NCT06699121

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (estimated)
• Sponsor: LISCure Biosciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 receive treatment with low-dose LB-P8(1×10\^10 CFU/capsule), high-dose LB-P8(1×10\^11 CFU/capsule) or matched placebo capsule. Part 2 plans to enroll and randomize 75 patients to obtain 60 evaluable patients.

Conditions

• Primary Sclerosing Cholangitis (PSC)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-01
• Primary completion: 2028-03-01
• Completion: 2029-02-01
• First posted: 2024-11-21
• Last updated: 2025-10-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study