What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are nintedanib and pirfenidone. Nintedanib often causes gastrointestinal side effects such as diarrhea and nausea, as well as liver enzyme elevations. Pirfenidone is associated with nausea, rash, and photosensitivity. Both medications can lead to decreased appetite and fatigue. These side effects are important considerations for patients and healthcare providers when managing IPF.

What prior FDA approvals exist?

The FDA has approved two main antifibrotic medications for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Both drugs have been shown to slow disease progression and reduce the frequency of acute exacerbations. Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factors involved in fibrosis, while pirfenidone has antifibrotic and anti-inflammatory properties. These treatments are not specifically integrin inhibitors like Bexotegrast, which targets integrin αvβ6 to reduce fibrosis, but they represent the current standard of care for managing IPF.

What other types of research exist?

Promising alternatives to Bexotegrast for IPF treatment include: 1) Nintedanib and Pirfenidone, which are antifibrotic agents that slow disease progression. 2) Tacrolimus, which has shown improved survival rates in combination with methylprednisolone. 3) Hemoperfusion with polymyxin-B immobilized fiber, which has demonstrated improved oxygenation and survival rates. These treatments are being actively researched and have shown potential benefits in clinical settings.

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Integrin Antagonist

Bexotegrast for Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

Research Sponsored by Pliant Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

≥ 40 years of age prior to screening

Be older than 18 years old

Must not have

Prior administration of bexotegrast

Hepatic impairment or end-stage liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Summary

This trial is testing a new medication called bexotegrast to see if it can help people with a lung disease called idiopathic pulmonary fibrosis (IPF). The study will include people who are already on other treatments as well as those who are not. The goal is to find out if bexotegrast can improve lung function and slow down the disease.

Who is the study for?

This trial is for adults over 40 with idiopathic pulmonary fibrosis diagnosed within the last 7 years, having certain lung function levels. Stable patients on IPF treatments or those not treated for at least 8 weeks can join. Exclusions include smokers, liver/kidney disease sufferers, recent cancer patients (except some skin/cervical cancers), pregnant/breastfeeding women, and those on unapproved fibrosis drugs.

What is being tested?

The BEACON-IPF study tests bexotegrast (PLN-74809) against a placebo to see if it's safe and effective for treating idiopathic pulmonary fibrosis. Participants are randomly assigned to receive either the drug or a placebo without knowing which one they're getting.

What are the potential side effects?

While specific side effects of bexotegrast aren't listed here, common ones in trials may include gastrointestinal issues, headaches, dizziness, potential liver enzyme changes, and fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 40 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with bexotegrast.

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I have severe liver problems.

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I am on medication for high blood pressure in my lungs.

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I am not taking any experimental drugs for IPF fibrosis.

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I have severe kidney problems or am on dialysis.

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My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Change from baseline in King's Brief Interstitial Lung Disease (K-BILD) questionnaire Total score

Change from baseline in Living with Pulmonary Fibrosis (L-PF) Dyspnoea and Cough Domain score

Change from baseline in absolute FVC (mL) at Week 52

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Placebo

Group II: Bexotegrast (PLN-74809) 320 mg DoseExperimental Treatment1 Intervention

Bexotegrast (PLN-74809) 320 mg Dose - 52 weeks

Group III: Bexotegrast (PLN-74809) 160 mg DoseExperimental Treatment1 Intervention

Bexotegrast (PLN-74809) 160 mg Dose - 52 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PLN-74809

2020

Completed Phase 2

~260

Placebo

1995

Completed Phase 3

~2670

0 / 7Eligibility criteria met

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 is a tyrosine kinase inhibitor that targets multiple growth factor receptors involved in the fibrotic process, thereby slowing the decline in lung function. Pirfenidone works by inhibiting the synthesis of collagen and reducing the production of pro-fibrotic cytokines, which helps to mitigate fibrosis. Bexotegrast, an investigational agent, inhibits integrin αvβ6, a protein that activates transforming growth factor-beta (TGF-β), a key driver of fibrosis. These treatments are important for IPF patients as they can slow disease progression, improve quality of life, and potentially extend survival.