Actively Recruiting
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
Led by LISCure Biosciences · Updated on 2025-10-24
87
Participants Needed
7
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
CONDITIONS
Official Title
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosis of primary sclerosing cholangitis (PSC) confirmed by cholangiographic evidence per AASLD guidelines
- Alkaline phosphatase (ALP) levels greater than 1.5 times the upper limit of normal at screening
- PSC patients with or without inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- Stable dose of biologic or advanced therapeutic treatments, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins for at least 3 months prior to and including Day 0, with plan to remain stable throughout the study
- Stable dose of ursodeoxycholic acid (not exceeding 23 mg/kg/day) for more than 3 months prior to screening
- Agreement to stop all probiotics for at least 2 weeks prior to treatment
- Patient is unable to conceive and/or patient’s partner is unable to become pregnant and/or agrees to use effective contraception when engaging in heterosexual intercourse
You will not qualify if you...
- Treatment with any investigational agents within 3 months or 5 half-lives prior to treatment or during the study; gene therapy or unknown half-life investigational agents not allowed
- History of liver transplant or anticipated need for liver transplant within 1 year
- Evidence of significant worsening of liver function
- Compensated or decompensated cirrhosis confirmed by histology, medical complications, or lab results
- Model for end-stage liver disease (MELD) score greater than 12 (except if due to anticoagulant therapy, vitamin deficiency, or kidney disease) for both parts of the study
- Small-duct PSC without large duct PSC
- Secondary causes of sclerosing cholangitis including IgG4 associated sclerosing cholangitis
- History of cholangiocarcinoma, gallbladder cancer, or hepatocellular carcinoma
- History of malignancy with lymph node or regional metastases within 5 years or current active malignancy treatment
- Chronic use of antibiotics, antibiotic use in last month, or prior use of Rebyota or Vowst for C. difficile infection
- Ulcerative colitis patients with partial Mayo score above 6 or Crohn's disease patients with CDAI above 220
- Chronic kidney injury
- Recent acute cholangitis within 90 days
- Presence of biliary drain or stent, total proctocolectomy with ileal anal pouch, partial large bowel resections, or history of small bowel resection
- Other liver diseases such as autoimmune hepatitis, primary biliary cholangitis, AIH/PSC overlap syndrome, alpha-1-antitrypsin deficiency, viral hepatitis, iron overload, Wilson disease, nonalcoholic steatohepatitis, alcohol-related liver disease
- Positive serology for hepatitis B surface antigen, hepatitis C virus antibody, detectable HCV RNA, or HIV antibodies
- Active drug or alcohol abuse disorder
- Female patients who are pregnant, nursing, or planning pregnancy during the study
- Clinically significant or active infection
- Severe immunosuppression with absolute neutrophil count below 500 cells/mL or judged by investigator to be at high risk of infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
University of California Davis
Sacramento, California, United States, 95817
Not Yet Recruiting
2
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
5
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
6
The Vanderbilt Clinic
Nashville, Tennessee, United States, 37232
Actively Recruiting
7
Liver institute Northwest
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
L
LISCure Biosciences Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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