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RECRUITING
NCT06699121
PHASE2

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

Sponsor: LISCure Biosciences

View on ClinicalTrials.gov

Summary

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

87

Start Date

2025-11

Completion Date

2029-02

Last Updated

2025-10-24

Healthy Volunteers

No

Interventions

DRUG

LB-P8 low-dose

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

DRUG

LB-P8 high-dose

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

DRUG

Placebo

One capsule QD oral administration

Locations (7)

University of California Davis

Sacramento, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States

Mercy Medical Center

Baltimore, Maryland, United States

Mayo Clinic

Rochester, Minnesota, United States

The Vanderbilt Clinic

Nashville, Tennessee, United States

Liver institute Northwest

Seattle, Washington, United States