n\nAND B) Symptoms on two or more occasions separated by at least 8 weeks or ongoing symptoms of at least 6 weeks duration. When there has been a single episode of colitis (in some instances less than 6 weeks duration) resulting in colectomy and resolution of disease symptoms, pathology on the colectomy specimen should be consistent with idiopathic IBD and microbiology studies should be negative.\n\nAND\n\nC) One or more of the following providing objective evidence of inflammation:\n\nEndoscopic: Mucosal edema, erythema, loss of normal submucosal vasculature, friability, ulceration, stricture formation, pseudopolyps, mucosal edema, erythema. Where there are only minor changes (mucosal edema, erythema, loss of normal submucosal vasculature, friability) mucosal biopsies should have been done to confirm the presence of IBD.\n\nRadiologic: Mucosal thickening and\u002For nodularity, ulceration, stricture, pseudopolyps, fistula formation, pseudosacculation. Minor changes alone (mucosal thickening and\u002For nodularity) should not be sufficient to make a diagnosis of IBD.\n\nHistologic: Mucosal erosion or ulceration, architectural changes of crypts, Paneth cell metaplasia (in colon), transmural inflammatory infiltrate\\*, fibrosis of muscularis propria\\*, noncaseating granuloma\\*.\n\n\\* CD\n\nIndividuals with IBD should be classified into one of three categories, based on most recent diagnosis:\n\nCrohn's disease (CD):\n\n1. Evidence of small intestinal inflammation with endoscopically, radiologically or histologically demonstrated ulcerations, fistulation, mucosal fissuring, nodularity or cobblestoning, stricture formation or histologically demonstrated transmural inflammation with or without granuloma formation.\n2. Isolated esophageal, gastric or duodenal inflammation with the finding of noncaseating granuloma.\n3. Colonic inflammation which is patchy (normal segments separating areas of inflammation, as described above) or associated with one or more of the following features: complete rectal sparing, multiple (\\>10) aphthoid ulcers, deep ulceration (into the muscularis propria), transmural inflammation, extensive fibrosis and wall thickening, fistulation, non-caseating granuloma. (N.B. See note below regarding patchiness of endoscopically observed inflammation in patients with partially treated ulcerative colitis.)\n4. The presence of complex suppurative perianal disease (i.e. more than a superficial fistula or uncomplicated superficial abscess).\n5. If there are fewer than 10 aphthoid ulcers in the cecum (and the rest of the colon appears normal) in a patient with small bowel disease then this should be called small bowel disease only. Similarly, if the colon is normal except for the presence of a fistula extending from inflamed small bowel, the patient should be said to have small bowel disease alone. If the cecum is involved with ulcers larger than aphthoid ulcers or ulcers that are deep or if the involvement has resulted in deformity of the cecum this would be considered to be colonic involvement.\n\nUlcerative Colitis (UC)\n\n1\\) Superficial inflammation and\u002For ulceration (involving only the mucosa and submucosa) of the colon which is continuous from the rectum extending proximally without skip lesions or complete rectal sparing (N.B. Relative rectal sparing is allowed for patients receiving topical rectal therapy; patchiness of endoscopic inflammation may be observed in patients with partially treated ulcerative colitis).\n\n2\\) In patients with proctitis or left-sided ulcerative colitis there may be an area of inflammation in the cecum, usually surrounding the appendiceal orifice.\n\n3\\) No inflammation of the small intestine (\"backwash ileitis\" is allowed - non-stricturing superficial inflammation of the terminal ileal mucosa associated with severe pancolitis which resolves following medical or surgical treatment of the colitis).\n\n4\\) No features of Crohn's disease listed above.\n\nInflammatory Bowel Disease Unclassified (IBDU):\n\n1. Confirmed IBD by A, B and C above.\n2. Physician unable to classify individual into either CD or UC based on above criteria and\u002For patient has features of both CD and UC with none of the feature's diagnostic of one or the other.\n\nExclusion Criteria:\n\n* 1\\.\n\nPatients will be excluded if they meet any of the following criteria:\n\n1. Inability to provide informed consent.\n2. Non-English speaking\n3. Patients presenting for a one-time consultation.",{"count":206,"type":23},200,"12 Months","OBSERVATIONAL","The goal of this observational study is to learn about how effective Zymfentra (IFX=dyyb) is when treating patients with Crohn's disease (CD) and ulcerative colitis (UC) Does Zymfentra lead to a reduction in symptoms at intervals throughout one year? Participants being prescribed Zymfentra (IFX-dyyb as part of their regular medical care for CD or UC will answer online survey questions about their bowel habits for 1 year.",[29,211,212,213],"Crohn's Disease (CD)","Indeterminate Colitis","Inflammatory Bowel Disease (IBD)",[215,203],"Zymfentra",{"date":217,"type":36},"2026-08-05",{"date":219,"type":36},"2025-11-20",{"date":221,"type":23},"2028-11-03",{"name":223,"class":99},"University of North Carolina, Chapel Hill",11,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":232,"targetDuration":4,"studyType":24,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":70},"100650309","phase-1-alpha-0261-tablets-for-moderate-to-severe-ulcerative-colitis-100650309","NCT07744646","Alpha-0261 Tablets for Moderate-to-Severe Ulcerative Colitis","An Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Alpha-0261 Tablets in Patients With Moderate to Severe Active Ulcerative Colitis (UC)","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), male or female.\n* Diagnosed with ulcerative colitis at least 3 months prior to screening; this diagnosis must be confirmed by endoscopy or histology.\n* Patients must have moderate-to-severe active ulcerative colitis, as defined by an mMS score of 4 to 9 (blood in stool subscore ≥ 1, frequency of bowel ovements subscore ≥ 1, and colonoscopy subscore ≥ 2 \\[as confirmed by the study site's image reviewer\\]; the sum of these three subscores must be at least 4).\n* The investigator determines that the participant has had an inadequate response to or is intolerant of at least one conventional therapy aminosalicylates, corticosteroids, or immunosuppressants) or a biologic agent (anti-TNF-α, anti-α4β7 integrin, or anti-IL-12\u002F23 antibodies, etc.).\n* Voluntarily sign the informed consent form and be willing to comply with the study procedures and complete the trial in accordance with the protocol.\n\nExclusion Criteria:\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 history of or is anticipated to require surgical intervention for ulcerative colitis during the study, including but not limited to ostomy, ileal pouch-anal anastomosis, and intestinal resection.\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\n* Has had major surgery within 4 weeks before Screening or has a major surgery (ie, surgical procedure requiring general anesthesia) planned during the study\n* Has received protocol-specified prohibited medications",{"count":233,"type":23},10,[161],"The purpose of this protocol is to evaluate the safety and efficacy of Alpha-0261 in participants with moderately to severely active ulcerative colitis. The primary hypothesis is that Alpha-0261 is safe, and the secondary hypothesis is that Alpha-0261 is effective, as assessed by the proportion of participants achieving clinical remission per the complete modified Mayo score at Week 10.",[29],"2026-07-30",{"date":167,"type":36},{"date":240,"type":23},"2026-08-03",{"date":242,"type":23},"2027-03-20",{"name":244,"class":99},"The First Affiliated Hospital of Anhui Medical University",{"id":246,"slug":247,"hasResults":12,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":253,"targetDuration":207,"studyType":208,"phases":4,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":4},"100649914","the-fecal-immunoassay-occult-blood-test-combined-with-calprotectin-sequential-linkage-imaging-endoscopy-screening-strategy-for-monitoring-tumor-changes-associated-with-long-duration-ulcerative-colitis-100649914","NCT07742410","The Fecal Immunoassay Occult Blood Test Combined With Calprotectin Sequential Linkage Imaging Endoscopy Screening Strategy for Monitoring Tumor Changes Associated With Long-duration Ulcerative Colitis","Diagnostic Performance of Fecal Immunochemical Test Combined With Fecal Calprotectin Sequential Linked Color Imaging Endoscopy for Surveillance of Colitis-Associated Neoplasia in Long-standing Ulcerative Colitis: A Multicenter, Prospective Cohort Study","DETECT-UCAN","Inclusion Criteria:\n\n* Age 18-75 years, any gender.\n* Definite diagnosis of ulcerative colitis by clinical, endoscopic, and pathological criteria.\n* Meeting at least one of the following high-risk criteria (with first onset of mucopurulent bloody stool as the starting time): E1\u002FE2 disease duration \\>10 years; E3 disease duration \\>8 years; with primary sclerosing cholangitis (PSC); first-degree family history of colorectal cancer; history of colorectal neoplasia resected.\n* Discontinued any form of glucocorticoids for at least 4 weeks prior to enrollment.\n* In clinical remission at enrollment (stool frequency score \\\u003C3, rectal bleeding score = 0).\n* Able to understand the study, voluntarily participate, and sign written informed consent.\n\nExclusion Criteria:\n\n* Presence of other gastrointestinal diseases or tumors.\n* Severe comorbidities (e.g., cardiopulmonary insufficiency, hepatic or renal failure) that may affect study results or preclude tolerance of endoscopy.\n* Currently taking antiplatelet or anticoagulant medications (aspirin, warfarin, rivaroxaban, etc.).\n* Pregnant or breastfeeding women.\n* History of total or subtotal colectomy.",{"count":254,"type":23},250,"Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with an increased risk of colorectal cancer, known as UC-associated neoplasia (UCAN). Current guidelines recommend regular colonoscopy surveillance for long-standing UC patients, but this strategy faces challenges including poor adherence and low neoplasia detection rates. This study aims to evaluate the diagnostic performance of a non-invasive pre-screening strategy combining fecal immunochemical test (FIT) and fecal calprotectin (FC), followed by linked color imaging (LCI) colonoscopy, for detecting UCAN in patients with long-standing UC.\n\nThis is a multicenter, prospective, diagnostic cohort study. Eligible patients with long-standing UC (disease duration \\>8 years for extensive colitis or \\>10 years for left-sided colitis, or with PSC) will undergo FIT and FC testing, followed by LCI colonoscopy within 4 weeks regardless of stool test results. The primary outcome is the diagnostic performance (sensitivity, specificity, PPV, NPV) of combined FIT+FC testing for UCAN, using LCI colonoscopy with histopathology as the reference standard. A total of 250 participants will be enrolled from 6 centers in China. Secondary outcomes include UCAN detection rate, feasibility indicators, patient adherence and acceptability, optimal cut-off values for FIT and FC, and 12-month miss rate.",[29],"2026-07-29",{"date":240,"type":36},{"date":260,"type":23},"2026-07-23",{"date":262,"type":23},"2029-12-31",{"name":264,"class":99},"Qilu Hospital of Shandong University",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":24,"phases":276,"briefSummary":277,"conditions":278,"keywords":279,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100645623","phase-4-efficacy-of-upadacitinib-re-induction-therapy-in-patients-with-ulcerative-colitis-who-lost-response-to-30-mg-maintenance-dose-100645623","NCT07700446","Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose","A Single Arm, Multicenter Open-Label Interventional to Evaluate the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose","ReCOUP","Inclusion Criteria:\n\n1. Subjects must voluntarily sign and date an informed consent, approved by an IEC\u002FIRB, prior to the initiation of any screening or study-specific procedures.\n2. Individuals at least 18 years old and less than 65 years.\n3. Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug:\n\n   * Serum alanine transaminase (ALT) \\\u003C 2 × ULN;\n   * Serum aspartate aminotransferase (AST) \\\u003C 2 x ULN;\n   * Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula \\> 0 mL\u002Fmin\u002F1.73 m2;\n   * Total white blood cell (WBC) count \\> 2,500\u002FμL;\n   * Absolute neutrophil count (ANC) \\> 1,500\u002FμL;\n   * Platelet count \\> 100,000\u002FμL;\n   * Absolute lymphocyte count \\> 850\u002FμL;\n   * Hemoglobin \\> 10 g\u002FdL.\n4. Are willing and able to comply with procedures required in this protocol.\n5. Subjects must not be incarcerated and must be freely willing and able to provide informed consent. Examples of subjects unable to freely provide informed consent may include some adults under legal protection measures (e.g., under guardianship\u002Fcuratorship) or unable to express their consent and select adults under psychiatric care. Investigator's discretion should be applied.\n6. Diagnosis of moderate to severe active ulcerative colitis with a documented initial response to upadacitinib treatment (defined as adapted Mayo score of 5-9) and subsequent documented loss of response to upadacitinib 30 mg QD dose. This should be within 8 weeks of screening. This will allow for short term non-UC related flares to self-resolve, while at the same time allowing for adequate time interval between appointments.\n7. Subject has documented diagnosis of moderate to severe active UC with a modified Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 at the time of screening.\n8. Pregnancy testing in females of childbearing potential\u002Findividuals of childbearing potential; Contraception Recommendations of this protocol :\n\n   Females of childbearing potential\u002FIndividuals of childbearing potential must have a negative serum pregnancy test at the Screening Visit.\n9. Female subjects of childbearing potential must practice at least 1 protocol-specified method of birth control, from Study Day 1 through at least 30 days after the last dose of study drug. Female subjects of nonchildbearing potential do not need to use birth control.\n\nExclusion Criteria:\n\n1. Subject with current diagnosis of Crohn's Disease or diagnosis of indeterminate colitis.\n2. Current diagnosis of fulminant colitis and\u002For toxic megacolon.\n3. History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.\n4. Conditions that could interfere with drug absorption including but not limited to short bowel syndrome.\n5. History of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or is planning bowel surgery.\n6. Subject has active TB or latent TB.\n7. Subject who received fecal microbial transplantation within 30 days prior to Baseline.\n8. Subject with new or chronic systemic use of known strong cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers while on UPA therapy should be evaluated by caring physician as to possibility of this medication being responsible for the loss of response to UPA. Herbal therapies and other traditional medicines are defined as any herbal formulation that is intended to treat or prevent health problems and may include supplements based on herbs which the subject is taking.\n9. Subject currently receiving total parenteral nutrition (TPN) or plan to receive TPN at any time during study treatment.\n10. Subject with positive C. difficile toxin stool assay during screening.\n11. Infection(s) requiring treatment with intravenous anti-infectives within 30 days prior to the Baseline visit or oral\u002Fintramuscular anti-infectives within 14 days prior to the baseline visit.\n12. Chronic recurring infection and\u002For active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study\n13. Subject has current or past history of recurrent or disseminated (even a single episode) herpes zoster\n14. Subject has current or past history of disseminated (even a single episode) herpes simplex\n15. Prior or current gastrointestinal (GI) dysplasia, other than completely removed dysplastic lesion in any biopsy performed during or before the screening endoscopy.\n16. History of any malignancy, except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.\n17. History of gastrointestinal (GI) perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk of GI perforation per investigator's judgment.\n18. History of an allergic reaction or significant sensitivity to constituents of upadacitinib (and its excipients)\n19. Subject who previously received stem cell transplantation\n20. Subject has been a previous recipient of an organ transplant which requires continued immunosuppression.\n21. History of cerebrovascular accident, myocardial infarction, coronary stenting, or aortocoronary bypass stenting or retinal vein occlusion; however, if the investigator determines there are no suitable treatment alternatives available for a subject who has experienced one of these events more than 6 months prior to the Baseline visit, the investigator must document a favorable benefit-risk assessment to justify the subject's inclusion in the study.\n\n    In patients with known VTE risk factors other than cardiovascular or alignancy risk factors, participation in this clinical trial is considered the most suitable treatment option among treatment alternatives and the risks and benefits have been discussed with the subject.\n22. A serious AE or AE that is identified or a possible risk of UPA during prior treatment with upadacitinib that is deemed to have a causal relationship with upadacitinib by Investigator\n23. Subjects who have been treated with any investigational drug of chemical or biologic nature within 30 days or five half-lives (whichever is longer) prior to the first dose of study treatment or who are currently enrolled in another interventional clinical study.\n24. Received treatment with rectal aminosalicylates or corticosteroids, other enemas\u002Fsuppositories (other than required for endoscopy), within 7 days prior to the Screening endoscopy and during the remainder of the Screening Period.\n25. Received cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 30 days prior to Baseline.\n26. Subjects who received azathioprine or 6-mercaptopurine within 10 days of Baseline.\n27. Subjects who received intravenous corticosteroids within 14 days prior to screening or during the screening period.\n28. Subjects who require corticosteroids to remain in the study\n29. Subject who received non-steroidal anti-inflammatory drugs (NSAIDs) (except topicalNSAIDs and the useof low dose aspirin for cardiovascular \\[CV\\] protection) within 7 days prior to baseline","64 Years",{"count":275,"type":23},100,[56],"ReCOUP is a multicenter clinical study designed to evaluate the efficacy of upadacitinib (Rinvoq®) in patients with ulcerative colitis whose disease has become active again despite maintenance treatment with upadacitinib 30 mg.\n\nThis study involves adult patients aged 18 to 64 years with active ulcerative colitis, who are being treated with upadacitinib and are not participating in another interventional clinical trial.\n\nParticipation in this study will depend on the patients' response to treatment during the 52-week maintenance period.\n\nSeveral follow-up visits will be scheduled throughout the study according to a timetable defined by the protocol, and additional visits may be arranged if necessary depending on patients' health status.",[29],[139,280,281],"upadacitinib","re-induction",{"date":283,"type":36},"2026-07-31",{"date":285,"type":23},"2026-11-15",{"date":287,"type":23},"2030-04",{"name":289,"class":99},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":312},"100626931","real-world-effectiveness-and-safety-of-upadacitinib-plus-vedolizumab-vs-upadacitinib-monotherapy-during-induction-in-moderate-to-severe-ulcerative-colitis-100626931","NCT07442045","Real-World Effectiveness and Safety of Upadacitinib Plus Vedolizumab vs Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis","Real-World Comparative Effectiveness and Safety of Upadacitinib Plus Vedolizumab Versus Upadacitinib Monotherapy During Induction in Moderate-to-Severe Ulcerative Colitis: A Multicenter Retrospective Cohort Study","Inclusion Criteria:\n\n1. Age 18 years or older at the index date.\n2. Established diagnosis of ulcerative colitis for at least 3 months, supported by compatible clinical, endoscopic, and histologic findings.\n3. Moderately to severely active ulcerative colitis at baseline, defined as a modified Mayo score of 4 to 9 and a Mayo endoscopic subscore of at least 2.\n4. Initiation of upadacitinib induction therapy during the predefined study period.\n5. For the combination-therapy group, initiation of vedolizumab concomitantly with upadacitinib at the index date.\n\nExclusion Criteria:\n\n1. Crohn's disease, inflammatory bowel disease unclassified, indeterminate colitis, or another form of non-ulcerative-colitis colitis.\n2. Previous colectomy or colectomy planned at the index date.\n3. Previous exposure to upadacitinib or vedolizumab.\n4. Initiation of another biologic or small-molecule advanced therapy during the 8-week induction period, except for vedolizumab in the combination-therapy group.",{"count":133,"type":23},"This multicenter retrospective comparative cohort study evaluated the real-world effectiveness and safety of upadacitinib plus vedolizumab compared with upadacitinib monotherapy during 8-week induction in adults with moderate-to-severe ulcerative colitis.\n\nConsecutive eligible patients who initiated upadacitinib induction therapy, either as monotherapy or with concomitant vedolizumab, between January 2023 and September 2025 at six tertiary inflammatory bowel disease referral centers in China were included.\n\nThe primary outcome was modified Mayo clinical remission at week 8. Secondary outcomes were modified Mayo clinical response, C-reactive protein normalization among patients with an elevated baseline C-reactive protein concentration, and endoscopic remission. Safety outcomes were assessed from the index date through the week-8 assessment.",[29],[189,301,302,303,304],"Upadacitinib","Vedolizumab","Combination Therapy","Real-World Study",{"date":283,"type":36},{"date":307,"type":36},"2023-01-01",{"date":309,"type":23},"2026-09-01",{"name":311,"class":99},"Sixth Affiliated Hospital, Sun Yat-sen University",6,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":321,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":70},"100601521","fecal-biomarker-response-evaluation-for-super-early-efficacy-in-ulcerative-colitis-100601521","NCT07111572","Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis","Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study","FORESEE-UC","Inclusion Criteria:\\*\\*\n\n* Age 18-75 years, UC diagnosis with endoscopic Mayo score (MES) ≥2\n* Moderate-to-severe activity (Full Mayo Score ≥6)\n* Initiating vedolizumab or infliximab within 7 days after baseline\n* Biologic-naïve or prior exposure to only one TNF-α inhibitor\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Pregnancy\u002Flactation\n* Contraindications to biologics (e.g., active TB, severe infection)\n* Experimental drug use within 4 weeks prior to baseline",{"count":275,"type":23},"This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at \\*\\*Week 2 and Week 4\\*\\* after initiating biologic therapy (vedolizumab or infliximab) can predict clinical response at \\*\\*Week 14\\*\\* and mucosal healing at \\*\\*Week 52\\*\\* in moderate-to-severe ulcerative colitis (UC) patients. Primary outcome: clinical remission rate at Week 14.",[29,324,325],"Fecal Calprotetin","FIT",[327,328,325],"UC","fecal calprotectin","2026-07-27",{"date":331,"type":36},"2026-07-28",{"date":333,"type":36},"2025-08-01",{"date":335,"type":23},"2026-12-01",{"name":264,"class":99},{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":343,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":345,"targetDuration":346,"studyType":208,"phases":4,"briefSummary":347,"conditions":348,"keywords":350,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":354,"leadSponsor":356,"locationsCount":70},"100601498","dynamic-uc-early-qfit-and-calprotectin-change-predicting-relapse-in-biologic-naive-ulcerative-colitis-100601498","NCT07111273","DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis","Diagnostic Value of Quantitative Fecal Immunochemical Test (qFIT) and Calprotectin (FC) Dynamic Changes at 2 Weeks for Predicting 52-Week Relapse or Treatment Escalation in Biologic-Naive Ulcerative Colitis: A Multicenter, Prospective Cohort Study (DYNAMIC-UC)","DYNAMIC-UC","Inclusion Criteria:\n\n* Age 18-75 years.\n* Established diagnosis of Ulcerative Colitis (UC) confirmed by clinical, endoscopic, and histopathological criteria.\n* Endoscopic disease activity (Mayo Endoscopic Subscore ≥ 2) confirmed by colonoscopy during screening.\n* Biologic-naive (no prior exposure to any biologic agent \\[e.g., infliximab, adalimumab, vedolizumab, ustekinumab\\] or JAK inhibitor).\n* No use of systemic corticosteroids (oral or intravenous) within 4 weeks prior to Baseline (Week 0) visit.\n* If using oral or rectal mesalazine\u002F5-ASA preparations, dose must have been stable for ≥2 weeks prior to Baseline (Week 0).\n\nWilling and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis or high suspicion of Crohn's disease, ischemic colitis, infectious colitis, radiation colitis, intestinal tuberculosis, or other types of colitis.\n\nPresence of other conditions clearly causing intestinal bleeding (e.g., acute hemorrhoidal bleeding, colorectal cancer, large colorectal polyps \\>1cm, intestinal vascular malformations).\n\n* Untreated systemic conditions that may cause intestinal bleeding (e.g., thrombocytopenia \\[PLT \\\u003C50 x 10\\^9\u002FL\\], severe coagulopathy).\n* Regular use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban).\n* Pregnancy or lactation.\n* Any other condition deemed by the investigator to make the patient unsuitable for study participation.",{"count":275,"type":23},"14 Weeks","This multicenter prospective cohort study aims to evaluate whether a \\>50% decrease or normalization of both quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC) levels at 2 weeks after starting conventional therapy (mesalazine or corticosteroids) can predict clinical relapse or need for biologic\u002FJAK inhibitor therapy escalation by 52 weeks in biologic-naive patients with active ulcerative colitis (UC). Secondary objectives include assessing predictive value at 4 weeks, building dynamic prediction models, conducting health economic evaluation (Number Needed to Test, NNT), and exploring baseline predictors of early biomarker response. Patients will be observed during standard care with stool samples collected at Weeks 0, 2, and 4. Biomarker results will be blinded to clinicians\u002Fpatients until study completion.",[29,324,325,349],"Biomarker",[139,328,325,351],"biologic-naive",{"date":331,"type":36},{"date":333,"type":36},{"date":355,"type":23},"2026-12-30",{"name":264,"class":99},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":364,"targetDuration":4,"studyType":24,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":70},"100631963","phase-2-the-purpose-of-this-study-is-to-evaluate-the-efficacy-and-safety-of-627-in-the-treatment-of-uc-100631963","NCT07507513","The Purpose of This Study is to Evaluate the Efficacy and Safety of 627 in the Treatment of UC","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of SSGJ-627 in Subjects With Moderate to Severe Active Ulcerative Colitis (UC)","Inclusion Criteria:\n\n1. Able to understand and comply with the requirements of the study protocol, and sign the written informed consent form (ICF).\n2. Male or female subjects aged 18-75 years old when signing the ICF.\n3. Subjects must have been diagnosed with UC for at least 3 months prior to randomization.\n4. Moderate to Severe Active Ulcerative Colitis (UC).\n5. Inadequate or lost response, intolerance to one or more therapies, or corticosteroid dependence.\n6. Female subjects of childbearing potential and male subjects (and their female partners) must use highly effective contraception from the screening period through at least 6 months after the last dose. The subjects must have no plans for pregnancy, sperm donation, or oocyte donation during the same period (from screening through at least 6 months post-last dose).\n\nExclusion Criteria:\n\n1. History of severe opportunistic infection within 2 months prior to screening or randomization that remains not adequately controlled.\n2. Receiving protocol-prohibited treatments prior to screening or randomization.\n3. Presence of any laboratory test abnormalities during screening and\u002For determination by the investigator that enrollment in the study may pose uncontrollable safety risks to the subject.\n4. Positive hepatitis B test result, positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus antibody (HIV Ab), or positive serum Treponema pallidum antibody (TP Ab) during screening, as specified in the protocol.\n5. History of clinically significant cardiovascular and cerebrovascular diseases within 6 months prior to screening.\n6. History of any malignancy within 5 years prior to screening or currently active malignancy.\n7. Allergy to the investigational medicinal product, any of its components, or excipients.\n8. History of alcohol or substance abuse within 6 months prior to screening.\n9. Undergone major surgery within 6 months prior to screening or planned major surgery during the study period.\n10. Blood donation or significant blood loss within 4 weeks prior to screening.\n11. Participation in any drug clinical trial within 3 months prior to screening or within 5 half-lives of the investigational drug (whichever is longer).\n12. Vaccination with live\u002Fattenuated live vaccines within 4 weeks prior to screening or planned vaccination during the study period.\n13. Pregnant or lactating female subjects.\n14. Other conditions deemed unsuitable for trial participation by the investigator.",{"count":365,"type":23},288,[26],"This study will evaluate the efficacy and safety of 627 in patients with UC.",[29],"2026-07-26",{"date":331,"type":36},{"date":372,"type":36},"2026-03-28",{"date":374,"type":23},"2029-12-30",{"name":376,"class":43},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.",{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":156,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":384,"targetDuration":4,"studyType":24,"phases":386,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":159},"100563732","phase-1-study-of-xmab942-in-healthy-participants-and-participants-with-ulcerative-colitis-100563732","NCT06619990","Study of XmAb942 in Healthy Participants and Participants With Ulcerative Colitis","A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy Participants Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study in Participants With Moderate-To-Severe Active Ulcerative Colitis.","Inclusion Criteria:\n\nParts A and B\n\n* Age 18-55\n* Must be in good health with no significant medical history\n* Clinical laboratory values within normal range\n* BMI 18-35 (inclusive)\n* Contraceptive use by men or women consistent with local regulations\n* Able and willing to provide written informed consent\n\nPart C\n\n* Age 18-75\n* Must be in good health with no significant medical history\n* UC diagnosis ≥ 3 months prior to screening\n* Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1\n* Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy\n* Must have inadequate response to, loss of response to, or intolerance to at least 1 of the conventional or advanced therapies of UC\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\nParts A and B\n\n* Any physical or psychological condition that prohibits study completion\n* History of suicidal behavior or suicidal ideation\n* Heavy use of nicotine containing products\n* HIV, hepatitis B and hepatitis C positive\n* Cardiac arrhythmia, or clinically significant abnormal ECG\n* Active use of prescription medications within 14 days of Day -1\n* Active use of over-the-counter, or herbal medication within 7 days of Screening\n* Other investigational products within 30 days\n* Blood or plasma donation within 60 days\n* Pregnant or breastfeeding\n\nPart C\n\n* Any physical or psychological condition that prohibits study participation\n* Diagnosis of Crohn disease, indeterminate colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis.\n* Positive screen for Clostridium difficile (C. Difficile) toxins\n* HIV, hepatitis B and hepatitis C positive\n* Cardiac arrhythmia, or clinically significant abnormal ECG\n* Pregnant or breastfeeding\n\nOther protocol defined inclusion\u002Fexclusion criteria apply.",{"count":385,"type":23},270,[161,26],"The Phase 1 study described herein will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).",[29],[189,390,391],"Inflammatory Bowel Disease","Healthy Volunteers","2026-07-22",{"date":394,"type":36},"2026-07-24",{"date":396,"type":36},"2024-10-10",{"date":398,"type":23},"2029-01",{"name":400,"class":43},"Xencor, Inc.",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":156,"sex":18,"minAge":407,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":411,"conditions":412,"keywords":417,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":426,"locationsCount":70},"100610171","assessment-and-educational-intervention-to-reduce-ultra-processed-food-consumption-in-pediatric-patients-with-ibd-100610171","NCT07224113","Assessment and Educational Intervention to Reduce Ultra-processed Food Consumption in Pediatric Patients With IBD","Inclusion Criteria:\n\n* Diagnosis of IBD (Crohn's disease, Ulcerative Colitis, IBD-U) for at least 3 months\n* Age 10 through \\\u003C 22 years at the time of enrollment (i.e., up to the day before the 22nd birthday)\n* Followed by a gastroenterologist at Connecticut Children's\n* IBD in clinical remission based on calculated PUCAI score \\\u003C10 or PCDAI score of \\\u003C10\n* Receiving medical infusions at CCMC Infusion Center as part of IBD treatment\n* Participants must be on full oral intake and not have major dietary restrictions or require oral nutrition supplements\n\nExclusion Criteria:\n\n* Following a medically prescribed or restrictive diet such as Crohn's Disease Exclusion Diet (CDED), ketogenic diet, Specific Carbohydrate Diet (SCD), low FODMAP diet, gluten-free diet, paleo, or Whole30.\n* Receiving any nutrition through feeding tubes (including nasogastric \\[NG\\], nasojejunal \\[NJ\\], gastrostomy \\[G\\], or gastrojejunostomy \\[GJ\\] tubes)\n* History of bowel surgery within 3 months of study start affecting ability to sustain normal enteral intake\n* Non-English-speaking participants (as translation and short-form consent processes will not be used for this study)","10 Years","21 Years",{"count":410,"type":23},120,"This study explores whether simple nutrition education can help children and teens with inflammatory bowel disease (IBD) eat fewer ultra-processed foods (UPFs). UPFs include packaged snacks, sugary drinks, and fast food-items that are high in added sugars, fats, and artificial ingredients. Participants will complete online food recalls to measure what they eat and will then receive either nutrition handouts alone or handouts plus a short educational video about UPFs. Researchers will compare changes in UPF intake between the two groups after several weeks and ask families how useful and acceptable they found the materials. The goal is to identify an effective, practical way to support healthier eating habits and long-term gut health in pediatric IBD.",[114,413,29,213,414,415,416],"Crohn Disease (CD)","Ultra Processed Food","Nutrition Assessment","DGBI",[114,390,418,189,419],"Crohn Disease","Ultra processed food","2026-07-15",{"date":422,"type":36},"2026-07-16",{"date":424,"type":36},"2025-11-10",{"date":355,"type":23},{"name":427,"class":99},"Connecticut Children's Medical Center",{"id":429,"slug":430,"hasResults":12,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":70},"100647640","evaluation-of-the-accuracy-of-immunostaining-of-claudin-2-to-detect-active-or-inactive-inflammation-in-endoscopic-biopsies-of-ibd-100647640","NCT07710287","Evaluation of the Accuracy of Immunostaining of Claudin 2 to Detect Active or Inactive Inflammation in Endoscopic Biopsies of IBD","Histologic Healing in IBD: Comparison of \"Standard\" Scores With Expression of Claudin 2 and Impact on Outcomes","LOGIC-2","Inclusion Criteria:\n\nConfirmed diagnosis of IBD\n\nExclusion Criteria:\n\nUnconfirmed diagnosis of IBD",{"count":275,"type":23},"In view of the increasing evidence of the importance of mucosal healing as a combination of endoscopic and histologic healing, and the complexity and lack of complete agreement of the evaluation of histologic healing in IBD, the aim of this study will be to evaluate the accuracy of a new methodology, the immunostaining for Claudine 2 as compared to others standard well-accepted scoring for histologic activity in IBD. The aim is compare the accuracy of this methodology and in addition the correlation with outcomes (i.e. relapse, hospitalization, surgery).",[29,418],[440,441,442,443,444],"Ulcerative colitis","Crohn's disease","Histology","Mucosa healing","Claudin","2026-07-13",{"date":447,"type":36},"2026-07-17",{"date":449,"type":36},"2025-02-14",{"date":451,"type":23},"2027-09",{"name":453,"class":99},"IRCCS Policlinico S. Donato",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":52,"enrollmentInfo":461,"targetDuration":4,"studyType":24,"phases":463,"briefSummary":465,"conditions":466,"keywords":467,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":70},"100641649","palmitoylethanolamide-in-ulcerative-colitis-100641649","NCT07609810","Palmitoylethanolamide in Ulcerative Colitis","The Effect of Palmitoylethanolamide on the Clinical Outcomes in Ulcerative Colitis Patients","Inclusion Criteria:\n\n* Confirmed diagnosis of ulcerative colitis (UC) by established clinical and endoscopic criteria.\n* Active mild-to-moderate UC patients defined by a SCCAI score ≥ 5 and \\\u003C 12 at screening, not responding to 5-aminosalicylates (5-ASA) defined as persistent rectal bleeding beyond 2 weeks or failure to achieve sustained symptom relief after 40 days of appropriate 5-ASA therapy, steroid-dependent defined as unable to reduce steroids below the equivalent of prednisolone 10 mg\u002Fday or budesonide below 3 mg\u002Fday within 3 months of starting steroids, without recurrent active disease or who have a relapse within 3 months of stopping steroids and they currently take azathioprine.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Alcohol or drug abuse.\n* Allergy or known hypersensitivity to palmitoylethanolamide.\n* Active infection (enteric or systemic).\n* Uncontrolled metabolic\u002F neurologic conditions: uncontrolled hypertension, uncontrolled diabetes, migraine disorders or other uncontrolled neurologic disease.\n* Other autoimmune diseases.\n* Severe or acute severe colitis requiring hospitalization.\n* UC patients requiring colectomy.\n* Crohn disease (CD), chronic pancreatitis, cholecystitis or other inflammatory conditions involving the gastrointestinal tract (GIT).\n* Patients with renal or liver disease.\n* Patients who have never been treated for UC.\n* Any patients on biologics.\n* Patients using NSAIDs or aspirin (due to interference with fecal calprotectin results).",{"count":462,"type":23},60,[464],"NA","Evaluate the effects of PEA supplementation on disease activity, health-related quality of life (HRQoL) and inflammatory biomarkers in patients with active mild-to-moderate UC.",[29],[468],"palmitoylethanolamide - endocannabinoid - disease activity",{"date":470,"type":36},"2026-07-14",{"date":472,"type":23},"2026-08-15",{"date":474,"type":23},"2029-02-15",{"name":476,"class":99},"Ain Shams University",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":496,"locationsCount":70},"100647175","a-national-multicenter-study-of-etrasimod-for-the-treatment-of-patients-with-active-uc-100647175","NCT07705126","A National Multicenter Study of Etrasimod for the Treatment of Patients With Active UC","Etrasimod for the Treatment of Active UC in Chinese Adults: A National Multicenter Prospective Registry Study (E-HEAL CHINA)","E-Heal China","Inclusion Criteria:\n\n1. Age ≥ 18 years at baseline, of any sex.\n2. Have a documented diagnosis of active ulcerative colitis (UC) and be judged by the treating physician as likely to benefit from etrasimod therapy. Active UC is defined as an endoscopic subscore ≥ 2, OR a stool frequency subscore (SFS) ≥ 1, OR a rectal bleeding subscore (RBS) ≥ 1. Any disease extent (Montreal classification E1, E2, or E3) is eligible. Participants must provide an endoscopy (including sigmoidoscopy) report obtained within 12 months prior to enrollment.\n3. Have been receiving etrasimod for no more than 6 months at the time of enrollment.\n4. Voluntarily sign a written informed consent form and have the ability to understand and complete study-related questionnaires and visit procedures.\n\nExclusion Criteria:\n\n1. Have any contraindication to etrasimod use as per the approved prescribing information.\n2. Have received prior treatment with ≥ 3 biologic therapies (including infliximab, adalimumab, vedolizumab, guselkumab, risankizumab, and mirikizumab), OR ≥ 2 biologic therapies plus 1 JAK inhibitor (including upadacitinib and tofacitinib).\n3. Have any condition that, in the investigator's judgment, may compromise data quality or threaten participant safety. The reason for exclusion must be documented.",{"count":486,"type":23},500,"Ulcerative colitis (UC) is a chronic inflammatory bowel disease that causes symptoms such as bloody diarrhea, abdominal pain, and frequent bowel movements. It can significantly affect patients' quality of life. Etrasimod is an oral medication taken once daily that has been shown in clinical trials to be effective for treating active UC. However, clinical trial results may not fully reflect how the drug works in real-world clinical practice, where patients have more diverse backgrounds and medical conditions.\n\nThis is a prospective, multicenter, observational registry study conducted at approximately 80 hospitals across China. The study will enroll about 500 Chinese adults with active UC who are receiving or about to start treatment with etrasimod. Participants will be followed for at least 52 weeks. The study does not assign any treatment-all participants receive etrasimod as part of their routine clinical care, and treatment decisions are made by their doctors.\n\nThe main goal of this study is to describe the characteristics of Chinese adults with active UC who are treated with etrasimod in real-world settings, including their age, sex, disease duration, disease activity, and prior treatments. The study will also track how UC symptoms change over time, how often disease flares occur, and how treatment is adjusted during follow-up. Additional goals include describing medication use patterns, changes in physician-assessed and patient-reported outcomes, treatment-related economic burden, and safety information including adverse events.\n\nData will be collected at baseline and at Weeks 2, 12, 24, and 52 through routine clinic visits, medical records, and patient questionnaires. The study will help provide a more complete understanding of how etrasimod performs in everyday clinical practice in China.",[29],[440,490],"Etrasimod","2026-07-09",{"date":420,"type":36},{"date":420,"type":23},{"date":495,"type":23},"2028-06-30",{"name":497,"class":99},"Tang-Du Hospital",{"id":499,"slug":500,"hasResults":12,"nctId":501,"briefTitle":502,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":518},"100611808","switching-to-the-il-23-inhibitor-guselkumab-for-people-with-active-ibd-who-previously-used-ustekinumab-shift-ibd-100611808","NCT07245394","Switching to the IL-23 Inhibitor Guselkumab for People With Active IBD Who Previously Used Ustekinumab (SHIFT-IBD)","SHIFT-IBD: Switching to High-efficacy Anti-IL-23 Guselkumab in Ustekinumab-exposed Persons With Active IBD","SHIFT-IBD","Inclusion Criteria:\n\n* Subjects of any gender aged ≥ 18.\n* Confirmed diagnosis of IBD (CD, UC, or IBDU) for at least 6 months prior to baseline visit. Subjects with IBDU will be grouped with subjects with UC. The CD proportion of patients will be capped at 75%.\n* Subjects have received ustekinumab for at least 14 weeks and who are currently on or recently discontinued ustekinumab therapy.\n* For subjects that have recently discontinued ustekinumab, the last dose of ustekinumab must have been within 12 weeks before Week 0, and no other advanced therapy (i.e., infliximab, adalimumab, golimumab, certolizumab pegol, vedolizumab, natalizumab, risankizumab, mirikizumab, tofacitinib, upadacitinib, ozanimod, etrasimod) was started since stopping ustekinumab.\n* Subjects with an inadequate response to ustekinumab who require a change in advanced therapy and are initiating guselkumab, as determined by the treating physician.\n* For subjects on off-label ustekinumab dosing (90 mg every 4 or 6 weeks (off-label dosing), enrollment will be capped at 60%.\n* Ability and willingness to give written informed consent and comply with the requirements of this study protocol.\n* Subjects who have evidence of ongoing endoscopic evidence of disease activity within 3 months prior to Week 0, defined as:\n\n  * For Crohn's Disease: Colonoscopy showing SES-CD score (excluding the presence of narrowing component) of ≥6 (or ≥4 for participants with isolated ileal disease), OR presence of ulcers larger than 5 mm in any segment.\n  * For Ulcerative Colitis: Colonoscopy showing Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≥4, OR presence of erosions or ulcers in any segment.\n\nExclusion Criteria:\n\n* History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab).\n* Subjects with formal contraindication to guselkumab per the drug label.\n* Use of guselkumab for an off-label indication, dosing regimen, or route of administration. Subjects who did not receive guselkumab induction will be excluded.\n* Subjects with an ostomy or ileo-anal pouch.\n* Subjects with a history of bowel surgery within 6 months prior to Week 0.\n* Subjects displaying clinical signs of acute severe UC, fulminant colitis or toxic megacolon within 3 months prior to Week 0.\n* Subjects who are expected to require bowel surgery by their IBD physician within the year of enrollment.\n* Subjects on 1 or more concomitant biologics.\n* Subjects with a history of colonic dysplasia (low-grade dysplasia, high-grade dysplasia, or colorectal cancer). Note: Patients with a history of indefinite for dysplasia would be eligible.\n* Subjects with formal contraindication or unwilling to undergo lower endoscopy.\n* The patient is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.",{"count":206,"type":23},"The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab.\n\nPatients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year.\n\nGuselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care.\n\nResearchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy.\n\nThe goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.",[213,413,29,509],"IBD-unclassified (IBD-U)","2026-07-07",{"date":491,"type":36},{"date":513,"type":36},"2026-01-29",{"date":515,"type":23},"2028-11-01",{"name":517,"class":99},"TIDHI Innovation Inc.",12,{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":527,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":24,"phases":530,"briefSummary":531,"conditions":532,"keywords":534,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":70},"100646509","phase-4-stopping-ppi-therapy-in-inactive-ibd-100646509","NCT07691138","Stopping PPI Therapy in Inactive IBD","STOpping PPI Therapy in Inactive IBD Study (STOP-IT): A Feasibility Study","STOP-IT","Inclusion Criteria:\n\n* Aged 16 years or older.\n* An IBD diagnosis as defined through SNOMED codes in primary care databases \\[Appendix 5\\]\n* Taking a PPI regularly for \\>6 months prior to enrolment\n* Patient-confirmed compliance with PPI therapy (\\>75% of prescribed doses)\n* Able to give full, independent valid Informed consent\n* Stable disease as defined by no change in medication or IBD-related surgery for the last 3 months.\n\nExclusion Criteria:\n\n* Unable to participate fully in all aspects of the clinical trial.\n* Barrett's oesophagus\n* Peptic disease at a recent upper GI endoscopy\n* Zollinger-Ellison Syndrome\n* Eosinophilic oesophagitis\n* Chronic NSAID usage\n* Pulmonary fibrosis.\n* Declined consent to data sharing\n* History of dementia\n* Terminal illness\n* Present malignancy\n* Active history of mental illness\n* In a care home\n* Alcohol misuse\n* Illicit drug misuse","16 Years",{"count":529,"type":23},80,[56],"To investigate the feasibility of proton pump inhibitor (PPI) withdrawal in inflammatory bowel disease (IBD); the data collected will provide valuable information to inform a future multi-centre randomised controlled trial.\n\nEvidence suggests that patients with IBD taking PPIs respond less well to medication and require hospital treatment more frequently than patients not taking PPIs. This may be due to changes in the gut microbiota associated with PPI use.\n\nA future definitive trial is planned to investigate clinical outcomes in patients who stop PPIs compared with those who continue PPIs, in order to determine the safety implications of PPI use in IBD. However, several uncertainties remain which require investigation before such a trial can be undertaken. It is currently unknown how many patients with IBD take PPIs, how many can successfully stop taking PPIs, how many would be willing to stop treatment, and how many would remain off treatment long term. In some cases, withdrawal of PPIs may result in a short-term increase in acid reflux symptoms. The willingness of patients to participate in such a study is also unknown. This study will be conducted in GP practices, a setting in which IBD trials have not previously been undertaken.\n\nThe study will recruit 80 participants with IBD aged 16 years and over who have been taking PPIs regularly for more than six months. Half of participants will be randomised to discontinue PPI therapy. Participants will be followed up for 12 months. The study will provide information regarding recruitment rates within GP practices, optimal methods for PPI withdrawal, and whether stopping PPIs affects IBD outcomes.",[29,533],"Crohn's Disease",[535,536,533,189,537],"proton pumb inhibitor","PPI","PPI Withdrawal","2026-07-06",{"date":540,"type":36},"2026-07-08",{"date":542,"type":23},"2026-07-01",{"date":544,"type":23},"2027-07-01",{"name":546,"class":99},"University of Nottingham",{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":107,"enrollmentInfo":555,"targetDuration":4,"studyType":24,"phases":557,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":567},"100646362","phase-1-a-phase-ibiia-study-of-int-210-capsules-in-participants-with-active-ulcerative-colitis-100646362","NCT07692165","A Phase Ib\u002FIIa Study of INT-210 Capsules in Participants With Active Ulcerative Colitis","A Multicenter, Randomized, Open-label Clinical Study to Evaluate the Safety and Efficacy of INT-210 Capsules in Participants With Active Ulcerative Colitis","INT-210-II102","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form (ICF);\n2. Males or females aged ≥18 and ≤75 years at the time of signing the ICF;\n3. Diagnosed with UC for ≥3 months at the time of signing the ICF, with the diagnosis of UC supported by clinical manifestations and colonoscopy evidence, and confirmed by a histopathology report (pre-randomization colonoscopy and histopathology examination are acceptable as supporting evidence);\n4. Active UC, defined as: a modified Mayo score (including hematochezia, stool frequency, and endoscopy findings) of 4-9, with an endoscopy subscore of ≥2 (confirmed by central reading) and a hematochezia subscore of ≥1 in the Mayo score;\n5. At pre-randomization colonoscopy, the extent of UC lesions extends beyond the rectum (active disease ≥15 cm from the anal verge on colonoscopy, confirmed by central reading);\n6. Participants must have had an inadequate response or intolerance to at least one of the following UC treatments (inadequate response is defined as that the participant has previously discontinued the corresponding drug due to lack of efficacy as judged by the investigator; intolerance is defined as that the participant has previously discontinued the drug due to adverse reactions as judged by the investigator): oral sulfasalazine (SASP) and\u002For 5- aminosalicylate (5-ASA); oral corticosteroids; azathioprine or 6- mercaptopurine; marketed anti-tumor necrosis factor-α (TNF-α) agents: infliximab or adalimumab, etc.; vedolizumab; marketed JAK inhibitors: tofacitinib, upadacitinib, etc.; marketed interleukin 12\u002F23 (IL-12\u002F23) inhibitors: ustekinumab, etc.; selective sphingosine-1-phosphate (S1P) receptor modulators: etrasimod, etc.; sulfasalazine (SASP) and\u002For 5- aminosalicylate (5-ASA); oral corticosteroids; azathioprine or 6- mercaptopurine; marketed anti-tumor necrosis factor-α (TNF-α) agents: infliximab or adalimumab, etc.; vedolizumab; marketed JAK inhibitors: tofacitinib, upadacitinib, etc.; marketed interleukin 12\u002F23 (IL-12\u002F23) inhibitors: ustekinumab, etc.; selective sphingosine-1-phosphate (S1P) receptor modulators: etrasimod, etc.;\n7. If participants are currently using the following drugs to treat UC, they must also meet the following requirements:\n\n   * Glucocorticoid therapy: oral prednisone ≤20 mg\u002Fd (or equivalent drug dose) or budesonide ≤9 mg\u002Fd or beclomethasone ≤5 mg\u002Fd, with a stable dose for at least 2 weeks before the screening colonoscopy;\n   * Aminosalicylate preparations: oral sulfasalazine and\u002For 5- aminosalicylate must be stable for at least ≥2 weeks before the screening colonoscopy and must remain stable during the study;\n8. Throughout the entire study period from the signing of the ICF and for 3 months after the last dose, female participants of childbearing potential and male participants who have not undergone vasectomy must comply with the specified contraception requirements.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, or those planning to become pregnant during the study;\n2. Known allergy to any component of INT-210;\n3. Based on medical history and endoscopy and\u002For histological results, participants with suspected or confirmed Crohn's disease, unclassified colitis, acute fulminant colitis, toxic megacolon, intestinal perforation, microscopic colitis, ischemic colitis, or radiation colitis;\n4. Participants who have undergone surgery for UC or are planning surgery (including stoma creation, or total or partial proctectomy\u002Fcolectomy, etc.);\n5. Evidence of unresected adenoma or dysplasia in the colon, including lowgrade or high-grade atypical hyperplasia, and unclassified atypical hyperplasia; presence of high-risk progressive adenoma, defined as:\n\n   ① Adenoma diameter ≥10 mm; or ② Villous adenoma or mixed adenoma with villous structure exceeding 25%; or ③ Accompanied by high-grade intraepithelial neoplasia.\n6. With primary sclerosing cholangitis;\n7. History of alcohol or drug abuse or addiction within one year prior to screening;\n8. Have undergone other major surgery within 6 months prior to screening, or are planning surgery during the study; have a history of myocardial infarction, acute stroke or transient ischemic attack, thrombotic events such as deep vein thrombosis or pulmonary embolism, clinically significant arrhythmia or unstable angina pectoris, coronary artery bypass grafting, or severe or pulmonale or pulmonary arterial hypertension that would affect the evaluation of study results, within 6 months prior to screening;\n9. Presence of clinically severe diseases, such as a history of cardiovascular, hepatic, endocrine, gastrointestinal, metabolic, neurological, pulmonary, or psychiatric diseases, or clinically significant diseases, conditions, or other evidence that the investigator considers would pose a risk to participant safety or interfere with the conduct, progress, or completion of the study;\n10. Have received two or more classes of biological products\u002Fsmall molecule targeted drugs (e.g., anti-TNF-α monoclonal antibodies, anti-integrin antibodies, anti-IL12\u002F23 monoclonal antibodies, JAK inhibitors, S1P receptor modulators) and have been assessed by the investigator as treatment failure (UC disease progression requiring salvage therapy, inability to taper glucocorticoid during the maintenance phase, or need for other effective therapies);\n11. Participants receiving the following drug therapies:\n\n    * Use of non-steroidal anti-inflammatory drugs (excluding stable use of\n\n      ≤100 mg\u002Fday aspirin for prevention of cardiovascular and cerebrovascular diseases and temporary use of ≤2000 mg\u002Fday acetaminophen for no more than three days for infectious pyrexia or mild to moderate pain), intestinal probiotics (including fecal transplant), fish oil, JAK inhibitors, immunoadsorption therapy, Chinese herbal medicines, or compound preparations containing Chinese herbal medicines within 2 weeks prior to randomization;\n    * Use of azathioprine or 6-mercaptopurine, cyclosporine, thalidomide, methotrexate, mycophenolate, tacrolimus\u002Fsirolimus within 4 weeks prior to randomization;\n    * Use of intravenous corticosteroids within 4 weeks prior to randomization, or rectal corticosteroids or rectal 5-ASA within 2 weeks prior to randomization;\n    * Use of interferon or TNF-α inhibitors within 8 weeks prior to randomization;\n    * Intravenous immunoglobulin injection or therapeutic plasma exchange within 8 weeks prior to randomization;\n    * Use of S1P receptor modulators within 10 weeks prior to randomization;\n    * Use of vedolizumab, IL-12\u002F23 antibodies, cyclophosphamide, or chlorambucil within 12 weeks prior to randomization;\n    * Use of leflunomide within 12 weeks prior to randomization, unless discontinued for 4 weeks before randomization and accelerated elimination (e.g., oral cholestyramine or activated charcoal) was completed at least 2 weeks prior to randomization, with corresponding medical history records required;\n    * Use of rituximab within 1 year prior to randomization;\n    * Use of any other investigational or marketed products with immunosuppressive effects within 8 weeks or 5 drug half-lives (whichever is longer) prior to randomization;\n12. Positive for Mycobacterium tuberculosis or judged by the investigator to have a potential M. tuberculosis infection, such as: positive T-SPOT.TB test or purified protein derivative (PPD) induration ≥5 mm (within 3 months prior to screening); chest imaging within 3 months prior to screening suggesting active tuberculosis infection lesions;\n13. History of recurrent invasive fungal infections or other chronic infections; herpes zoster or cytomegalovirus infection within 8 weeks prior to signing the ICF; clinically diagnosed clostridioides difficile infection or other intestinal infections within 30 days before the screening colonoscopy; positive clostridium test result during the screening period; infection requiring systemic anti-pathogen drugs (including antibacterial, antiviral, antifungal, anti-parasitic, etc.) for control within 7 days prior to randomization;\n14. Presence of any disease that may require treatment with systemic glucocorticoid during the study (e.g., moderate to severe asthma, dermatitis atopic, rheumatoid arthritis, etc.);\n15. Malignant tumors within 5 years prior to screening (except for adequately treated or resected basal cell or squamous cell skin cancer); or previous neoplasm screening that did not rule out tumor lesions;\n16. Participants with conditions that may affect the absorption of oral drugs, such as gastrectomy or clinically significant diabetes mellitus-related gastrointestinal diseases, or specific types of obesity surgery such as gastric bypass; participants who have only undergone simple gastric banding-like procedures that divide the stomach into separate pouches are not excluded;\n17. Participants who have undergone small intestine or colon operation and have evidence of colonic dysplasia or intestinal stenosis;\n18. Any of the following abnormalities in screening laboratory tests:\n\n    * Hemoglobin \\\u003C9 g\u002FdL or white blood cells \\\u003C3.0×109\u002FL or neutrophils \\\u003C1.5×109\u002FL, platelets \\\u003C100×109\u002FL\n    * Total bilirubin (TBIL), aspartate transaminase (AST), or alanine transaminase (ALT) ≥1.5 times the upper limit of normal (ULN)\n    * Blood creatinine \\>1.5 times ULN\n    * Any other abnormal laboratory test results that the investigator considers may expose the participant to unacceptable risks by participating in this study\n    * Positive for hepatitis B surface antigen (HBsAg), or test results are HBsAg negative, hepatitis B core antibody (HBcAb) positive, and positive for hepatitis B virus deoxyribonucleic acid (HBV-DNA); positive for hepatitis C virus antibody (HCV-Ab) and positive for hepatitis C virus ribonucleic acid (HCV-RNA); positive for human immunodeficiency virus (HIV) antibody\n    * Positive for intestinal pathogens (excluding colonizing microorganisms interpreted by the investigator to be non-pathogenic);\n19. Clinically significant electrocardiogram abnormal during the screening period, which the investigator judges may increase the participant's safety risk;\n20. Have received any live vaccine within 3 months prior to randomization or plan to receive any live vaccine during the clinical study;\n21. Participants whom the investigator considers have other factors that make them unsuitable for participation in this study.",{"count":556,"type":23},24,[161,26],"A Multicenter, Randomized, Open-label Clinical Study to Evaluate the Safety and Efficacy of INT-210 Capsules in Participants with Active Ulcerative Colitis.\n\nThe study aims to evaluate the safety, efficacy, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics of INT-210 in participants with active ulcerative colitis (UC).",[29],"2026-07-02",{"date":491,"type":36},{"date":563,"type":36},"2026-06-11",{"date":195,"type":23},{"name":566,"class":43},"Innatus Therapeutics (Shanghai) Co., Ltd.",15,{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":156,"sex":18,"minAge":576,"maxAge":4,"enrollmentInfo":577,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":148},"100646737","ibd-biomarker-discovery-and-validation-platform-100646737","NCT07686406","IBD Biomarker Discovery and Validation Platform","Biomarker Discovery, Validation, and Multi-Omics Profiling for Disease Activity Assessment, Treatment Monitoring, and Risk Stratification in Inflammatory Bowel Disease: A Multicenter Prospective Biospecimen-Based Observational Cohort Study","IBD-BIOP","Eligibility Criteria:\n\nInclusion Criteria:\n\n1. General inclusion criteria for all participants:\n\n   * Age 14 years or older.\n   * Able to provide written informed consent; for minors, consent from a legal guardian and assent from the participant will be obtained according to local ethics requirements.\n   * Willing to provide clinical information and\u002For biospecimens, which may include blood, stool, intestinal tissue, or other available biological samples.\n   * Able to participate in study-related data and sample collection according to the study protocol.\n2. Participants with inflammatory bowel disease:\n\n   * Diagnosed with inflammatory bowel disease, including Crohn's disease, ulcerative colitis, or IBD-unclassified when applicable, according to accepted national or international diagnostic criteria.\n   * May be newly diagnosed, previously diagnosed, under routine follow-up, or receiving routine clinical treatment.\n   * Clinical data, treatment exposure information, laboratory results, endoscopic findings, histologic findings, imaging findings, biospecimens, and follow-up outcomes may be available or collected.\n3. Unaffected first-degree relatives of participants with inflammatory bowel disease:\n\n   * Biological first-degree relatives of participants with inflammatory bowel disease, including parents, siblings, or offspring.\n   * No prior diagnosis of inflammatory bowel disease at enrollment.\n   * Willing to provide clinical information and\u002For biospecimens for family-based genetic, environmental, immune, microbiome, and multi-omics analyses.\n4. Unrelated healthy controls:\n\n   * Individuals without a diagnosis of inflammatory bowel disease.\n   * No first-degree biological relationship to enrolled participants with inflammatory bowel disease.\n   * No known active gastrointestinal inflammatory disease at enrollment.\n5. Non-IBD disease controls:\n\n   * Individuals with gastrointestinal symptoms or other non-IBD conditions who undergo clinical evaluation but are not diagnosed with inflammatory bowel disease.\n   * Clinical information and\u002For biospecimens may be collected as disease controls when appropriate.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent or required assent when applicable.\n* Active severe infection or chronic infectious disease that may substantially affect biomarker interpretation, including active tuberculosis, active hepatitis B or C, HIV infection, or other clinically significant active infection.\n* Pregnancy or lactation at the time of enrollment.\n* Severe mental illness, cognitive impairment, or other condition that prevents cooperation with study procedures.\n* Known primary extraintestinal autoimmune disease or systemic inflammatory disease that is considered the main disease and may substantially confound biomarker interpretation.\n* Current or recent participation in another interventional clinical trial that may substantially affect the study biomarkers or outcome assessments, as judged by the investigator.\n* History of malignant tumor or other severe comorbidity that may substantially affect study participation or biomarker interpretation, as judged by the investigator.\n* Inadequate biospecimen quality, missing key clinical information, or inability to complete essential study assessments for the relevant analysis.","14 Years",{"count":578,"type":23},6000,"The goal of this observational study is to establish a multicenter prospective clinical and biospecimen platform for biomarker discovery and validation in inflammatory bowel disease, including Crohn's disease and ulcerative colitis.\n\nResearchers want to learn whether candidate biomarkers or combined biomarker models can help assess intestinal inflammation, monitor response to routine clinical treatment, predict treatment outcomes, and identify participants who may be at higher risk of disease progression.\n\nThe study may enroll participants with inflammatory bowel disease, unaffected first-degree relatives of participants with inflammatory bowel disease, unrelated healthy controls, and non-IBD disease controls when appropriate. Clinical information and biological samples, including blood, stool, and intestinal tissue, may be collected. Biomarkers measured in blood, stool, intestinal tissue, genetic data, immune profiles, microbiome data, and other multi-omics data may be evaluated.\n\nThe main questions this study aims to answer are:\n\nCan candidate biomarkers or combined biomarker models identify endoscopic disease activity when compared with endoscopic assessment?\n\nCan these biomarkers monitor or predict clinical response, clinical remission, endoscopic response, endoscopic remission, imaging response, or biomarker response during routine clinical care?\n\nCan these biomarkers help predict treatment failure, disease progression, hospitalization, surgery, treatment escalation, or complex Crohn's disease phenotypes?\n\nParticipants will not be assigned to any treatment by the study. All treatments and clinical management decisions will be chosen by treating physicians as part of routine medical care.",[413,29,581],"Inflammatory Bowel Diseases (IBD)",[583,584,585,586,587,588,589,590,591,592,593,594,595,596,597],"Biomarker discovery","Biomarker validation","Prospective observational cohort Disease activity","Endoscopic activity","Histologic activity","Treatment monitoring","Treatment response","Risk stratification","Disease progression","Leucine-rich alpha-2 glycoprotein","Fecal calprotectin","Oncostatin M","TL1A","TNFSF15","Multi-omics","2026-06-28",{"date":510,"type":36},{"date":601,"type":36},"2022-01-01",{"date":603,"type":23},"2028-12-31",{"name":311,"class":99},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":610,"eligibilityCriteria":611,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":612,"targetDuration":4,"studyType":208,"phases":4,"briefSummary":614,"conditions":615,"keywords":616,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100642703","prospective-evaluation-of-flare-detection-in-ibd-with-digital-biomarkers-bring-your-own-device-study-100642703","NCT07647640","Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study","BYOD","Inclusion Criteria:\n\n* 18 years or older\n* Crohn's Disease or ulcerative colitis\n* Having a smartwatch and\u002For a smartphone\n* Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)\n\nExclusion Criteria:\n\n* No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...",{"count":613,"type":23},600,"The aim of this study is to identify HRV changes predictive of IBD flares using patient-own wearable devices in a large cohort supplemented by additional data layers including sleep parameters, step count and clinical data extracted from electronic patient files.",[213,29,413],[390,617,618],"Digital biomarkers","Heart rate variability","2026-06-24",{"date":621,"type":36},"2026-06-29",{"date":623,"type":23},"2026-06-15",{"date":625,"type":23},"2027-10-15",{"name":627,"class":99},"Maastricht University Medical Center",3]