A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
NCT ID: NCT06699121
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
87 participants
INTERVENTIONAL
2025-11-30
2029-02-28
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LB-P8 low-dose
Oral capsule, 1×10\^10 CFU/day
LB-P8 low-dose
One capsule QD (1×10\^10 CFU/day) oral administration
LB-P8 high-dose
Oral capsule, 1×10\^11 CFU/day
LB-P8 high-dose
One capsule QD (1×10\^11 CFU/day) oral administration
Placebo
Oral capsule, placebo
Placebo
One capsule QD oral administration
Interventions
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LB-P8 low-dose
One capsule QD (1×10\^10 CFU/day) oral administration
LB-P8 high-dose
One capsule QD (1×10\^11 CFU/day) oral administration
Placebo
One capsule QD oral administration
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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LISCure Biosciences
INDUSTRY
Responsible Party
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Locations
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University of California Davis
Sacramento, California, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, United States
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States
Mercy Medical Center
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
The Vanderbilt Clinic
Nashville, Tennessee, United States
Liver institute Northwest
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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University of California Davis
Role: primary
UCHealth University of Colorado Hospital
Role: primary
University Of Iowa Hospitals And Clinics
Role: primary
Mercy Medical Center
Role: primary
Mayo Clinic
Role: primary
The Vanderbilt Clinic
Role: primary
Other Identifiers
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LB08-211
Identifier Type: -
Identifier Source: org_study_id
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