Primary Sclerosing Cholangitis (PSC)Phase 2NCT06699121
A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
A Phase 2 study testing LB-P8 low-dose and LB-P8 high-dose in people with Primary Sclerosing Cholangitis (PSC), run by LISCure Biosciences at 7 sites in United States.
Trial summary
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Sclerosing Cholangitis (PSC)
- What is being tested?
- LB-P8 low-dose and LB-P8 high-dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2025to Feb 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
UCHealth University of Colorado Hospital, 7208480000
Lisa Forman, MD
- Recruiting
Mercy Medical Center
Baltimore, Maryland, 21202
Mercy Medical Center, 410-332-9000
Paul Thuluvath, MD
- Recruiting
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
University Of Iowa Hospitals And Clinics, 319-356-1616
Alan Gunderson, MD
- Recruiting
The Vanderbilt Clinic
Nashville, Tennessee, 37232
The Vanderbilt Clinic, 615-322-5000
Manhal Izzy, MD
- Not yet recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic, 507-284-2511
John Eton, MD
- Not yet recruiting
University of California Davis
Sacramento, California, 95817
University of California Davis, 800-282-3284
Christopher Bowlus, MD
- Recruiting
Liver institute Northwest
Seattle, Washington, 98105
Liver institute Northwest, 206-536-3030, info@liverinstitutenw.org
Kris Kowdley, MD
About this study
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)
The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
Read the detailed description
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[1×10^10 CFU/capsule] and high dose [1×10^11 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(1×10^10 CFU/capsule), high-dose LB-P8(1×10^11 CFU/capsule) or matched placebo capsule. Part 2 plans to enroll and randomize 75 patients to obtain 60 evaluable patients.
- Conditions
- Primary Sclerosing Cholangitis (PSC)
- Being tested
- LB-P8 low-dose, LB-P8 high-dose, Placebo
- Keywords
- PSC, Pruritus, Inflammatory bowel disease, IBD, Itch, Cholestasis
- Medical subject headings
- Cholangitis, Sclerosing, Pruritus, Inflammatory Bowel Diseases, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-P8 low-doseDrug
One capsule QD (1×10^10 CFU/day) oral administration
LB-P8 high-doseDrug
One capsule QD (1×10^11 CFU/day) oral administration
PlaceboDrug
One capsule QD oral administration
| Study group | Role | What they receive |
|---|---|---|
| LB-P8 low-dose | Experimental | Oral capsule, 1×10^10 CFU/day Receives: Drug: LB-P8 low-dose |
| LB-P8 high-dose | Experimental | Oral capsule, 1×10^11 CFU/day Receives: Drug: LB-P8 high-dose |
| Placebo | Placebo comparator | Oral capsule, placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: (Part 1) Up to 4 weeks of treatment from the Baseline
Safety and tolerability of LB-P8
Occurrence of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) by CTCAE V5.0
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Mean percent change from baseline in Serum Concentrations of Alkaline Phosphatase (ALP)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Secondary outcomes (13)
Change from baseline in ALP
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Percentage of patients who achieve ALP of <1.5 × upper limit of normal (ULN)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
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.
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Changes from baseline in biliary metrics (biliary strictures and dilatations)
Biliary metrics (biliary strictures and dilatations) will be assessed by magnetic resonance cholangiopancreatography (MRCP)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Changes from baseline in liver stiffness
Liver stiffness will be measured by transient elastography (FibroScan®)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in alanine aminotransferase (ALT)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in aspartate aminotransferase (AST)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in gamma glutamyl transferase (GGT)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in prothrombin time (PT) and partial prothrombin time (PTT)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in international normalized ratio (INR)
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in total and direct bilirubin
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Change from baseline in fasting serum bile acid level
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
The percentage of patients who experience liver disease progression
The percentage of patients who experience progression to cirrhosis, clinical decompensation rates, liver transplant, newly diagnosed cholangiocarcinoma, MELD score increase from <12 to >15 and Death from any cause
Measured: (Part 2) Up to 24 weeks of treatment from the Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study startNov 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing Cholangitis (PSC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LISCure Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699121
- Sponsor's protocol ID
- LB08-211
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2024
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No