A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC

NCT06699121 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: LB08-211
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Primary Sclerosing Cholangitis (PSC)

Keywords

PSC; Pruritus; Inflammatory bowel disease; IBD; Itch; Cholestasis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (13)

• 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™)

  (Part 2) Up to 24 weeks of treatment from the Baseline

• Changes from baseline in biliary metrics (biliary strictures and dilatations)

  (Part 2) Up to 24 weeks of treatment from the Baseline

• Changes from baseline in liver stiffness

  (Part 2) Up to 24 weeks of treatment from the Baseline

Study Arms (3)

LB-P8 low-dose

EXPERIMENTAL

Oral capsule, 1×10\^10 CFU/day

Drug: LB-P8 low-dose

LB-P8 high-dose

EXPERIMENTAL

Oral capsule, 1×10\^11 CFU/day

Drug: LB-P8 high-dose

Placebo

PLACEBO COMPARATOR

Oral capsule, placebo

Drug: Placebo

Interventions

LB-P8 low-dose DRUG

One capsule QD (1×10\^10 CFU/day) oral administration

LB-P8 low-dose

LB-P8 high-dose DRUG

One capsule QD (1×10\^11 CFU/day) oral administration

LB-P8 high-dose

Placebo DRUG

One capsule QD oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• LISCure Biosciences: lead

Study Sites (7)

University of California Davis

Sacramento, California, 95817, United States

NOT YET RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Mercy Medical Center

Baltimore, Maryland, 21202, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

NOT YET RECRUITING

The Vanderbilt Clinic

Nashville, Tennessee, 37232, United States

RECRUITING

Liver institute Northwest

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Cholangitis, Sclerosing; Pruritus; Inflammatory Bowel Diseases; Cholestasis

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Intestinal Diseases

Central Study Contacts

LISCure Biosciences Clinical Trials

CONTACT

+82317061710; clinical@liscure.bio

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2024
• First Posted: November 21, 2024
• Study Start: November 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)