Recruiting
Phase 2

LB-P8

Sponsor:

LISCure Biosciences

Code:

NCT06699121

Conditions

Primary Sclerosing Cholangitis (PSC)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LB-P8 low-dose

LB-P8 high-dose

Placebo

Study Details

Brief summary:

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

Conditions

Primary Sclerosing Cholangitis (PSC)

Study ID

NCT06699121

Start date

Nov, 2025

Status verified date

Oct, 2025

Completion date

Feb, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

87 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LB-P8 low-dose

Oral capsule, 1×10\^10 CFU/day

experimental: LB-P8 high-dose

Oral capsule, 1×10\^11 CFU/day

placebo comparator: Placebo

Oral capsule, placebo

Interventions

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

Primary outcome measure

  • Safety and tolerability of 2 different doses of LB-P8 [ Time Frame: (Part 1) Up to 4 weeks of treatment from the Baseline ]
  • Safety and tolerability of LB-P8 [ Time Frame: (Part 2) Up to 24 weeks of treatment from the Baseline ]
  • Mean percent change from baseline in Serum Concentrations of Alkaline Phosphatase (ALP) [ Time Frame: (Part 2) Up to 24 weeks of treatment from the Baseline ]

Central Contacts and Locations

Central contacts

LISCure Biosciences Clinical Trials

+82317061710clinical@liscure.bio

Locations

University Of Iowa Hospitals And Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

University Of Iowa Hospitals And Clinics

319-356-1616

Principal Investigator:

Alan Gunderson, MD

Mercy Medical Center

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

Mercy Medical Center

410-332-9000

Principal Investigator:

Paul Thuluvath, MD

The Vanderbilt Clinic

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

The Vanderbilt Clinic

615-322-5000

Principal Investigator:

Manhal Izzy, MD

Liver institute Northwest

Recruiting

Seattle, Washington, United States, 98105

Contacts

Liver institute Northwest

206-536-3030info@liverinstitutenw.org

Principal Investigator:

Kris Kowdley, MD

More Information

Sponsor

LISCure Biosciences

Last update posted

Oct 24, 2025

Last verified

Oct, 2025

Keywords

  • PSC
  • Pruritus
  • Inflammatory bowel disease
  • IBD
  • Itch
  • Cholestasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by LISCure Biosciences on 2025-10-24.