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MD",{"type":157,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100569813","phase-2-a-study-to-assess-the-safety-and-efficacy-of-lb-p8-in-patients-with-psc-100569813",false,"NCT06699121","A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC","A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating the Safety and Efficacy of LB P8 in Patients With Primary Sclerosing Cholangitis (PSC)","Inclusion Criteria:\n\n* Age: 18 to 75 years\n* A diagnosis of PSC based on cholangiographic evidence of PSC in accordance with American Association for the Study of Liver Diseases (AASLD) guidelines\n* ALP \\>1.5 times the ULN at screening\n* PSC with or without IBD, such as ulcerative colitis or Crohn's disease\n* If patients are being administered biologic or advanced therapeutic treatments, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins, they must be on a stable dose for ≥3 months prior to, and including, Day 0 and plan to remain on a stable dose throughout the study\n* If patients are receiving ursodeoxycholic acid, they must be on a stable dose (not exceeding 23 mg\u002Fkg\u002Fday) for \\>3 months prior to screening\n* Patient agrees to stop all probiotics for at least 2weeks prior to treatment\n* Patient is unable to conceive and\u002For patient who's partner is unable to become pregnant and\u002For agree to use effective methods of contraception when engaging in heterosexual intercourse\n\nExclusion Criteria:\n\n* Treatment with any investigational agents within 3 months or 5 half-lives, whichever is longer prior to treatment or during the study. Gene therapy or other long-lasting investigational agents with unknown half-life is not allowed\n* History of a liver transplant or anticipated need for a liver transplant within 1 year\n* Patients who show evidence of significant worsening of hepatic function will be excluded.\n* Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters\n* Model for end-stage liver disease (MELD) score as below, unless the MELD is driven by anticoagulant therapy, vitamin deficiency, or kidney disease:\n* MELD Score of \\>12 (decompensated cirrhosis) for Part 1 of the study\n* MELD Score of \\>12 for Part 2 of the study\n* Small-duct PSC (in the absence of large duct PSC)\n* Secondary causes of sclerosing cholangitis including IgG4 associated sclerosing cholangitis\n* Any history of cholangiocarcinoma, gallbladder cancer, or hepatocellular carcinoma\n* History of any malignancy with lymph node or regional metastases within 5 years or current malignancy undergoing active treatment\n* Patients who require chronic use of antibiotics, received antibiotics in the last 1 month, or received Rebyota or Vowst (applicable for patients with Clostridioides difficile infection)\n* In patients with ulcerative colitis, partial Mayo score of \\>6 or, patients with Crohn's disease if CDAI of \\>220\n* Chronic kidney injury\n* Recent acute cholangitis (within 90 days)\n* Patients with indwelling biliary drain (or stent), total proctocolectomy with ileal anal pouch, partial large bowel resections or history of small bowel resection\n* Other causes of liver disease, such as autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), AIH\u002FPSC overlap syndrome, alpha-1-antitrypsin deficiency, viral hepatitis, iron overload syndrome, Wilson disease, nonalcoholic steatohepatitis, and\u002For alcohol related liver disease. Additionally, positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) (detectable HCV RNA in the serum), or human immunodeficiency virus antibodies (anti HIV)\n* Active drug (known or suspected use of illicit drugs or drugs of abuse) or alcohol abuse disorder\n* Female patients who are pregnant, nursing, or planning to become pregnant during the study\n* Clinically significant and\u002For active infection\n* Subjects with a greater degree of immunosuppression, as evidenced by Alsolute neutrophil count \\\u003C500 cells\u002FmL or in the investigator's judgement immunosuppressed and at higher risk of infection","ALL","18 Years","75 Years",{"count":169,"type":170},87,"ESTIMATED","INTERVENTIONAL",[173],"PHASE2","The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.",[176],"Primary Sclerosing Cholangitis (PSC)",[178,179,180,181,182,183],"PSC","Pruritus","Inflammatory bowel disease","IBD","Itch","Cholestasis","2025-10-22",{"date":186,"type":187},"2025-10-24","ACTUAL",{"date":189,"type":170},"2025-11",{"date":191,"type":170},"2029-02",{"name":5,"class":6},7]