[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis-chronic":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100427330","phase-3-a-master-protocol-amaz-a-study-of-mirikizumab-ly3074828-in-pediatric-participants-with-ulcerative-colitis-or-crohns-disease-shine-on-100427330",false,"NCT04844606","A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)","A Master Protocol for a Phase 3, Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Efficacy and Safety of Mirikizumab in Children and Adolescents With Moderate-to-severe Ulcerative Colitis or Crohn's Disease","SHINE-ON","Inclusion Criteria:\n\n* Participants from originating studies (I6T-MC-AMBA \\[NCT05784246\\], I6T-MC-AMBU \\[NCT04004611\\], I6T-MC-AMAM \\[NCT03926130\\]) , I6T-MC-AMAY \\[NCT05509777\\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab\n* Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment.\n* Female participants must agree to contraception requirements.\n\nExclusion Criteria:\n\n* Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant.\n* Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ.\n* Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety.\n* Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation.\n* Participants must not have adenomatous polyps that have not been removed.\n* Participants must not be pregnant or breastfeeding.","ALL","2 Years","19 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.",[28,29,30,31],"Ulcerative Colitis","Ulcerative Colitis Chronic","Inflammatory Bowel Diseases","Crohn's Disease",[33,34,35,36],"Pediatric Ulcerative Colitis","Pediatric Crohn's Disease","Pediatric UC","Pediatric CD","RECRUITING","2026-06-19",{"date":40,"type":41},"2026-06-23","ACTUAL",{"date":43,"type":41},"2021-05-26",{"date":45,"type":22},"2030-12",{"name":47,"class":48},"Eli Lilly and Company","INDUSTRY",68,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":78},"100490502","phase-1-r-3750-in-patients-with-mild-to-moderate-ulcerative-colitis-100490502","NCT05666960","R-3750 in Patients With Mild to Moderate Ulcerative Colitis","A Single and Repeat Dosing Study of the Safety, Drug Exposure, and Clinical Activity of R-3750 in Patients With Mild to Moderate Ulcerative Colitis","INCLUSION CRITERIA:\n\n* 18-65 years of age\n* Ability to provide written informed consent\n* Confirmed diagnosed with UC by colonoscopy and histology and suffering from mild to moderate UC as defined by MMDAI with score of 3-9\n* On a stable dose of aminosalicylate (i.e. no change in medication within 4 weeks of study enrollment) and not planning to initiate new medication other than the study drug\n* For women of childbearing potential or men with a partner of childbearing potential, agree to use birth control methods (including hormonal contraceptives, intrauterine device (IUD) or hormone releasing system (IUS), vasectomy) and men will refrain from donating sperm during the study and at least 30 days after dosing (per FDA guidelines)\n* For the expansion cohort, a flexible sigmoidoscopy is required, unless an endoscopy was completed within 3 months from enrollment is available\n* Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio)\n\nEXCLUSION CRITERIA:\n\n* Pregnancy, planned pregnancy, breastfeeding women\n* Evidence of severe UC disease (MMDAI score greater than or equal to 10)\n* Evidence of any active or recent infection including chronic infectious disease such as Hepatitis B, C, or HIV\n* Evidence of any active or recent chronic chest infection with bronchiectasis or sinusitis, or covid-19 infection in the past 3 months\n* Treatment with immunosuppressants or anti-cancer drugs, e.g., anti-TNF-α agents, anti-integrin agents, azathioprine or 6-MP, 6-thioguanine, methotrexate, ozanimod, tofacitinid, upadacitinib, tacrolimus, cyclophosphamide, or cyclosporine or any other therapy that is not an aminosalicylate within the last 3 months\n* Received an investigational drug within 3 months (or 5 half-lives, whichever is longer) before study entry\n* Use of steroidal drugs to treat UC (e.g., prednisone \\>20 mg\u002Fday)\n* Use of probiotics within the last one (1) week and during the trial.\n* Treatment with systemic broad-spectrum antibiotics in the past 2 months\n* Major active systemic autoimmune disease other than UC\n* History of anaphylaxis or allergies to probiotics\n* History of alcohol or drug abuse within the past 2 years\n* History of stroke, or any cerebrovascular disease requiring medication\u002Ftreatment\n* History of cancer, apart from successfully treated basal cell carcinoma or in situ carcinoma of the cervix \\>1 year prior to enrollment\n* Significant laboratory abnormalities, including liver transaminases (AST or ALT) \\> 1.5X the upper limit of normal.\n* Second degree or higher heart block or clinically significant arrythmia\n* Any other clinically significant renal, hepatic, hematological or other disease or laboratory abnormality which, in the opinion of the investigator, would interfere with the conduct, the interpretation of the safety signals or results of the trial, or would place the subject at unacceptable risk\n* Any condition or circumstance that, in the opinion of the Principal Investigator, would compromise the safety of the subject or the quality of study data","18 Years","65 Years",{"count":60,"type":22},36,[62],"PHASE1","The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-3750) in patients with mild to moderate ulcerative colitis.\n\nPatients will take an oral dosage of probiotic (R-3750) and provide patient-reported and physician scored measures of their colitis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-3750) on fecal levels will also be measured.",[65,66,29,28],"Ulcerative Colitis Chronic Mild","Ulcerative Colitis Chronic Moderate",[68],"Colitis","2026-06-10",{"date":71,"type":41},"2026-06-12",{"date":73,"type":41},"2023-02-27",{"date":75,"type":22},"2026-10",{"name":77,"class":48},"Rise Therapeutics LLC",5,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},"100562113","phase-2-a-study-of-eltrekibart-and-mirikizumab-in-adult-patients-with-moderately-to-severely-active-ulcerative-colitis-100562113","NCT06598943","A Study of Eltrekibart and Mirikizumab in Adult Patients With Moderately to Severely Active Ulcerative Colitis","An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis","Inclusion Criteria:\n\n* Have had an established diagnosis of UC of ≥3 months in duration before baseline.\n* Have moderately to severely active UC as assessed by the UC disease activity score.\n* Have an inadequate response to, loss of response to, or intolerance to at least one conventional medication (including corticosteroids) or one advanced therapy (including biologics, Janus Kinase (JAK) inhibitors, or sphingosine-1-phosphate (S1P) immunomodulators).\n* Are on a stable dose of certain oral UC medications (including corticosteroids).\n* Must meet contraception requirements.\n\nExclusion Criteria:\n\n* Have received anti-interleukin (IL)-23p19 or anti-IL-12p40 antibodies in the past.\n* Have experienced a thrombotic event within 24 weeks before baseline.\n* Have a current diagnosis of Crohn's Disease or certain other inflammatory gastrointestinal diseases.\n* Have had certain abdominal surgeries within the past 3 months or are likely to require surgery for UC during the study.\n* Have a history of certain adenomas, dysplasia's, or malignancies.","75 Years",{"count":88,"type":22},140,[90],"PHASE2","The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).",[28,29],[94,95,96,30,97,98,99,68,100,101,102,103,104,105],"CXCR1\u002F2 Ligand receptor antagonist","IL-23 p19 antibody","Gastrointestinal Diseases","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Colitis, Ulcerative","Anti-Inflammatory Agents","Mirikizumab","Eltrekibart","Adult","Moderate to Severe","2026-04-17",{"date":108,"type":41},"2026-04-20",{"date":110,"type":41},"2024-10-10",{"date":112,"type":22},"2028-09",{"name":47,"class":48},207]