Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
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ClinicalTrials.gov Identifier: NCT04480840 |
Recruitment Status :
Recruiting
First Posted : July 21, 2020
Last Update Posted : November 29, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Primary Sclerosing Cholangitis | Drug: PLN-74809 Drug: Placebo | Phase 2 |
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 : | July 31, 2023 |
Estimated Study Completion Date : | August 31, 2023 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo |
Drug: Placebo
Placebo |
Experimental: PLN-74809 Dose Level 1
Dose: 40 mg;
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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
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Drug: PLN-74809
PLN-74809 |
- 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
- Assessment of PLN-74809 plasma concentrations [ Time Frame: 12 weeks ]Plasma PLN-74809 concentrations (total and unbound concentrations) at each sampling timepoint
- 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

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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 |
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.

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

Study Director: | Pliant Therapeutics Medical Monitor | Pliant Therapeutics, Inc. |
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: | November 29, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Cholangitis Cholangitis, Sclerosing Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases |