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Tests treatment safety and results for Primary Sclerosing Cholangitis (PSC)
Official title A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC
ClinicalTrials.gov ID: NCT06699121
What this study is testing
What is LB-P8 low-dose?
LB-P8 low-dose is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for primary sclerosing cholangitis (psc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)...
- 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...
You likely 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...
- 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
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Aurora, Colorado, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- Nashville, Tennessee, United States
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Aurora, Colorado, United States; Iowa City, Iowa, United States; Baltimore, Maryland, United States; Rochester, Minnesota, United States; Nashville, Tennessee, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.