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)
LISCure Biosciences
Summary
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
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 recei…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 t…
Interventions
- DrugLB-P8 low-dose
One capsule QD (1×10\^10 CFU/day) oral administration
- DrugLB-P8 high-dose
One capsule QD (1×10\^11 CFU/day) oral administration
- DrugPlacebo
One capsule QD oral administration
Locations (7)
- University of California DavisSacramento, California
- UCHealth University of Colorado HospitalAurora, Colorado
- University Of Iowa Hospitals And ClinicsIowa City, Iowa
- Mercy Medical CenterBaltimore, Maryland
- Mayo ClinicRochester, Minnesota
- The Vanderbilt ClinicNashville, Tennessee