A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
ConditionPrimary Sclerosing Cholangitis (PSC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLISCure Biosciences
About this trial
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
LB-P8 low-dose
DrugOne capsule QD (1×10\^10 CFU/day) oral administration
LB-P8 high-dose
DrugOne capsule QD (1×10\^11 CFU/day) oral administration
Placebo
DrugOne capsule QD oral administration
Treatment groups
87 Participants
are divided into 3 treatment groupsGroup A: LB-P8 low-doseExperimental treatment 1 intervention
Group B: LB-P8 high-doseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of 2 different doses of LB-P8
Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0
Time frame
(Part 1) Up to 4 weeks of treatment from the Baseline2
Safety and tolerability of LB-P8
Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0
Time frame
(Part 2) Up to 24 weeks of treatment from the Baseline3
Mean percent change from baseline in Serum Concentrations of Alkaline Phosphatase (ALP)
Time frame
(Part 2) Up to 24 weeks of treatment from the BaselineSecondary outcomes
1
Change from baseline in ALP
Time frame
(Part 2) Up to 24 weeks of treatment from the Baseline2
Percentage of patients who achieve ALP of <1.5 × upper limit of normal (ULN)
Time frame
(Part 2) Up to 24 weeks of treatment from the Baseline3
Change from baseline in enhanced liver fibrosis (ELF™)
Hyaluronic acid, procollagen-3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1 will be assessed in blood for ELF test.
Time frame
(Part 2) Up to 24 weeks of treatment from the Baseline4
Changes from baseline in biliary metrics (biliary strictures and dilatations)
Biliary metrics (biliary strictures and dilatations) will be assessed by magnetic resonance cholangiopancreatography (MRCP)
Time frame
(Part 2) Up to 24 weeks of treatment from the BaselineSponsors and contacts
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Source ClinicalTrials.gov