This study is not yet accepting patients
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
a study on Primary Sclerosing Cholangitis
Summary
- Eligibility
- for people ages 18-75 (full criteria)
- Location
- at UC Davis
- Dates
- study startedcompletion around
- Principal Investigator
- by Christopher Bowlus, MD (ucdavis)
Description
Summary
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
Official Title
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)
Details
This is phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of LB-P8 in adult patients with primary sclerosing cholangitis(PSC).
- Part 1 will evaluate safety and tolerability of 2 pre-selected dose level of LB-P8 (low-dose[1×1010 CFU/capsule] and high dose [1×1011 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(1×1010 CFU/capsule), high-dose LB-P8(1×1011 CFU/capsule) or matched placebo capsule. Part 2 plans to enroll and randomize 75 patients to obtain 60 evaluable patients.
Keywords
Primary Sclerosing Cholangitis (PSC), PSC, Pruritus, Inflammatory bowel disease, IBD, Itch, Cholestasis, Cholangitis, Sclerosing Cholangitis, LB-P8 low-dose, LB-P8 high-dose
Eligibility
You can join if…
Open to people ages 18-75
- 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
You CAN'T join if...
- 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
Locations
- University of California Davis
Sacramento California 95817 United States - Liver institute Northwest
Seattle Washington 98105 United States - UCHealth University of Colorado Hospital
Aurora Colorado 80045 United States - Mayo Clinic
Rochester Minnesota 55905 United States
Lead Scientist at University of California Health
- Christopher Bowlus, MD (ucdavis)
Professor in Residence, MED: Int Med Gastroenterology, School of Medicine. Authored (or co-authored) 220 research publications
Details
- Status
- not yet accepting patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- LISCure Biosciences
- ID
- NCT06699121
- Phase
- Phase 2 Primary Sclerosing Cholangitis Research Study
- Study Type
- Interventional
- Participants
- Expecting 87 study participants
- Last Updated