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)

The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.

Study Overview

• Status: Recruiting
• Conditions: Primary Sclerosing Cholangitis (PSC)
• Intervention / Treatment: Drug: LB-P8 low-dose; Drug: LB-P8 high-dose; Drug: Placebo

Detailed Description

This is phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of LB-P8 in adult patients with primary sclerosing cholangitis(PSC).

• Part 1 will evaluate safety and tolerability of 2 pre-selected dose level of LB-P8 (low-dose[1×10^10 CFU/capsule] and high dose [1×10^11 CFU/capsule]) in adult patients with PSC. Part 1 plans to enroll a maximum number of 12 patients based on a "3+3" study design.
• Part 2 will evaluate safety and efficacy in adult patients with PSC. Eligible patients with PSC will be randomized in a 1:1:1 ratio to receive treatment with low-dose LB-P8(1×10^10 CFU/capsule), high-dose LB-P8(1×10^11 CFU/capsule) or matched placebo capsule. Part 2 plans to enroll and randomize 75 patients to obtain 60 evaluable patients.

• Study Type: Interventional
• Enrollment (Estimated): 87
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: LISCure Biosciences Clinical Trials; Phone Number: +82317061710; Email: clinical@liscure.bio

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Not yet recruiting
      • University of California Davis
      • Principal Investigator: Christopher Bowlus, MD
      • Contact: University of California Davis; Phone Number: 800-282-3284
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • UCHealth University of Colorado Hospital
      • Principal Investigator: Lisa Forman, MD
      • Contact: UCHealth University of Colorado Hospital; Phone Number: 7208480000
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: University Of Iowa Hospitals And Clinics; Phone Number: 319-356-1616
      • Principal Investigator: Alan Gunderson, MD
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Recruiting
      • Mercy Medical Center
      • Principal Investigator: Paul Thuluvath, MD
      • Contact: Mercy Medical Center; Phone Number: 410-332-9000
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Not yet recruiting
      • Mayo Clinic
      • Contact: Mayo Clinic; Phone Number: 507-284-2511
      • Principal Investigator: John Eton, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Recruiting
      • The Vanderbilt Clinic
      • Principal Investigator: Manhal Izzy, MD
      • Contact: The Vanderbilt Clinic; Phone Number: 615-322-5000
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Liver Institute Northwest
      • Principal Investigator: Kris Kowdley, MD
      • Contact: Liver institute Northwest; Phone Number: 206-536-3030; Email: info@liverinstitutenw.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18 to 75 years
• A diagnosis of PSC based on cholangiographic evidence of PSC in accordance with American Association for the Study of Liver Diseases (AASLD) guidelines
• ALP >1.5 times the ULN at screening
• PSC with or without IBD, such as ulcerative colitis or Crohn's disease
• 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
• If patients are receiving ursodeoxycholic acid, they must be on a stable dose (not exceeding 23 mg/kg/day) for >3 months prior to screening
• Patient agrees to stop all probiotics for at least 2weeks prior to treatment
• Patient is unable to conceive and/or patient who's partner is unable to become pregnant and/or agree to use effective methods of contraception when engaging in heterosexual intercourse

Exclusion Criteria:

• 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
• History of a liver transplant or anticipated need for a liver transplant within 1 year
• Patients who show evidence of significant worsening of hepatic function will be excluded.
• Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters
• Model for end-stage liver disease (MELD) score as below, unless the MELD is driven by anticoagulant therapy, vitamin deficiency, or kidney disease:
• MELD Score of >12 (decompensated cirrhosis) for Part 1 of the study
• MELD Score of >12 for Part 2 of the study
• Small-duct PSC (in the absence of large duct PSC)
• Secondary causes of sclerosing cholangitis including IgG4 associated sclerosing cholangitis
• Any history of cholangiocarcinoma, gallbladder cancer, or hepatocellular carcinoma
• History of any malignancy with lymph node or regional metastases within 5 years or current malignancy undergoing active treatment
• 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)
• In patients with ulcerative colitis, partial Mayo score of >6 or, patients with Crohn's disease if CDAI of >220
• Chronic kidney injury
• Recent acute cholangitis (within 90 days)
• Patients with indwelling biliary drain (or stent), total proctocolectomy with ileal anal pouch, partial large bowel resections or history of small bowel resection
• Other causes of liver disease, such as autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), AIH/PSC overlap syndrome, alpha-1-antitrypsin deficiency, viral hepatitis, iron overload syndrome, Wilson disease, nonalcoholic steatohepatitis, and/or 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)
• Active drug (known or suspected use of illicit drugs or drugs of abuse) or alcohol abuse disorder
• Female patients who are pregnant, nursing, or planning to become pregnant during the study
• Clinically significant and/or active infection
• Subjects with a greater degree of immunosuppression, as evidenced by Alsolute neutrophil count <500 cells/mL or in the investigator's judgement immunosuppressed and at higher risk of infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LB-P8 low-dose; Oral capsule, 1×10^10 CFU/day	Drug: LB-P8 low-dose; One capsule QD (1×10^10 CFU/day) oral administration
Experimental: LB-P8 high-dose; Oral capsule, 1×10^11 CFU/day	Drug: LB-P8 high-dose; One capsule QD (1×10^11 CFU/day) oral administration
Placebo Comparator: Placebo; Oral capsule, placebo	Drug: Placebo; One capsule QD oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of 2 different doses of LB-P8	Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0	(Part 1) Up to 4 weeks of treatment from the Baseline
Safety and tolerability of LB-P8	Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0	(Part 2) Up to 24 weeks of treatment from the Baseline
Mean percent change from baseline in Serum Concentrations of Alkaline Phosphatase (ALP)		(Part 2) Up to 24 weeks of treatment from the Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in ALP		(Part 2) Up to 24 weeks of treatment from the Baseline
Percentage of patients who achieve ALP of <1.5 × upper limit of normal (ULN)		(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in enhanced liver fibrosis (ELF™)	Hyaluronic acid, procollagen-3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1 will be assessed in blood for ELF test.	(Part 2) Up to 24 weeks of treatment from the Baseline
Changes from baseline in biliary metrics (biliary strictures and dilatations)	Biliary metrics (biliary strictures and dilatations) will be assessed by magnetic resonance cholangiopancreatography (MRCP)	(Part 2) Up to 24 weeks of treatment from the Baseline
Changes from baseline in liver stiffness	Liver stiffness will be measured by transient elastography (FibroScan®)	(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in alanine aminotransferase (ALT)		(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in aspartate aminotransferase (AST)		(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in gamma glutamyl transferase (GGT)		(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in prothrombin time (PT) and partial prothrombin time (PTT)		(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in international normalized ratio (INR)		(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in total and direct bilirubin		(Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in fasting serum bile acid level		(Part 2) Up to 24 weeks of treatment from the Baseline
The percentage of patients who experience liver disease progression	The percentage of patients who experience progression to cirrhosis, clinical decompensation rates, liver transplant, newly diagnosed cholangiocarcinoma, MELD score increase from <12 to >15 and Death from any cause	(Part 2) Up to 24 weeks of treatment from the Baseline

Collaborators and Investigators

• Sponsor: LISCure Biosciences

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: November 17, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 22, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Itch; IBD; Inflammatory bowel disease; Pruritus; PSC; Cholestasis
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Skin Manifestations; Biliary Tract Diseases; Skin Diseases; Gastroenteritis; Bile Duct Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Cholangitis; Cholangitis, Sclerosing; Inflammatory Bowel Diseases; Cholestasis; Pruritus
• Other Study ID Numbers: LB08-211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No