A Study of LB-P8 for Primary Sclerosing Cholangitis (PSC)
This study is testing a drug called LB-P8 for people with Primary Sclerosing Cholangitis (PSC), a chronic liver disease. The main goals are to see if LB-P8 is safe and how well it works. You might be able to join if you are between 18 and 75 years old and have a PSC diagnosis confirmed by specific imaging tests. Your Alkaline Phosphatase (ALP) levels, a marker of liver health, must also be elevated. The study will look at the safety of two different doses of LB-P8 over 4 to 24 weeks, and how much ALP levels change. The study is currently unclear on its recruitment status and plans to enroll up to 87 participants.
- Study design
- This is a Phase 2, randomized, double-blind, placebo-controlled study. It will involve up to 87 adult participants with PSC, who will receive either a low dose of LB-P8, a high dose of LB-P8, or a placebo.
- What's involved
- You would take one capsule by mouth once a day. The study will assess safety and tolerability for up to 24 weeks of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes up to 24 weeks of treatment from the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06699121
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
Recruiting
PHASE2Ages 18–75InterventionalTreatmentLISCure Biosciences
~87 participants
Updated 2025-10-24 on ClinicalTrials.gov
What's tested:LB-P8 low-doseLB-P8 high-dosePlacebo
At a glance
Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability of 2 different doses of LB-P8
Measured over (Part 1) Up to 4 weeks of treatment from the Baseline
+2 more outcomes measured
Conditions
Where it's being run
7 sites across 7 statesCalifornia1
Colorado1
Iowa1
Maryland1
Minnesota1
Tennessee1
Washington1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age: 18 to 75 years
A diagnosis of PSC based on cholangiographic evidence of PSC in accordance with American Association for the Study of Liver Diseases (AASLD) guidelines
ALP \>1.5 times the ULN at screening
PSC with or without IBD, such as ulcerative colitis or Crohn's disease
If patients are being administered biologic or advanced therapeutic treatments, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins, they must be on a stable dose for ≥3 months prior to, and including, Day 0 and plan to remain on a stable dose throughout the study
If patients are receiving ursodeoxycholic acid, they must be on a stable dose (not exceeding 23 mg/kg/day) for \>3 months prior to screening
Patient agrees to stop all probiotics for at least 2weeks prior to treatment
Patient is unable to conceive and/or patient who's partner is unable to become pregnant and/or agree to use effective methods of contraception when engaging in heterosexual intercourse
Exclusion
Treatment with any investigational agents within 3 months or 5 half-lives, whichever is longer prior to treatment or during the study. Gene therapy or other long-lasting investigational agents with unknown half-life is not allowed
History of a liver transplant or anticipated need for a liver transplant within 1 year
Patients who show evidence of significant worsening of hepatic function will be excluded.
Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters
Model for end-stage liver disease (MELD) score as below, unless the MELD is driven by anticoagulant therapy, vitamin deficiency, or kidney disease:
MELD Score of \>12 (decompensated cirrhosis) for Part 1 of the study
MELD Score of \>12 for Part 2 of the study
Small-duct PSC (in the absence of large duct PSC)
Secondary causes of sclerosing cholangitis including IgG4 associated sclerosing cholangitis
Any history of cholangiocarcinoma, gallbladder cancer, or hepatocellular carcinoma
History of any malignancy with lymph node or regional metastases within 5 years or current malignancy undergoing active treatment
Patients who require chronic use of antibiotics, received antibiotics in the last 1 month, or received Rebyota or Vowst (applicable for patients with Clostridioides difficile infection)
In patients with ulcerative colitis, partial Mayo score of \>6 or, patients with Crohn's disease if CDAI of \>220
Chronic kidney injury
Recent acute cholangitis (within 90 days)
Patients with indwelling biliary drain (or stent), total proctocolectomy with ileal anal pouch, partial large bowel resections or history of small bowel resection
Other causes of liver disease, such as autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), AIH/PSC overlap syndrome, alpha-1-antitrypsin deficiency, viral hepatitis, iron overload syndrome, Wilson disease, nonalcoholic steatohepatitis, and/or alcohol related liver disease. Additionally, positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) (detectable HCV RNA in the serum), or human immunodeficiency virus antibodies (anti HIV)
Active drug (known or suspected use of illicit drugs or drugs of abuse) or alcohol abuse disorder
Female patients who are pregnant, nursing, or planning to become pregnant during the study
Clinically significant and/or active infection
Subjects with a greater degree of immunosuppression, as evidenced by Alsolute neutrophil count \<500 cells/mL or in the investigator's judgement immunosuppressed and at higher risk of infection
What this trial measures
- Safety and tolerability of 2 different doses of LB-P8(Part 1) Up to 4 weeks of treatment from the Baseline
Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0
- Safety and tolerability of LB-P8(Part 2) Up to 24 weeks of treatment from the Baseline
Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0
- Mean percent change from baseline in Serum Concentrations of Alkaline Phosphatase (ALP)(Part 2) Up to 24 weeks of treatment from the Baseline