What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include the antifibrotic agents nintedanib and pirfenidone. Nintedanib is associated with side effects such as diarrhea, nausea, vomiting, liver enzyme elevation, and anorexia. Pirfenidone commonly causes nausea, rash, fatigue, diarrhea, dyspepsia, and photosensitivity. Both medications aim to slow disease progression but come with a range of gastrointestinal and dermatological side effects that need to be managed under medical supervision.

What prior FDA approvals exist?

The FDA has approved two primary anti-fibrotic agents for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a receptor blocker for multiple tyrosine kinases that mediate fibrogenic growth factors, and it has been shown to slow the rate of disease progression in IPF. Pirfenidone is another anti-fibrotic agent that reduces the decline in lung function and has demonstrated efficacy in decreasing mortality related to IPF. Both drugs aim to manage fibrosis and improve patient outcomes, similar to the investigational agent PLN-74809, which targets type 1 collagen deposition in the lungs.

What other types of research exist?

Promising novel alternatives to PLN-74809 for IPF patients include: 1) Pirfenidone, which has shown efficacy in reducing disease progression and mortality in multiple clinical trials. 2) Nintedanib, a tyrosine kinase inhibitor that slows the decline in pulmonary function. 3) Pamrevlumab, an anti-connective tissue growth factor therapy, which has shown promise in phase 2 trials. These treatments have demonstrated potential in managing IPF and may be considered as alternatives.

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PLN-74809 for Idiopathic Pulmonary Fibrosis (PLN-74809 Trial)

Phase 2

Waitlist Available

Led By Sydney Montesi, MD

Research Sponsored by Pliant Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose

Awards & highlights

Summary

This trial is testing PLN-74809, a medication that may reduce lung scarring, in patients with Idiopathic Pulmonary Fibrosis (IPF). The goal is to see if it can lower the buildup of type 1 collagen in their lungs, potentially improving their breathing and lung function.

Who is the study for?

This trial is for adults aged 40 or older with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) within the last 8 years. They must have stable lung function and be on consistent treatment if taking IPF medications like nintedanib or pirfenidone. Smokers or those with recent infections, acute exacerbations, or using unapproved IPF treatments are excluded.

What is being tested?

The study tests PLN-74809's effect on lung collagen deposition in IPF patients compared to a placebo over 12 weeks. It's double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo, ensuring unbiased results.

What are the potential side effects?

While specific side effects for PLN-74809 aren't listed here, common ones for new fibrosis drugs can include gastrointestinal issues, skin reactions, fatigue, headache and potential liver enzyme abnormalities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening period (up to 28 days) to treatment period of 12 weeks, to 2 weeks after last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Secondary study objectives

Secondary Safety and Tolerability

Other study objectives

Exploratory 1

Exploratory 2

Side effects data

From 2022 Phase 2 trial • 9 Patients • NCT04072315

100%

Gamma-glutamyltransferase increased

100%

Hepatic Enzyme Increased

100%

80%

60%

40%

20%

Study treatment Arm

320 mg

80 mg and 240 mg

80 mg and 120 mg

60 mg

320 mg and 120 mg

120 mg and 240 mg

240 mg and 320 mg

120 mg and 320 mg

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PLN-74809Experimental Treatment1 Intervention

160 mg PLN-74809

Group II: PlaceboPlacebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PLN-74809

2020

Completed Phase 2

~260

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib and pirfenidone, both of which are antifibrotic agents. Nintedanib inhibits multiple tyrosine kinases involved in fibrotic processes, such as VEGF, FGF, and PDGF pathways. Pirfenidone reduces fibrosis by inhibiting TGF-β and TNF-α synthesis. Additionally, PLN-74809, an investigational drug, targets type 1 collagen deposition in the lungs. These treatments are significant for IPF patients as they aim to slow the progression of fibrosis, thereby preserving lung function and improving quality of life.