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PLN-74809 for Sclerosing Cholangitis

Phase 2
Waitlist Available
Research Sponsored by Pliant Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-48 weeks
Awards & highlights

Study Summary

This trial is studying a potential new treatment for primary sclerosing cholangitis and liver fibrosis. It is assessing the safety and tolerability of the drug as well as how it is processed by the body.

Who is the study for?
This trial is for people with a condition called primary sclerosing cholangitis (PSC), which affects the liver's bile ducts. Participants should have abnormal liver tests or suspected liver fibrosis, but not advanced cirrhosis. They can be on stable IBD treatment and must not have other causes of liver disease like autoimmune hepatitis or viral infections.Check my eligibility
What is being tested?
The study is testing PLN-74809, a potential new medication for PSC, against a placebo (a substance with no active drug). It's designed to see how safe it is and how the body processes it. People will be randomly assigned to receive either PLN-74809 or placebo without knowing which one they're getting.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones in trials like this may include gastrointestinal symptoms, headaches, fatigue, and possible allergic reactions. The safety profile of PLN-74809 will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have suspected liver fibrosis confirmed by a specific liver test or biopsy.
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I am on a stable treatment for IBD and it will not change during the study.
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I have been on a stable dose of UDCA, less than 25 mg/kg/day, for over 3 months.
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I have been diagnosed with large duct PSC based on specific liver tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events and laboratory abnormalities, as assessed by CTCAE v5.0
Secondary outcome measures
Assessment of PLN-74809 plasma concentrations
Other outcome measures
Changes from Baseline to Week 12 in liver fibrosis biomarkers and alkaline phosphatase (ALP) levels

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: PLN-74809 Dose Level 4Experimental Treatment1 Intervention
Dose: 320 mg; PLN-74809 Dose Level 4 following PLN-74809 Dose Level 3
Group II: PLN-74809 Dose Level 3Experimental Treatment1 Intervention
Dose: 160 mg; PLN-74809 Dose Level 3 following PLN-74809 Dose Level 2
Group III: PLN-74809 Dose Level 2Experimental Treatment1 Intervention
Dose: 80 mg; PLN-74809 Dose Level 2 following PLN-74809 Dose Level 1
Group IV: PLN-74809 Dose Level 1Experimental Treatment1 Intervention
Dose: 40 mg;
Group V: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PLN-74809
2020
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Pliant Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
519 Total Patients Enrolled
Pliant Therapeutics Medical MonitorStudy DirectorPliant Therapeutics, Inc.
4 Previous Clinical Trials
473 Total Patients Enrolled

Media Library

Placebo (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04480840 — Phase 2
Primary Sclerosing Cholangitis Research Study Groups: PLN-74809 Dose Level 1, PLN-74809 Dose Level 3, Placebo, PLN-74809 Dose Level 4, PLN-74809 Dose Level 2
Primary Sclerosing Cholangitis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04480840 — Phase 2
Placebo (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04480840 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In which geographical areas is this research currently being conducted?

"This research trial is currently taking place at 31 sites, including Philadelphia, Ottawa and Edmonton. To minimize travel obligations if you choose to join this study, it would be prudent to select the closest location."

Answered by AI

How many individuals are actively involved in the current clinical trial?

"To run this clinical trial, 84 participants fitting the inclusion criteria are necessary. The sponsor company Pliant Therapeutics, Inc., will manage these trials at two different sites - Perelman Center for Advanced Medicine in Philadelphia and The Ottawa Hospital in Ottawa."

Answered by AI

Who meets the qualifications for participation in this clinical experiment?

"This medical trial requires 84 participants aged between 18 and 75 who are afflicted with cholangitis sclerosing. Additionally, they must have serum ALP concentrations more than the upper limit of normal (ULN) while their AST/ALT levels should be less than 5 times ULN. Patients that currently receive treatment for IBD can participate as long as they maintain a stable dose throughout the course of this study; furthermore, an abnormal imaging test result from MRCP/ERCP/PTC is needed to establish diagnosis of large duct PSC. To assess liver fibrosis, either TE FibroScan or ELF Score or a historical"

Answered by AI

Are individuals aged 35 and over eligible to join this medical experiment?

"This clinical trial has established criteria for participants to be included, setting the lower limit at 18 years old and upper boundary of 75. There are 4 specific studies that require minors and 41 specifically targeting senior citizens."

Answered by AI

What adverse effects has PLN-74809 been associated with?

"We rate the safety of PLN-74809 as a 2, which is indicative that there has been some data collected supporting its general safe use but no information on efficacy from clinical trials."

Answered by AI

Is there still availability to join this research endeavor?

"Clinicaltrials.gov specifies that this trial is actively seeking participants, with its initial post dating back to July 27th 2020 and the most recent update occurring on November 28th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)
2020. "Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04480840.
~24 spots leftby Apr 2025
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