[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"moderate-ulcerative-colitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:moderate-ulcerative-colitis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100657995","phase-2-a-trial-to-investigate-pali-2108-versus-placebo-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100657995",false,"NCT07845487","A Trial to Investigate PALI-2108 Versus Placebo in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Induction and Maintenance Therapy With PALI-2108 in Participants With Moderately to Severely Active Ulcerative Colitis","ASCENTRA-UC","Key Inclusion Criteria:\n\n* Documented clinical diagnosis of UC for ≥ 3 months prior to Screening. The diagnosis of UC must be confirmed by endoscopic and histologic evidence.\n\n  * If a histopathology report is not available in the source records, a biopsy for a local histopathology evaluation (to obtain a report) can be obtained during the screening endoscopy procedure.\n* Moderately to severely active UC, defined as:\n\n  * mMS of 5 to 9 (inclusive), AND\n  * ES ≥ 2, AND\n  * RB ≥ 1.\n* Participants must satisfy at least one of the criteria listed under item a OR at least one of the criteria listed under item b:\n\n  a. History of inadequate response or loss of response, or intolerance to at least one prior UC therapy, defined as: i. Oral prednisone ≥ 40 mg\u002Fday (or equivalent) or budesonide ≥ 9 mg\u002Fday for ≥ 2 weeks.\n\nii. Corticosteroid dependence: unable to taper \\\u003C 10 mg\u002Fday prednisone equivalent within 3 months, or relapse within 3 months of discontinuation.\n\niii. Immunosuppressants: azathioprine ≥ 2 mg\u002Fkg\u002Fday, 6-mercaptopurine (6-MP) ≥ 1.0 mg\u002Fkg\u002Fday (or therapeutic 6-thioguanine nucleotide \\[6-TGN\\] level) for ≥ 12 weeks, or methotrexate ≥ 15 mg\u002Fweek subcutaneous or intramuscular.\n\niv. Approved advanced therapies at the approved labelled dose:\n\n1. Anti-tumor necrosis factor (TNF), anti-integrin (vedolizumab), or anti-IL-12\u002F23 for at least 8 weeks; anti-IL 23 for at least 12 weeks.\n2. Janus kinase (JAK) inhibitor for at least 8 weeks; sphingosine-1-phosphate receptor (S1PR) modulator for at least 12 weeks.\n\nNote: Demonstration of intolerance requires no minimum dose nor duration of use.\n\nb. Currently receiving one or more of the following treatments: i. Stable oral prednisone at ≤ 20 mg\u002Fday (or equivalent) or budesonide ≤ 9 mg for ≥ 2 weeks prior to randomization.\n\nii. Stable dose of thiopurine (azathioprine or 6-MP) for ≥ 4 weeks prior to randomization, and have started the treatment ≥ 12 weeks prior to randomization.\n\niii. Stable dose of oral aminosalicylates for ≥ 2 weeks prior to randomization.\n\nKey Exclusion Criteria:• Diagnosis of Crohn's disease or IBD-Unclassified (IBD-U; indeterminate colitis) or a history of ischemic colitis or radiation colitis.\n\n* UC limited to rectum (\\\u003C 15 cm from anal verge).\n* Any prior history of suicidal behavior (actual, interrupted, aborted attempt, or preparatory acts).\n* Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation type 4 or 5, or any active suicidal ideation with some intent to act.\n* Severe depression at Screening based on a validated scale threshold (e.g., Patient Health Questionnaire-9 \\[PHQ-9\\] ≥ 20, or PHQ-9 item 9 \\> 0) at Screening.\n* Failure or intolerance of \\> 3 classes of approved advanced therapies or \\> 4 approved individual advanced therapies.","ALL","18 Years","75 Years",{"count":21,"type":22},204,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The ASCENTRA-UC study is a phase 2 study testing PALI-2108 in patients with moderate to severe ulcerative colitis. Doses of drug will be compared against a placebo to see how well it works, how safe it is, and how the body responds to it.",[28,29,30],"Ulcerative Colitis (UC)","Severe Ulcerative Colitis","Moderate Ulcerative Colitis",[32,33,34,35],"Colitis","Ulcerative Colitis","Inflammatory Bowel Disease","IBD","RECRUITING","2026-09-22",{"date":39,"type":40},"2026-09-29","ACTUAL",{"date":42,"type":40},"2026-08-28",{"date":44,"type":22},"2028-06",{"name":46,"class":47},"Palisade Bio","INDUSTRY",115]