[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colitis":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,69,92,131,180,203,231,293,315,339],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634559","a-real-world-study-of-guselkumab-in-ulcerative-colitis-and-crohns-disease-in-saudi-arabia-100634559",false,"NCT07541261","A Real-World Study of Guselkumab in Ulcerative Colitis and Crohn's Disease in Saudi Arabia","A Multi-Center, Non-Interventional Study on Effectiveness and Treatment Persistence of Guselkumab in Patients With ULcerative Colitis and Crohn's DiseasE in Real-World Practice in Saudi Arabia","EAGLE","Inclusion Criteria:\n\n* The participant must be eligible for biologic treatment and initiate guselkumab according to the approved indications described in the current version of the summary of product characteristics (SmPC) approved in Saudi Arabia. The decision to prescribe must solely be made by the treating physician. Enrollment must take place before or at the day of first administration of guselkumab (but after treatment decision by physician) and after obtaining patient consent\n* The participant must have a confirmed diagnosis of moderate-to-severe CD or UC recorded in their medical records\n* The participant must sign a participation agreement\u002Finformed consent form (ICF) allowing source data verification\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to Interleukin (IL)-23 inhibitors, including tremfya (guselkumab), skyrizi (risankizumab) and omvoh (mirikizumab). As an exception, participants with history of ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and\u002For small molecules)\n* Is unable to provide informed consent","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","OBSERVATIONAL","The main purpose of this study is to evaluate treatment persistence of guselkumab (that is how long a person keeps taking their prescribed medicine or continues with their treatment plan without stopping) in participants with moderate to severe crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are Inflammatory bowel disease, a group of inflammatory conditions of the colon and small intestine.",[25,26,27],"Colitis","Ulcerative","Crohn Disease","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2026-05-12",{"date":36,"type":21},"2029-01-29",{"name":38,"class":39},"Janssen Research & Development, LLC","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100593896","phase-2-a-study-of-long-acting-antibodies-alone-and-in-combinations-for-moderate-to-severe-ulcerative-colitis-100593896","NCT07012395","A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis","Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis","SKYLINE-UC","Inclusion Criteria:\n\n* Diagnosis of UC for ≥3 months before Day 1, confirmed by endoscopy and histology either previously or during Screening\n* Active UC with disease extent of ≥15 cm from the anal verge, as confirmed by Screening endoscopy (up to approximately 15% allowed to have only proctitis)\n* Moderately to severely active disease as defined by a modified Mayo score of 5-9, rectal bleeding subscore of ≥1, and Mayo endoscopic subscore ≥2\n\nExclusion Criteria:\n\n* Current diagnosis of Crohn's disease or Inflammatory Bowel Disease (IBD)-Undefined\n* Confirmed or suspected fulminant colitis, toxic megacolon, bowel perforation and\u002For other conditions that will likely require surgery during induction\n* Failed 4 or more approved or investigational advanced therapy classes",{"count":50,"type":21},645,"INTERVENTIONAL",[53],"PHASE2","This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC). The primary goal of the study is to assess the efficacy and safety of multiple interventions following intravenous (IV) induction and subcutaneous (SC) maintenance treatment.",[56,57,25,58],"Ulcerative Colitis","Inflammatory Bowel Diseases","Colitis, Ulcerative","2026-06-26",{"date":61,"type":32},"2026-06-29",{"date":63,"type":32},"2025-05-27",{"date":65,"type":21},"2028-03",{"name":67,"class":39},"Spyre Therapeutics, Inc.",243,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":51,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100495070","phase-2-a-pilot-study-testing-the-safety-and-feasibility-of-restorative-microbiota-therapy-rmt-in-patients-with-refractory-immune-checkpoint-inhibitor-related-colitis-100495070","NCT05726396","A Pilot Study Testing the Safety and Feasibility of Restorative Microbiota Therapy (RMT) in Patients With Refractory Immune-checkpoint Inhibitor-related Colitis","Inclusion Criteria:\n\n* Localized, locally advanced or metastatic solid tumors who have received at least two doses of ICI (PD-1\u002FPD-L1 with or without CTLA-4 inhibitor).\n* ICI used as a single agent, or combination or ICI in combination with other cytotoxic chemotherapy or targeted therapy for curative or palliative intent treatment.\n* Last ICI treatment with in 6 weeks of onset of IMDC symptoms\n* Meet one of the criteria for steroid refractory IMDC defined as:\n\n  1. Persistent symptoms (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) following high-dose corticosteroid therapy (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) for least 48 hours or\n  2. Persistent symptoms (ongoing Grade ≥ 2 diarrhea per CTCAE v5.0.) following use of a one or more biologic agent (i.e. either a TNFα inhibitor or an anti-integrin) in addition to corticosteroids (with starting dose of prednisone or equivalent ≥1 mg\u002Fkg\u002Fday for at least 48 hours followed by receipt of at least one dose of either a TNFα inhibitor or an anti- integrin for at least 48 hours or\n  3. For patients with relapsed IMDC who have discontinued steroids: Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) within 4 weeks of discontinuing prednisone or equivalent. These patients should have received initial high-dose corticosteroid therapy (˃1 mg\u002Fkg\u002Fday prednisone or equivalent) with subsequent taper over at least 4 weeks or\n  4. For patients with relapsed IMDC following the tapering of steroids Relapsed IMDC symptoms for 24 or more hours (NCI CTCAE v 5.0 Grade ≥ 2 diarrhea) while the prednisone taper is on-going. These patients should have received initial high-dose corticosteroid therapy (˃1 mg\u002Fkg\u002Fday prednisone or equivalent) with resulting clinical resolution of diarrhea (NCI CTCAE v 5.0 Grade ˂ 1 diarrhea) for at least 24 hours before relapse\n* Adequate organ function within 14 days prior to study enrollment defined as:\n\n  1. Hematology: Hemoglobin ≥9.0 g\u002FdL, absolute neutrophil count (ANC) ≥1,000\u002FmcL, platelets ≥75,000\u002FmcL,\n  2. Hepatic function: Total bilirubin ≤ 1.5x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤5x ULN)\n  3. Renal function: measured creatinine clearance \\>40 mL\u002Fmin or estimated glomerular filtration rate (GFR) \\>40 mL\u002Fmin If AST\u002FALT and serum creatinine elevation are suspected to be irAEs, patients are eligible as long as the irAE are controlled (i.e. not getting worse at the time of enrollment)\n* Well controlled diabetes with HbA1c of \\\u003C8 with in 6 months of screening\n* Euvolemic on physical examination\n* Stable vital signs at screening and enrollment that includes\n\n  1. Body temperature 95.8 to 99.9°F\n  2. Heart rate between 60-100\u002Fmin\n  3. Blood pressure 90-140\u002F60-90 mm of Hg.\n* Must be on standard antidiarrheal supportive care for at least 1 day prior to starting RMT. The regimen consists of: loperamide 2-4 mg every 6 hours (up to 16 mg \u002Fday) and\u002For diphenoxylate 5 mg\u002F atropine sulfate 0.05 mg (2 tabs or 10 ml) up to 4 times daily as needed. This will continue until resolution of diarrhea to NCI CTCAE v 5.0 Grade ≤ 1.\n* Age 18 years of age or older at the time of consent\n* Body weight of \\>30 kg\n* Expected survival for at least 6 months in the opinion of the enrolling investigator as documented in the medical record\n* Voluntary written consent prior to the performance of any research related activity.\n\nExclusion Criteria:\n\n* Diagnosis of concomitant infectious colitis based on standard stool screening including stool microscopy for ova and parasites, stool PCR for Clostridioides difficile, and locally available common enteric bacterial pathogen and viral panel by PCR.\n* Last cytotoxic chemotherapy or targeted therapy less than 3 week prior to screening\n* Patients anticipated to require cytotoxic chemotherapy or targeted therapy through the end of treatment EOT period (30 days following first dose of RMT)\n* Known current pregnancy or breastfeeding.\n* Receiving another investigational agent or has received an investigational agent within 60 days of study enrollment.\n* Any other uncontrolled Grade ≥3 infection at the time of enrollment (Concomitant systemic antibiotics for non-GI infections are allowed).\n* Previous documented history of chronic diarrhea from non-IMDC causes (For example: inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n* Known dysphagia or inability to swallow study capsules (CTCAE v5 Dysphagia Grade ≥2 - symptomatic and altered eating\u002Fswallowing).\n* Known risk of aspiration based on history or current complaints.\n* Has a known sensitivity to any component of therapeutic agents used in this study.\n* On intravenous biologic agents for other baseline autoimmune conditions.\n* Other concomitant uncontrolled irAE's at the time of enrollment which would require systemic corticosteroids or biologic immunomodulatory agents.\n* On chronic systemic antibiotic therapy (antibiotics for ≥60 consecutive days within 12 weeks of enrollment).\n* Receipt of over-the-counter probiotics in the last 4 weeks\n* Receipt of live attenuated vaccination within 30 days of receiving RMT. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chickenpox (except shingrix), yellow fever, nasal seasonal flu, nasal H1N1 flu, rabies, BCG, and typhoid - COVID-19 vaccination is permitted.\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent.",{"count":76,"type":21},20,[53],"Immune-related colitis from immune checkpoint inhibitors (ICI) is a common adverse effect causing significant morbidity and impairment of quality of life (QoL). Steroids are the first line of treatment for severe ICI induced Immune- mediated diarrhea and colitis (IMDC). If there is no improvement in 48 to 72 hours, other immunosuppressive agents (infliximab, vedolizumab) are recommended. However, efficacy data supporting the use of immunosuppressives for steroid refractory IMDC is limited by case reports\u002Fseries. Clinical trials focusing on steroid-refractory colitis are sparse. Novel treatments for IMDC outside of blanket immunosuppression are needed. There is robust evidence to suggest that gut microbial diversity and composition is associated with both ICI efficacy and toxicity. Preliminary studies have shown that pathophysiology of immune mediated colitis may be related to loss of gut microbial diversity. Recently, multiple case series have shown the utility of fecal microbiota transplant for treatment of refractory IMDC providing the proof of concept. This is a pilot randomized placebo controlled study to assess the safety and feasibility of oral restorative microbiota therapy (RMT) in patients with steroid- refractory IMDC.",[80,25],"Immune-related Colitis","2026-06-08",{"date":83,"type":32},"2026-06-10",{"date":85,"type":32},"2025-09-23",{"date":87,"type":21},"2027-02-01",{"name":89,"class":90},"University of Minnesota","OTHER",9,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":51,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":129,"locationsCount":40},"100643523","aim-ibd-a-microbiome-targeted-supplement-in-mild-to-moderate-ulcerative-colitis-100643523","NCT07619638","AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis","AIM-IBD: A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of a Microbiome-Targeted Food Supplement Versus Placebo in Adults With Mild-to-Moderate, Objectively Active Ulcerative Colitis","AIM-IBD","Inclusion Criteria:\n\n1. Adults aged 18 to 75 years inclusive at screening.\n2. Documented diagnosis of ulcerative colitis established at least 3 months before screening, based on standard clinical, endoscopic, and histologic criteria.\n3. Mild-to-moderate active ulcerative colitis defined by a partial Mayo score of 4 to 8 at screening.\n4. Rectal bleeding subscore of at least 1 at screening.\n5. Objective intestinal inflammation defined by fecal calprotectin of at least 250 micrograms per gram at screening, measured by the central laboratory or by a validated harmonized assay.\n6. Eligible disease extent: left-sided colitis or extensive\u002Fpancolitis. Proctosigmoiditis is eligible if inflammation extends beyond isolated proctitis and is measurable by study endoscopy. Isolated ulcerative proctitis (E1 only) is eligible only within a prespecified cap not exceeding 10 percent of total enrollment.\n7. Either no current ulcerative colitis-directed therapy, or stable oral and\u002For rectal 5-aminosalicylate (5-ASA, mesalamine) therapy at unchanged dose for at least 8 weeks before randomization, with intent to continue at the same unchanged dose through Week 24 unless rescue therapy is clinically required.\n8. Able and willing to provide written informed consent.\n9. Able and willing to comply with study visits, stool sampling, endoscopy, medication restrictions, and diary\u002Fpatient-reported outcome completion.\n10. Participants of childbearing potential must agree to use a highly effective method of contraception during dosing and for at least 4 weeks after the last dose, in accordance with EMA\u002FCTFG guidance and local ethics requirements.\n\nExclusion Criteria:\n\n1. Crohn disease, inflammatory bowel disease-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or any other non-ulcerative-colitis form of colitis.\n2. Severe ulcerative colitis, acute severe ulcerative colitis, fulminant colitis, toxic megacolon, or any disease severity requiring immediate hospitalization or treatment escalation in the investigator's judgment.\n3. Isolated ulcerative proctitis (E1 only) outside the prespecified 10 percent enrollment cap.\n4. Use of biologics, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor modulators, or systemic immunosuppressants within 8 weeks before randomization, or planned use of any of these during the trial.\n5. Systemic corticosteroids within 4 weeks before randomization.\n6. Current budesonide-class therapy at baseline.\n7. Rectal or topical corticosteroids unless discontinued at least 2 weeks before randomization.\n8. Antibiotic use within 4 weeks before randomization, except topical antibiotics not expected to affect the gut microbiota.\n9. Probiotic, prebiotic, synbiotic, postbiotic, fermented microbiome-directed supplement, or other non-study microbiome-directed product within 4 weeks before randomization, or planned use during the trial.\n10. Active or recent Clostridioides difficile infection within 12 weeks before screening (screening uses a two-step algorithm: glutamate dehydrogenase plus toxin A\u002FB enzyme immunoassay, with reflex nucleic acid amplification testing for discordant results).\n11. Positive stool test for any clinically relevant enteric infection at screening, per local diagnostic standard operating procedures.\n12. Prior colectomy, planned colectomy, known dysplasia requiring intervention, or colorectal cancer.\n13. Pregnancy, breastfeeding, or planned pregnancy during the trial.\n14. Uncontrolled clinically significant comorbidity, including but not limited to uncontrolled diabetes, advanced liver or renal disease, unstable cardiovascular disease, immunodeficiency, active malignancy other than adequately treated non-melanoma skin cancer, or any other condition compromising participant safety or interpretation of study results.\n15. Known allergy, intolerance, or contraindication to any component of the investigational product or matching placebo.\n16. Participation in another interventional clinical trial within 30 days before screening.\n17. Any other condition that, in the investigator's judgment, would make participation unsafe or compromise protocol adherence.","75 Years",{"count":102,"type":21},162,[104],"NA","This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with mild-to-moderate, objectively active ulcerative colitis. The supplement is food-grade and is intended for use either alongside stable standard ulcerative colitis therapy (5-aminosalicylic acid\u002Fmesalamine) or in participants not currently on any inflammatory bowel disease therapy.\n\nApproximately 162 participants will be enrolled at university hospital centers in Turkey and randomized in a 1:1 ratio to receive either the food supplement or matching placebo for 24 weeks, in addition to their existing background therapy as defined by eligibility.\n\nThe primary objective is to determine whether the supplement increases the proportion of participants achieving composite clinical-plus-biochemical remission at Week 24. This composite endpoint requires absence of rectal bleeding, improvement in stool frequency, fecal calprotectin ≤250 micrograms\u002Fg, and no rescue therapy, prohibited treatment escalation, ulcerative colitis-related hospitalization, colectomy, or discontinuation for lack of efficacy before Week 24.\n\nKey secondary endpoints include endoscopic improvement, deep biochemical remission, change in fecal calprotectin, change in partial Mayo score, corticosteroid-free composite remission, change in quality of life, change in C-reactive protein, time to treatment failure, and safety. Exploratory analyses will assess stool microbiome composition, eukaryotic carriage including Blastocystis, and associations between baseline microbiome features and treatment response.",[107,108,25],"Ulcerative Colitis (UC)","Inflammatory Bowel Disease (IBD)",[110,111,112,113,114,115,116,117,118,119,120,121,122],"Ulcerative colitis","Inflammatory bowel disease","Microbiome","Gut microbiota","Fecal calprotectin","Artificial intelligence","Partial Mayo score","5-ASA","Mesalamine","Nutraceutical","Placebo-controlled trial","Blastocystis","Microbiome-targeting nutraceutical","2026-06-05",{"date":125,"type":32},"2026-06-09",{"date":83,"type":21},{"date":128,"type":21},"2027-11-30",{"name":130,"class":39},"ENBIOSIS BIOTECHNOLOGIES",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":51,"phases":141,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100641002","phase-2-phoenix-ecp--extracorporeal-photopheresis-for-immune-related-colitis-andor-hepatitis-in-advanced-melanoma-with-inadequate-response-to-steroid-exposure-100641002","NCT07619898","PHOENIX-ECP- Extracorporeal Photopheresis for Immune-related Colitis and\u002For Hepatitis in Advanced Melanoma With Inadequate Response to Steroid Exposure","PHOENIX- A Phase 2, Randomized, Controlled, Open-label, Multicenter Study to Evaluate the Efficacy and Safety\u002FTolerability of Extracorporeal Photopheresis (ECP) Versus Best Available Therapy (BAT) for the Treatment of Immune-related Colitis or Hepatitis With Inadequate Response to Corticosteroids in Participants With Unresectable or Metastatic Melanoma Treated With Immune Checkpoint Inhibitors (ICI)","PHOENIX-ECP","Inclusion Criteria:\n\n1. Participants diagnosed with unresectable or metastatic melanoma ( Stage III and Stage IV) received ICI treatment (e.g., anti-PD-1, anti-PD-L1, anti-LAG-3, anti-CTLA-4 antibody, as ICI monotherapy or ICI combination therapy) and ICI paused or discontinued because of the development of ir-colitis or ir-hepatitis.\n2. Participants diagnosed with ir-colitis and\u002For ir-hepatitis with a severity of Grade 2 or higher, based on ASCO Guidelines (\n3. Participants with endoscopic evidence of ir-colitis\n4. Participants with inadequate response to corticosteroids, as defined per protocol\n5. Participants who have Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.\n\nExclusion Criteria:\n\n1. Presence of irAEs in addition to and other than ir-colitis and\u002For ir-hepatitis, with a higher severity grade than the irAE for inclusion (ir-colitis\u002Fir-hepatitis) based on ASCO guidelines.\n2. Participant has a diagnosis of uveal melanoma as the sole melanoma subtype\n3. Treatment of ir-colitis or ir-hepatitis with any systemic therapy other than corticosteroids\n4. Concurrent conditions which may require treatment with high dose corticosteroid (\\> 1 milligram per kilogram per day \\[mg\u002Fkg\u002Fday\\]) and interfere with the corticosteroid tapering schedule recommended by the protocol.\n5. Pre-existing liver disease\n6. Active alcohol use disorder\n7. Concomitant treatment with any chemotherapy or targeted therapy for the treatment of unresectable or metastatic melanoma.\n8. Use of any investigational agent within 5 half-lives of the investigational agent prior to randomization.\n9. Contraindications or known allergic reaction to any of study intervention and\u002For procedures\n10. Participants unable to tolerate the fluid shift associated with the ECP procedure.\n11. Positive result for active or previous viral infections: covid-19, hepatitis B\u002FC, CMV, EBV, adenovirus\n12. History of previous or concurrent malignancies within the last 3 years, other than unresectable or metastatic melanoma.",{"count":140,"type":21},112,[53],"Extracorporeal photopheresis (ECP) is an immunomodulatory therapy in which the photoactivating agent methoxsalen (also known as UVADEX) is used in combination with ultraviolet A (UVA) light.\n\nImmune checkpoint inhibitor therapy is widely used for the treatment of several cancers, including melanoma. However, a common immune-related adverse event associated with this therapy is Immune-related colitis or hepatitis. Corticosteroids are typically the first-line treatment for this condition, but some participants do not respond adequately.\n\nThe purpose of this study is to evaluate the efficacy of ECP in the treatment of immune-related (ir)-colitis and ir-hepatitis with inadequate response to corticosteroids, and to compare its efficacy to other second-line immunosuppressant therapies. The ECP procedure in this study is performed using the CELLEX® device, a fully closed-loop extracorporeal blood circulation device. The CELLEX device is used in conjunction with methoxsalen.",[25,144,145],"Hepatitis","Melanoma (Skin Cancer)",[147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,25,167,168,169],"Melanoma","Immune-related adverse events","Immune-related colitis","Immune checkpoint inhibitor toxicity","Checkpoint inhibitor-induced colitis","Checkpoint inhibitor-induced hepatitis","Metastatic melanoma","Unresectable melanoma","Immune checkpoint Inhibitors","Extracorporeal photopheresis","ECP","UVADEX","Device","Methoxsalen","Steroid-refractory","Corticosteroid refractory","Phase 2 clinical trial","Randomized controlled trial","Cellex","8-Mop","Ir-AE","Ir-AE Colitis","Ir-AE Hepatitis","NOT_YET_RECRUITING","2026-05-27",{"date":173,"type":32},"2026-06-02",{"date":175,"type":21},"2026-07",{"date":177,"type":21},"2029-12",{"name":179,"class":39},"Therakos LLC",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":51,"phases":189,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":40},"100608042","phase-1-kan-004-for-immune-related-diarrhea-or-colitis-100608042","NCT07196410","KAN-004 for Immune-Related Diarrhea or Colitis","A Phase I Study of KAN-004 in Patients With Immune-Related Diarrhea or Colitis","Inclusion Criteria:\n\n* Diagnosis of solid tumor treated with immune checkpoint inhibitor (≥1 cycle, ≤180 days since last cycle).\n* Clinical diagnosis of irColitis (CTCAE \\>grade 2).\n* Age ≥18 years\n* Able to ingest capsules.\n* Consent to provide blood and stool samples.\n* Accessible for treatment and follow-up.\n* Agreement to use highly effective contraception if of childbearing potential.\n\nExclusion Criteria:\n\n* Prior\u002Fconcurrent malignancy that could interfere with safety\u002Fefficacy assessment.\n* Colostomy.\n* Prior diagnosis of malabsorption.\n* Untreated chronic hepatitis B or C.\n* Solid organ transplant recipients.\n* HIV-positive status.\n* Pregnancy or breastfeeding.",{"count":188,"type":21},21,[190],"PHASE1","The goal of this clinical trial is to evaluate the safety and tolerability of KAN-004 in patients with immune-related colitis.",[25,193],"Diarrhea Caused by Antitumor Drugs","2026-04-08",{"date":196,"type":32},"2026-04-13",{"date":198,"type":32},"2026-03-01",{"date":200,"type":21},"2030-12-31",{"name":202,"class":90},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":51,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":40},"100365466","phase-1-fecal-microbiota-transplantation-in-treating-immune-checkpoint-inhibitor-induced-diarrhea-or-colitis-in-genitourinary-cancer-patients-100365466","NCT04038619","Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients","Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea\u002FColitis in Genitourinary Cancer Patients","Inclusion Criteria:\n\n1. Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head \\& neck, sarcoma\u002Flymphoma, gastrointestinal system (luminal GI, hepatobiliary, pancreas), gynecology system (ovarian, uterine, cervical), and breast malignancies\n2. Treatment with any ICPI agent(s)\n3. Participants with new onset of ≥ grade 2 ICPI-induced diarrhea and\u002For colitis symptoms based on the Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 45 days prior to date of FMT treatment without involvement of non- GI toxicity\n4. Participants with a history of steroid use before FMT can be allowed if last dose was \\> 30 days prior to FMT treatment or treatment duration was for \\\u003C7 days beyond one week prior to FMT treatment\n5. Participants with a history of immunosuppressant (Infliximab, Vedolizumab etc) use before FMT can be allowed if last dose was administered ≥ 3 months prior to FMT treatment when used for the treatment of conditions other than for ICI- induced GI toxicities (e.g., Infliximab is used in the treatment of Crohn's disease, rheumatoid arthritis, plaque psoriasis, and Vedolizumab is used in treating ulcerative colitis)\n6. No concern for active concomitant GI infection at the time of initiation of protocol therapy as confirmed by stool tests or as per the treating physician based on clinical presentation\n7. Patient has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g., lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of protocol therapy and\u002F or imaging (e.g. CXR, CT CAP etc) confirms the absence of active infections (e.g. TB) within 60 days prior to initiation of protocol therapy\n8. Ability to understand and willingness to sign an informed consent form\n9. Life expectancy \\> 6 months\n\nExclusion Criteria\n\n1. Age younger than 18 years\n2. Participants with persistent GI infection confirmed with positive stool test(s) despite completing 5 days of antibiotics prior to initiation of protocol therapy\n3. History of inflammatory bowel disease, and\u002For radiation enteritis or colitis with active disease status at the time of study treatment initiation\n4. Pregnant and breastfeeding women\n5. Women who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \\> 1 year prior to consent and\u002F or clear documentation states that participant is peri- or post-menopausal or there has been recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment\n6. Immunosuppressive treatment at onset of ICPI-induced diarrhea\u002Fcolitis\n7. Any medical conditions (e.g. severe heart failure, brain hemorrhage, septic shock, etc.) that are high risk for colonoscopy procedure by the assessment of the study PI or Co-PIs.\n8. Participants who develop concurrent non-GI toxicity at the time of study treatment\n9. Donors at risk for monkeypox infection and\u002F or exposure as determined by a questionnaire",{"count":211,"type":21},40,[190],"This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea\u002Fcolitis.",[25,215,216,147,217,218,219,220,221],"Diarrhea","Malignant Genitourinary System Neoplasm","Lung Cancer","Ovarian Cancer","Uterine Cancer","Breast Cancer","Cervical Cancer","2026-03-17",{"date":224,"type":32},"2026-03-20",{"date":226,"type":32},"2021-02-01",{"date":228,"type":21},"2027-12-31",{"name":230,"class":90},"M.D. Anderson Cancer Center",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":51,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":40},"100348630","phase-1-role-of-gut-microbiome-and-fecal-transplant-on-medication-induced-gi-complications-in-patients-with-cancer-100348630","NCT03819296","Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer","Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population","Inclusion Criteria:\n\n1. Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer or genitourinary (GU) malignancies (Project 1).\n2. Diagnosis of any cancer type (Projects 2 and 3)\n3. Treatment with any ICPI agent\n4. Ability to understand and willingness to sign an informed consent form and rate surveys\n5. Life expectancy \\> 4 months (Project 3)\n6. ICPI-related diarrhea and\u002For colitis of any grade with or without concurrent non- GI toxicity as the toxicity group (project 1)\n7. Patients with no organ toxicity as the control group (project 1)\n8. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity (initial episode or recurrence) receiving standard treatment of immunosuppressive agents (steroid, infliximab, vedolizumab, or ustekinumab) any time during the colitis disease course until sustained resolution of GI toxicity, or one- year time point after enrollment (Project 2)\n9. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 as GI toxicity without involvement of non- GI toxicity within 45 days prior to FMT (Project 3)\n10. ICPI-related colitis and\u002For diarrhea of grade ≥ 2 within 45 days prior to FMT with ANY of the following characteristics (project 3):\n\n    (i) refractory to treatment of steroid and two doses of non-steroidal immunosuppressants e.g. infliximab, vedolizumab or ustekinumab,\n\n    (ii) contraindication for immunosuppressive treatment,\n\n    (iii) recurrence after successful initial treatment,\n\n    (iv) recurrent symptoms once steroid is tapered down\u002Foff or diarrhea\u002Fcolitis symptoms are steroid dependent, or\n\n    (v) patients with a history of refractory ICPI-related colitis and\u002For diarrhea to medical treatment, even if they have improved symptoms from supportive care within 45 days prior to FMT\n11. No concern for active concomitant GI infection for the ICPI diarrhea\u002Fcolitis work up at the time of protocol therapy initiation as confirmed by stool tests or as per the treating physician based on clinical presentation (project 3)\n12. Patient who has been cleared for enrollment by Infectious Diseases consultant or treating physician if positive infection workup or screening tests (e.g. lifelong positive T-spot due to BCG inoculation, chronic colonization) prior to initiation of diarrhea\u002Fcolitis treatment (project 3)\n\nExclusion Criteria:\n\n1. Age younger than 18 years\n2. History of inflammatory bowel disease, and\u002For radiation enteritis or colitis with active disease status at the time of study treatment initiation\n3. Pregnant and breastfeeding women\n4. Women of child-bearing potential who have positive urine or serum pregnancy test or refuse to do pregnancy test unless last menstrual cycle was \\> 1 year prior to consent and\u002F or clear documentation states that patient is peri- or post-menopausal or there was recent supporting objective evidence of 'no pregnancy' status (e.g. blood or imaging) within 30 days prior to date of study treatment\n5. Patients who develop concurrent non- GI toxicity at the time of FMT treatment (project 3)\n6. Patients with active bacterial or fungal infection (Project 3)\n7. Donors at risk for monkeypox infection and\u002F or exposure as determined by a questionnaire (Project 3)\n\nWithdrawal Criteria\n\n1. Patients may withdraw from the trial at any time\n2. Patients who develop GI perforation or toxic colitis that require surgery from ICPI colitis\n3. In project 3, if the first 30% of cases fail the fecal transplant treatment, then project 3 will be terminated",{"count":239,"type":21},800,[190],"This trial studies the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.",[243,244,245,246,247,248,249,250,251,252,25,253,216,254,255,256,257,258,259,260,261,262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284],"Clinical Stage 0 Cutaneous Melanoma AJCC v8","Clinical Stage I Cutaneous Melanoma AJCC v8","Clinical Stage IA Cutaneous Melanoma AJCC v8","Clinical Stage IB Cutaneous Melanoma AJCC v8","Clinical Stage II Cutaneous Melanoma AJCC v8","Clinical Stage IIA Cutaneous Melanoma AJCC v8","Clinical Stage IIB Cutaneous Melanoma AJCC v8","Clinical Stage IIC Cutaneous Melanoma AJCC v8","Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Lung Non-Small Cell Carcinoma","Malignant Solid Neoplasm","Pathologic Stage 0 Cutaneous Melanoma AJCC v8","Pathologic Stage I Cutaneous Melanoma AJCC v8","Pathologic Stage IA Cutaneous Melanoma AJCC v8","Pathologic Stage IB Cutaneous Melanoma AJCC v8","Pathologic Stage II Cutaneous Melanoma AJCC v8","Pathologic Stage IIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIC Cutaneous Melanoma AJCC v8","Pathologic Stage III Cutaneous Melanoma AJCC v8","Pathologic Stage IIIA Cutaneous Melanoma AJCC v8","Pathologic Stage IIIB Cutaneous Melanoma AJCC v8","Pathologic Stage IIIC Cutaneous Melanoma AJCC v8","Pathologic Stage IIID Cutaneous Melanoma AJCC v8","Pathologic Stage IV Cutaneous Melanoma AJCC v8","Stage 0 Lung Cancer AJCC v8","Stage I Lung Cancer AJCC v8","Stage IA1 Lung Cancer AJCC v8","Stage IA2 Lung Cancer AJCC v8","Stage IA3 Lung Cancer AJCC v8","Stage IB Lung Cancer AJCC v8","Stage II Lung Cancer AJCC v8","Stage IIA Lung Cancer AJCC v8","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8","2026-03-10",{"date":287,"type":32},"2026-03-11",{"date":289,"type":32},"2021-02-21",{"date":291,"type":21},"2026-10-31",{"name":230,"class":90},{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":51,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":313,"locationsCount":40},"100531969","fmt-in-checkpoint-inhibitor-mediated-diarrhea-and-colitis-100531969","NCT06206707","FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis","Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea\u002FColitis: a Randomised, Double-blind Pilot Efficacy and Safety Study","Immunobiome","Inclusion Criteria:\n\n1. Age 18 years or above.\n2. Histologically proven diagnosis of malignant melanoma and\u002For kidney cancer.\n3. Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.\n4. Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.\n5. Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.\n6. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosed bacterial infection requiring antibiotic treatment at inclusion.\n2. Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.\n3. Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.\n4. Unable to ingest capsules.\n5. Unable to understand written or oral patient information.",{"count":76,"type":21},[104],"The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea\u002Fcolitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.\n\nThe aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.\n\nParticipants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.\n\nResearchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.",[215,25,305,306],"Malignant Melanoma","Kidney Cancer","2025-11-14",{"date":309,"type":32},"2025-11-17",{"date":311,"type":32},"2024-01-23",{"date":291,"type":21},{"name":314,"class":90},"University of Aarhus",{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":100,"enrollmentInfo":322,"targetDuration":4,"studyType":51,"phases":324,"briefSummary":326,"conditions":327,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":40},"100596582","phase-2-evaluate-the-efficacy-and-safety-of-probiotic-6600-as-an-adjuvant-therapy-for-colitis-100596582","NCT07047339","Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis","A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Probiotic 6600 as an Adjuvant Therapy for Colitis","Inclusion Criteria:\n\n1. Ulcerative colitis (UC) : met the clinical diagnostic criteria of UC \"Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi 'an)\", and modified Mayo score ≥4 points;\n2. Crohn's disease (CD) : met the clinical diagnostic criteria of CD \"Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023, Guangzhou)\", and CDAI score ≥220;\n3. Colitis: clinical diagnosis of colitis and modified SCCAI score ≥3; 3.\n4. The age of signing the informed consent form was from 18 to 75 years old (including the cut-off value, male and female were not limited);\n5. Complete medical history;\n6. From the time of informed consent until 3 months after the last dose of dose, the participant committed to not having any plans to have children or to have any plans to donate sperm or eggs, and to voluntarily use non-pharmacologic contraception;\n7. Fully understand the content, process and possible adverse reactions of the trial, voluntarily participate in the trial, and sign the informed consent.\n\nExclusion Criteria:\n\n1. Taking prebiotics or probiotics in the past 2 weeks or allergic to intervention preparations;\n2. Short bowel syndrome, abdominal abscess, toxic megacolon, intestinal perforation, active fistula of digestive tract, severe intestinal stenosis with obstructive symptoms, suspected intestinal obstruction, total colectomy;\n3. Other autoimmune diseases, hematological diseases, tumors, acute infections, severe hepatic and renal insufficiency (ALT\\>2 times the upper limit of normal), severe diseases such as neutropenia, heart failure, organic heart disease, viral hepatitis B, liver cirrhosis, renal impairment (serum creatinine \\> 2mg\u002FdL or 177mmol\u002FL), AIDS And mental disorders;\n4. History of psychoactive substance abuse;\n5. A history of drug or other dependent substance abuse, or heavy alcohol consumption in the last 2 weeks (i.e. 28 standard units per week for men and 21 standard units per week for women (1 standard unit contains 14g of alcohol, such as 360mL of beer or 25mL of 40% spirits or 150mL of wine); Heavy drinkers during the trial;\n6. Pregnant or breastfeeding women, or planning to become pregnant in the next 6 months;\n7. Nervous system diseases such as Alzheimer's disease, stroke, Parkinson's disease;\n8. Participated in other clinical trials within the past 6 months;\n9. Incomplete medical record information (including gender, age, diagnostic information, colonoscopy results, pathological diagnosis results and other demographic data, etc.);\n10. Other investigators deemed ineligible for enrollment.",{"count":323,"type":21},120,[53,325],"PHASE3","This study was conducted in two phases. In Phase I, 40 UC participants, 40 CD participants, and 40 colitis participants were randomly assigned in a 1:1 ratio to the experimental group and the control group, respectively. The study included a screening period (1 week), a double-blind treatment period (24 weeks), an exit examination (1 day), and a safety follow-up period (4 weeks). After providing informed consent, participants who met the inclusion criteria and those who did not meet the exclusion criteria were randomly assigned, in a 1:1 ratio, to receive either the trial (probiotic 6600 capsules) or the control group (placebo). The clinical remission rate (SCCAI score ≤2 and no single subscore \\>1) after 24 weeks of treatment was calculated. Mayo score ≤2 and no single subscore \\>1; CDAI score ≤2 and no single subscore \\>1) were used as the primary efficacy index.",[25,328,329],"IBD (Inflammatory Bowel Disease)","Probiotic Intervention","2025-06-24",{"date":332,"type":32},"2025-07-02",{"date":334,"type":21},"2025-07-01",{"date":336,"type":21},"2026-12-31",{"name":338,"class":90},"Changhai Hospital",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":344,"acronym":345,"eligibilityCriteria":346,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":51,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100512070","phase-3-efficacy-and-safety-of-infliximab-for-immune-checkpoint-inhibitor-induced-colitis-100512070","NCT05947669","Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis","Efficacy and Safety of Infliximab for Immune Checkpoint Inhibitor Induced Colitis: a Multinational, Randomised, Open Label, Phase III Trial - The iCaD Study","iCaD","Inclusion Criteria\n\n* Untreated mCTCAE grade 2-4 diarrhoea or colitis, or persistent mCTCAE grade 2 diarrhoea after administration of loperamide or equivalent for mCTCAE grade ≤ 2 diarrhoea\n* No signs of colonic perforation or infection\n* Age ≥ 18\n* Understands the nature and purpose of the study and the study procedures and has signed informed consent\n* Is able to read, understand, and complete questionnaires and daily components of the patient Diary for the study period\n* Histologically confirmed malignant solid tumours\n* Treatment with immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1 or anti-PD-L1) within the past 12 weeks. Immune checkpoint inhibitors can be administered as single agents or as combination therapy with anti-CTLA-4 and anti-PD-1\n* No probability of a concomitant treatment (e.g. laxatives) other than the immune checkpoint inhibitor being the causal drug for the colitis or diarrhoea\n* Prior treatment with immune checkpoint inhibitors is allowed\n* Usage of prednisolone ≤ 10 mg daily for non irAE is allowed\n* Diagnostic work up including screening for viral hepatic infection and QuantiFERON-TB for mycobacterium tuberculosis must be requisitioned but will not need to be reported prior to study enrolment\n* Women of child bearing potential must have a negative serum (preferred) or urine pregnancy test within 72 hours prior to registration.\n\n  * Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e. females who have had evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression or other reasons.\n* Patients of childbearing \u002F reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and after the study treatment:\n\n  * for at least 6 months after the last study treatment, or depending on the duration antineoplastic treatment\n  * Note: A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. Such methods include:\n\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)\n    * Intrauterine device (IUD)\n    * Intrauterine hormone-releasing system (IUS)\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Sexual abstinence\n\nExclusion Criteria\n\n* Prior history of inflammatory bowel disease, colitis, or diarrhoea requiring treatment with any corticosteroid, or any other immunosuppressant medication\n* Prior history of recurrent bowel disease including symptomatic diverticulosis\n* Current positive testing for Clostridium difficile or other colonic infection\n* Current bacterial infection requiring antibiotic treatment, or systemic fungal infection\n* Ongoing antibiotic treatment for any reason\n* Treatment with systemic corticosteroids within the last four weeks prior to study enrolment (daily usage of prednisolone ≤ 10 mg for non irAE conditions is accepted)\n* Concurrent immune-related adverse events requiring immunosuppressant medication of any kind\n* Known hypersensitivity or contraindications to systemic corticosteroids or infliximab\n* Prior history of viral hepatitis with a positive viral load, known untreated mycobacterium tuberculosis, or known active herpes zoster infection",{"count":348,"type":21},195,[325],"The goal of this clinical trial is to assess whether the early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids for severe ir-colitis\u002Fdiarrhoea will reduce the time to grade ≤ 1 ir-colitis\u002Fdiarrhoea compared to corticosteroids alone in patients scheduled for ICI treatment for solid tumors and untreated mCTCAE grade 2-4 diarrhoea or colitis.\n\nThe main question it aims to answer is:\n\n• Can an early introduction of biological treatment with a TNF-alpha inhibitor (infliximab) in addition to corticosteroids reduce the time to grade ≤ 1 ir-colitis\u002Fdiarrhoea compared to corticosteroids alone.\n\nParticipants will be randomised 1:1:\n\nArm A: All patients will receive same dose of methylprednisolone i.v. daily. Arm B: Patients allocated to Arm B will in addition receive infliximab i.v. day 1 or 2.\n\nStudy patients are evaluated with blood samples, faecal samples and by sigmoidoscopy. Procedures are performed before randomisation and as part of follow up.",[25],"2023-08-22",{"date":354,"type":32},"2023-08-24",{"date":352,"type":32},{"date":357,"type":21},"2028-09",{"name":359,"class":90},"Odense University Hospital",3]