Actively Recruiting
A Phase 2 Randomized, Double Blind, Placebo Controlled Study Evaluating Safety and Efficacy of LB-P8 in Primary Sclerosing Cholangitis (PSC)
Led by LISCure Biosciences · Updated on 2025-10-24
87
Participants Needed
7
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
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 1x10^10 CFU per capsule and a high dose of 1x10^11 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.
CONDITIONS
Brief Title
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of primary sclerosing cholangitis based on cholangiographic evidence per AASLD guidelines
- Alkaline phosphatase (ALP) level greater than 1.5 times the upper limit of normal at screening
- PSC patients with or without inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- Stable dose of biologic or advanced therapies, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins for at least 3 months before and during the study
- Stable dose of ursodeoxycholic acid not exceeding 23 mg/kg/day for more than 3 months before screening
- Agreement to stop all probiotics for at least 2 weeks before treatment
- Participant or partner unable to conceive or agreement to use effective contraception during the study
You will not qualify if you...
- Treatment with investigational agents within 3 months or 5 half-lives before or during the study
- History of liver transplant or expected liver transplant within 1 year
- Evidence of worsening liver function or compensated/decompensated cirrhosis
- MELD score greater than 12 unless caused by anticoagulant therapy, vitamin deficiency, or kidney disease
- Small-duct PSC without large duct PSC
- Secondary causes of sclerosing cholangitis like IgG4 associated disease
- History of cholangiocarcinoma, gallbladder cancer, or hepatocellular carcinoma
- Recent or active malignancy with metastases or active treatment
- Chronic or recent antibiotic use or use of specific microbiome therapies
- Severe inflammatory bowel disease activity
- Chronic kidney injury
- Recent acute cholangitis within 90 days
- Presence of biliary drains or certain bowel surgeries
- Other liver diseases such as autoimmune hepatitis, viral hepatitis, iron overload, or alcohol-related liver disease
- Active drug or alcohol abuse
- Pregnant or nursing women
- Significant immunosuppression or active infections
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive one oral capsule daily of either low-dose LB-P8, high-dose LB-P8, or placebo for up to 24 weeks to assess safety and efficacy.
Weekly visits for up to 24 weeks
Trial Site Locations
Total: 7 locations
1
University of California Davis
Sacramento, California, United States, 95817
Not Yet Recruiting
2
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
6
The Vanderbilt Clinic
Nashville, Tennessee, United States, 37232
Actively Recruiting
7
Liver institute Northwest
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
L
LISCure Biosciences Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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