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

Part of paid clinical trials in Sacramento, California.

Sponsor
LISCure Biosciences
Study ID
NCT06699121
Phase
PHASE2
Status
Recruiting

Conditions

  • Primary Sclerosing Cholangitis (PSC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LB-P8 low-dose — DRUG
    One capsule QD (1×10\^10 CFU/day) oral administration
  • LB-P8 high-dose — DRUG
    One capsule QD (1×10\^11 CFU/day) oral administration
  • Placebo — DRUG
    One capsule QD oral administration

Study Details

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

Key Dates

Start date
Nov 30, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2028
Completion
Feb 28, 2029

Study Design

Enrollment
87 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LB-P8 low-dose
    Oral capsule, 1×10\^10 CFU/day
  • Experimental: LB-P8 high-dose
    Oral capsule, 1×10\^11 CFU/day
  • Placebo Comparator: Placebo
    Oral capsule, placebo

Primary Outcome Measure

Safety and tolerability of 2 different doses of LB-P8 [ Time Frame: (Part 1) Up to 4 weeks of treatment from the Baseline ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California DavisSacramentoCalifornia95817
University of California Davis
800-282-3284
Christopher Bowlus, MD (PRINCIPAL_INVESTIGATOR)
UCHealth University of Colorado HospitalAuroraColorado80045
UCHealth University of Colorado Hospital
7208480000
Lisa Forman, MD (PRINCIPAL_INVESTIGATOR)
University Of Iowa Hospitals And ClinicsIowa CityIowa52242
University Of Iowa Hospitals And Clinics
319-356-1616
Alan Gunderson, MD (PRINCIPAL_INVESTIGATOR)
Mercy Medical CenterBaltimoreMaryland21202
Mercy Medical Center
410-332-9000
Paul Thuluvath, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Mayo Clinic
507-284-2511
John Eton, MD (PRINCIPAL_INVESTIGATOR)
The Vanderbilt ClinicNashvilleTennessee37232
The Vanderbilt Clinic
615-322-5000
Manhal Izzy, MD (PRINCIPAL_INVESTIGATOR)
Liver institute NorthwestSeattleWashington98105
Liver institute Northwest
206-536-3030
Kris Kowdley, MD (PRINCIPAL_INVESTIGATOR)

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