Phase 2 Study of LB-P8 Oral Capsules to Evaluate Safety and Effectiveness in Adults With Primary Sclerosing Cholangitis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of LB-P8 in adults with primary sclerosing cholangitis PSC, a liver condition. This phase 2, randomized, double-blind, placebo-controlled study involves multiple centers and aims to better understand how LB-P8 works in patients with PSC. The study is sponsored by LISCure Biosciences and includes patients aged 18 to 75 years with specific liver-related criteria. The study has two parts Part 1 focuses on testing the safety and tolerability of two doses of LB-P8 a low dose of 1x1010 CFU per capsule and a high dose of 1x1011 CFU per capsule in up to 12 patients. Part 2 compares these two doses of LB-P8 to a placebo in 75 patients randomized equally among the three groups, with treatment lasting up to 24 weeks. Participants will take one oral capsule daily according to their assigned dose or placebo. During the study, participants will undergo various assessments including blood tests to measure liver enzyme levels, liver fibrosis, and other liver function indicators. Researchers will monitor safety, liver disease progression, and the impact of treatment on these measures. The study includes regular visits and evaluations throughout the treatment period, with the goal of understanding both safety and potential changes in liver health over time.

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