LB-P8 for Primary Sclerosing Cholangitis

Recruiting at 3 trial locations

Overseen By LISCure Biosciences Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: LISCure Biosciences

Must not be taking: Antibiotics, Rebyota, Vowst

Disqualifiers: Liver transplant, Cirrhosis, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

87 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial requires that if you are taking certain medications like biologics, immunosuppressants, corticosteroids, obeticholic acid, fibrates, or statins, you must be on a stable dose for at least 3 months before and during the study. You will need to stop taking probiotics at least 2 weeks before starting the treatment.

What safety data exists for LB-P8 (also known as obeticholic acid) in humans?

The safety of obeticholic acid has been evaluated in patients with primary biliary cholangitis, showing it can reduce certain liver-related biomarkers and potentially decrease the risk of liver transplantation or death. However, specific safety data for primary sclerosing cholangitis is not provided in the available research. ^{1 2 3 4 5}

How does the drug LB-P8 differ from other treatments for primary sclerosing cholangitis?

Primary sclerosing cholangitis currently has no effective medical or surgical treatments, making any new drug like LB-P8 potentially unique simply by offering a new option. Existing treatments focus on managing symptoms and complications, so LB-P8 may provide a novel approach if it targets the underlying disease process. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for patients with a liver condition called primary sclerosing cholangitis (PSC). Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of PSC.

Inclusion Criteria

ALP >1.5 times the ULN at screening

I am between 18 and 75 years old.

PSC with or without IBD

Exclusion Criteria

I have been diagnosed with small-duct primary sclerosing cholangitis.

My ulcerative colitis or Crohn's disease has a specific severity score.

Treatment with investigational agents within specified timeframe

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Evaluation of safety and tolerability of 2 pre-selected dose levels of LB-P8 in adult patients with PSC

4 weeks

Treatment Part 2

Evaluation of safety and efficacy in adult patients with PSC, randomized to receive low-dose LB-P8, high-dose LB-P8, or placebo

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• LB-P8

Trial Overview The study is testing the safety and effectiveness of LB-P8 at two different doses compared to a placebo. Participants will be randomly assigned to receive either a low dose of LB-P8, a high dose of LB-P8, or a placebo.

Participant Groups

Group I: LB-P8 low-dose Experimental Treatment 1 Intervention

Oral capsule, 1×10\^10 CFU/day

Group II: LB-P8 high-dose Experimental Treatment 1 Intervention

Oral capsule, 1×10\^11 CFU/day

Group III: Placebo Placebo Group 1 Intervention

Oral capsule, placebo

Who Is Running the Clinical Trial?

LISCure Biosciences

Lead Sponsor

Trials

2

Recruited

120+

Findings from Research

In a study of 21 patients with primary sclerosing cholangitis (PSC) treated with 9 mg of oral budesonide daily for one year, there was a slight improvement in liver enzyme levels, but overall benefits were minimal.

The treatment was associated with significant bone mass loss, indicating a risk of osteoporosis, and two patients required evaluation for liver transplantation, suggesting potential safety concerns with budesonide in PSC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral budesonide in the treatment of primary sclerosing cholangitis. Angulo, P., Batts, KP., Jorgensen, RA., et al.[2015]

Primary sclerosing cholangitis (PSC) is a progressive liver disease with no effective treatments currently available, and it often leads to serious complications like cirrhosis and bile duct cancer over a long period, typically a decade or more.

Management of PSC focuses on symptom relief and addressing complications, with options like balloon dilatation for strictures and liver transplantation for advanced cases, while experimental therapies such as immunosuppressive and choleretic agents are being tested in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fifth Carlos E. Rubio Memorial Lecture. Sclerosing cholangitis: pathogenesis, pathology, and practice. Larusso, NF.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of obeticholic acid for patients with primary biliary cholangitis: 3-year results of an international open-label extension study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical application of the GLOBE and United Kingdom-primary biliary cholangitis risk scores in a trial cohort of patients with primary biliary cholangitis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Greater Transplant-Free Survival in Patients Receiving Obeticholic Acid for Primary Biliary Cholangitis in a Clinical Trial Setting Compared to Real-World External Controls. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Oral budesonide in the treatment of primary sclerosing cholangitis. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

A real-world observational cohort of patients with primary biliary cholangitis: TARGET-primary biliary cholangitis study design and rationale. [2020]

6. Puerto Rico pubmed.ncbi.nlm.nih.gov

The Fifth Carlos E. Rubio Memorial Lecture. Sclerosing cholangitis: pathogenesis, pathology, and practice. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Primary sclerosing cholangitis. [2009]

8. Mexico pubmed.ncbi.nlm.nih.gov

Multiple therapeutic targets in rare cholestatic liver diseases: Time to redefine treatment strategies. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Current concepts. Primary sclerosing cholangitis. [2013]

10. Japan pubmed.ncbi.nlm.nih.gov

Diagnosis of primary sclerosing cholangitis. [2019]