PLN-74809
FULLY RECRUITED IN THE UK - EARLY RESULTS PUBLISHED Sep '23 and Jul '24
PLN-74809-PSC-203
About PLN-74809
PLN-74809 directly acts on the development of liver and bile duct fibrosis (scarring) by blocking the activity of a protein in your body called TGF-beta. This is different than UDCA or other medications that mainly improve bile flow and inflammation.
Thinking of taking part?
- Check how suitable you are by looking at the information below.
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- Contact the research team for more details if you think you are suitable. Check back regularly as we are adding more contact info every day.
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Key information (updated 10 May 2024)
| Trial Name | PLN-74809-PSC-203 |
| ClinicalTrials.gov Identifier | NCT04480840 |
| Phase | Phase 2a trial |
| Intervention | Oral tablet once a day |
| Recruiting now? | FULLY RECRUITED |
| Participating Centres | See current sites list on Clinicaltrials.gov or contact clinicaltrials@pliantrx.com |
| Liver disease diagnosis | Confirmed large duct PSC |
| Age | 18 to 75 years old |
| Females: can I be pregnant? | No |
| Is IBD allowed? | Patients with IBD are allowed but must be on a stable treatment regimen for 12 weeks before Screening. Biologics, immunosuppressives and other therapies are all allowed. |
| Is there an ALP (alkaline phosphatase) requirement? | Serum (measured in a blood test) ALP should be within normal ranges or greater 1 time the upper limit of the normal range (ULN) at Screening. |
| Can I take UDCA (Urso)? | Yes. Both UDCA treated and untreated patients are allowed but must be at a stable dose for 12 weeks before Screening |
| Can I take part if I have a stent? | No stents allowed |
| Are recent acute cholangitis (ie bacterial cholangitis) attacks allowed? | Patients must be free of acute cholangitis infections for 60 days before Screening and no episodes during the Screening period |
| Can I take part if I have had a liver transplant? | Patients who have had a liver transplant cannot take part. You may be on the waiting list for the transplant but cannot have one scheduled. |
| Is cirrhosis allowed? | No |
| Previous studies and information | See Pliant website |
| Are travel expenses covered? | Patients will be reimbursed for reasonable travel and overnight if needed |
| Procedures and tests include: | Physical exams, blood and urine laboratory tests and patient surveys at most visits. FibroScan is required at Screening and end of treatment. MRI is optional. No liver biopsy is required for this study. |
| How many study visits will there be? How long will each study visit be? | A total of 8 visits which generally last 1-3 hours. Home health services are offered as part of the study and most visits can be conducted remotely if desired. |
| Duration of study | Up to 42-day Screening, Minimum 24-week - up to 48-week treatment and 4-week post-treatment follow-up (up to 58 weeks) |
| Basic design of study | Randomised, placebo controlled with a 3:1 randomisation (75% chance of getting study drug) |
| Link to Sponsor | Pliant Therapeutics |