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PLN-74809

Pliant Therapeutics of PLN-74809 in PSC Patients

INTEGRIS-PSC

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?

  1. Check how suitable you are by looking at the information below.
  2. Check our map to see if you can get to a study site.
  3. 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.
  4. Got a question? Our Clinical Trials Guide has lots of information about how to join clinical trials, switching hospitals for trials and what's involved.
  5. Contact us if you need any help.

As this trial is not yet recruiting in the UK, there are no study sites to contact yet. Watch this space!

Key information

 

Trial Name INTEGRIS-PSC (PLN-74809-203)
ClinicalTrials.gov Identifier NCT04480840
Phase Phase 2a trial
Intervention Oral tablet
Recruiting now? Actively recruiting in US, Canada and Australia. UK and other EU sites expected to open in late 2020 or early 2021
Participating Centres To be updated as UK sites are activated

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? ALP should be at least 1.5 times the upper limit of the normal range (ULN) at screening. For those over 19 years old, this is 193 U/L for men, 156 U/L for women.
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 are listed for or who have had a transplant cannot take part
Is cirrhosis allowed? No
Previous studies and information See Pliant website
Are travel expenses covered? Patients will be reimbursed for reasonable travel and overnight stays 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, 12-week treatment and 4-week post-treatment follow-up (a total of 22 weeks)
Basic design of study Randomised, placebo controlled with a 3:1 randomisation (75% chance of getting study drug)
Link to Sponsor Pliant Therapeutics

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