LB-P8 for Primary Sclerosing Cholangitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called LB-P8 for individuals with primary sclerosing cholangitis (PSC), a liver disease that damages bile ducts. Researchers aim to determine the safety and effectiveness of LB-P8. Participants will receive either a low dose, a high dose, or a placebo (inactive substance) to compare outcomes. Those with PSC who also have stable inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, and are not using probiotics might be suitable for the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
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.
Is there any evidence suggesting that LB-P8 is likely to be safe for humans?
Research has shown that LB-P8 has been safe in earlier studies. Tests on animals and initial human trials indicate that people generally tolerate LB-P8 well. These studies also suggest it might help with inflammatory conditions. In earlier phases, researchers found no major safety issues, which is promising for ongoing research. While LB-P8 is still under study, past tests with humans have shown it to be safe. This ongoing trial will closely monitor safety to confirm these results.12345
Why do researchers think this study treatment might be promising for primary sclerosing cholangitis?
Most treatments for primary sclerosing cholangitis (PSC) focus on managing symptoms with medications like ursodeoxycholic acid, but LB-P8 offers a new approach. LB-P8 is unique because it utilizes probiotics in the form of oral capsules, aiming to modulate the gut microbiome, which may play a role in PSC. Researchers are excited about LB-P8 because it is offered in both low-dose and high-dose options, potentially allowing for tailored treatment strategies. This probiotic approach could represent a gentler and more targeted strategy compared to traditional therapies, potentially improving liver health from within.
What evidence suggests that LB-P8 might be an effective treatment for primary sclerosing cholangitis?
Research suggests that LB-P8 might help treat primary sclerosing cholangitis (PSC). In studies with mice, a four-week regimen of LB-P8 reduced inflammation and scarring related to this disease. LB-P8 has also shown benefits for inflammatory bowel disease (IBD), which often occurs with PSC. These findings indicate that LB-P8 could help lower inflammation associated with PSC. While research in humans is ongoing, these early results are promising for LB-P8 as a potential treatment. Participants in this trial will receive either a low dose or high dose of LB-P8, or a placebo, to further evaluate its effectiveness in treating PSC.12367
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Evaluation of safety and tolerability of 2 pre-selected dose levels of LB-P8 in adult patients with PSC
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LB-P8
Find a Clinic Near You
Who Is Running the Clinical Trial?
LISCure Biosciences
Lead Sponsor