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SK-005",{"type":80,"coordinates":1305},[1297,1298],{"lat":1298,"lon":1297},[1308],{"name":87,"role":88,"phone":89,"phoneExt":31,"email":90},{"facility":1310,"status":93,"city":1311,"state":31,"zip":1312,"country":1271,"countryCode":1272,"cosmosGeoPoint":1313,"geoPoint":1317,"contacts":1318},"Site SK-006","Zvolen","960 01",{"type":80,"coordinates":1314},[1315,1316],19.15324,48.57442,{"lat":1316,"lon":1315},[1319],{"name":87,"role":88,"phone":89,"phoneExt":31,"email":90},{"type":1321,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","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","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":1333,"type":1334},204,"ESTIMATED","INTERVENTIONAL",[1337],"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.",[1340,1341,1342],"Ulcerative Colitis (UC)","Severe Ulcerative Colitis","Moderate Ulcerative Colitis",[1344,1345,1346,1347],"Colitis","Ulcerative Colitis","Inflammatory Bowel Disease","IBD","2026-09-22",{"date":1350,"type":1351},"2026-09-29","ACTUAL",{"date":1353,"type":1351},"2026-08-28",{"date":1355,"type":1334},"2028-06",{"name":5,"class":6},115]