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Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480840
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Pliant Therapeutics, Inc.

Brief Summary:
A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis

Condition or disease Intervention/treatment Phase
Primary Sclerosing Cholangitis Drug: PLN-74809 Drug: Placebo Phase 2

Detailed Description:

Two-part study:

Part 1 - 12-week treatment period evaluating 40 mg of PLN-74809 or matching placebo Part 2 - 12-week treatment period evaluating two dose groups, 80 mg and 160 mg of PLN-74809 or matching placebo

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Dose-ranging, Placebo-controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Primary Sclerosing Cholangitis (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC)
Actual Study Start Date : July 27, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : October 31, 2022


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo

Experimental: PLN-74809 Dose Level 1
Dose: 40 mg;
Drug: PLN-74809
PLN-74809

Experimental: PLN-74809 Dose Level 2
Dose: 80 mg; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
Drug: PLN-74809
PLN-74809

Experimental: PLN-74809 Dose Level 3
Dose: 160 mg; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
Drug: PLN-74809
PLN-74809




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0 [ Time Frame: 12 weeks ]
    Nature and proportion of AEs between PLN-74809 and placebo groups


Secondary Outcome Measures :
  1. Assessment of PLN-74809 plasma concentrations [ Time Frame: 12 weeks ]
    Plasma PLN-74809 concentrations (total and unbound concentrations) at each sampling timepoint


Other Outcome Measures:
  1. Changes from Baseline to Week 12 in liver fibrosis biomarkers and alkaline phosphatase (ALP) levels [ Time Frame: 12 Weeks ]
    Absolute and relative changes from Baseline to Week 12 in liver fibrosis biomarkers (including PRO-C3 and ELF) and in ALP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established clinical diagnosis of large duct PSC based on an abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP), and/or percutaneous transhepatic cholangiopancreatography (PTC) in the context of cholestatic liver chemistry
  • Suspected liver fibrosis, as defined by liver stiffness measurement (LSM), assessed by ultrasound-based transient elastography (TE, FibroScan®) OR Enhanced Liver Fibrosis (ELF) Score OR Historical liver biopsy showing fibrosis without cirrhosis (by any scoring system) OR Magnetic resonance elastography (MRE)
  • Serum ALP concentration > 1 times the upper limit of normal (ULN)
  • Participants receiving treatment for IBD are allowed, if on a stable dose from screening and expected to remain stable for the duration of the study
  • Serum AST and ALT concentration ≤ 5 times the upper limit of normal
  • If receiving treatment with UDCA, therapy is at a dose of < 25 mg/kg/day, has been stable for at least 3 months before screening.

Exclusion Criteria:

  • Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
  • Known or suspected overlapping clinical and histologic diagnosis of autoimmune hepatitis
  • Small duct PSC (evidence of PSC on historical liver histology, with normal bile ducts on cholangiography)
  • Presence of liver cirrhosis as assessed by liver histology, ultrasound-based liver stiffness measurement, ELF score, MRE, and/or signs and symptoms of hepatic decompensation (including but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy.
  • Serum ALP concentration > 10 times the upper limit of normal.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480840


Contacts
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Contact: Pliant Therapeutics Medical Monitor clintrials@pliantrx.com clintrials@pliantrx.com

Locations
Show Show 47 study locations
Sponsors and Collaborators
Pliant Therapeutics, Inc.
Investigators
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Study Director: Pliant Therapeutics Medical Monitor Pliant Therapeutics, Inc.
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Responsible Party: Pliant Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04480840    
Other Study ID Numbers: PLN-74809-PSC-203
INTEGRIS-PSC ( Other Identifier: Pliant Therapeutics] )
First Posted: July 21, 2020    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases