LB-P8 treatment for adults with primary sclerosing cholangitis
A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating the Safety and Efficacy of LB P8 in Patients With Primary Sclerosing Cholangitis (PSC)
This trial will test whether two doses of LB-P8 can lower abnormal liver tests and help symptoms like itching in adults with PSC.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | LISCure Biosciences Industry-sponsored |
| Locations | 7 sites (Sacramento, California and 6 other locations) |
| Trial ID | NCT06699121 on ClinicalTrials.gov |
What this trial studies
This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study testing two dose levels of the live biotherapeutic LB-P8 in adults with PSC. Part 1 uses a 3+3 design to evaluate safety and tolerability of a low dose (1×10^10 CFU/capsule) and a high dose (1×10^11 CFU/capsule) in up to 12 patients. Part 2 randomizes eligible patients 1:1:1 to low-dose LB-P8, high-dose LB-P8, or matched placebo and plans to enroll 75 patients to obtain 60 evaluable subjects. The study focuses on safety and efficacy outcomes including cholestatic liver biochemistry and symptoms such as pruritus, with participants required to be on stable background medications and to stop probiotics before dosing.
Who should consider this trial
Good fit: Adults 18–75 with a cholangiographic diagnosis of PSC and an alkaline phosphatase >1.5×ULN who are on stable doses of other liver or immune medications and can stop probiotics before treatment are ideal candidates.
Not a fit: Patients with normal ALP, unstable or recently changed immunosuppressive/IBD treatments, those who are pregnant or cannot use effective contraception, or those with advanced decompensated liver disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, LB-P8 could reduce cholestatic liver enzyme levels and improve symptoms such as itching for people with PSC.
How similar studies have performed: Microbiome-targeted therapies for PSC are experimental; small studies of antibiotics and fecal microbiota transplant have shown mixed signals but no established effective therapy, so this approach remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sacramento, California and 6 other locations
- University of California Davis — Sacramento, California, United States (Not_yet_recruiting)
- UCHealth University of Colorado Hospital — Aurora, Colorado, United States (Not_yet_recruiting)
- University Of Iowa Hospitals And Clinics — Iowa City, Iowa, United States (Recruiting)
- Mercy Medical Center — Baltimore, Maryland, United States (Recruiting)
- Mayo Clinic — Rochester, Minnesota, United States (Not_yet_recruiting)
- The Vanderbilt Clinic — Nashville, Tennessee, United States (Recruiting)
- Liver institute Northwest — Seattle, Washington, United States (Recruiting)
Study contacts
- Study coordinator: LISCure Biosciences Clinical Trials
- Email: clinical@liscure.bio
- Phone: +82317061710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.