What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib and pirfenidone. Nintedanib is associated with side effects such as diarrhea, nausea, and liver enzyme elevations. Pirfenidone commonly causes nausea, rash, and photosensitivity. Both medications aim to slow disease progression but can have significant adverse effects that may require dose adjustments or discontinuation.

What prior FDA approvals exist?

The FDA has approved two primary antifibrotic medications for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple growth factor receptors involved in fibrotic processes, while pirfenidone has antifibrotic and anti-inflammatory properties. These drugs slow disease progression and reduce the frequency of acute exacerbations, making them relevant to the study of DWN12088, which likely targets similar pathways in IPF progression.

What other types of research exist?

Promising novel alternatives to DWN12088 for IPF patients include: 1) GSK2126458, a PI3 kinase/mTOR inhibitor, which targets the PI3K pathway involved in fibrotic processes. 2) GSK3008348, an inhaled integrin αvβ6 inhibitor, which is being developed to directly target lung tissue. 3) NSC668036, which inhibits the Wnt/β-catenin signaling pathway at the Dvl level, potentially reducing fibrogenesis. 4) Pamrevlumab, an anti-connective tissue growth factor therapy, which has shown efficacy in slowing disease progression in clinical trials.

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DWN12088 for Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

Led By JW Song

Research Sponsored by Daewoong Pharmaceutical Co. LTD.

Eligibility Criteria Checklist

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

Must have

Male or female patients aged ≥40 years based on the date of the written informed consent form

Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines

Must not have

Female patients who are pregnant or nursing

Acute IPF exacerbation within 6 months prior to screening and/or during the screening period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 through week 24

Summary

This trial is testing a new drug called DWN12088 to see if it can help people with Idiopathic Pulmonary Fibrosis, a serious lung disease. The study will check if the drug is safe and effective. The exact way the drug works is not detailed, but it aims to improve lung function or slow down the disease.

Who is the study for?

This trial is for adults aged 40 or older with Idiopathic Pulmonary Fibrosis (IPF), having specific lung function levels. They must be stable, not have used experimental IPF drugs recently, and non-smokers for at least 3 months. Pregnant or nursing women and those with recent acute IPF exacerbations cannot participate.

What is being tested?

The study tests DWN12088's safety and effectiveness against a placebo in managing IPF. Participants are randomly assigned to receive either the drug or a placebo without knowing which one they get, ensuring the results are unbiased.

What are the potential side effects?

While specific side effects of DWN12088 aren't listed here, common ones in trials like this may include gastrointestinal issues, skin reactions, fatigue, headache, coughing or worsening of respiratory symptoms.

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.

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I have been diagnosed with IPF according to specific lung association guidelines.

Exclusion Criteria

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

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I am not pregnant or nursing.

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I have had a sudden worsening of my lung condition in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 through week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 through week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 through week 24 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidents of treatment-emergent adverse events

Rate of decline of FVC

Secondary study objectives

Diffusing capacity of lung for carbon monoxide (DLCO) corrected for Hgb

Functional exercise capacity, assessed by the 6-minute walk test (6MWT) distance

Quantitative high-resolution computed tomography

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DWN12088 Xmg Tablet (BID)Experimental Treatment1 Intervention

PRS inhibitor

Group II: Placebo 0mg Tablet (BID)Placebo Group1 Intervention

Placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DWN12088

2021

Completed Phase 1

~80

0 / 4Eligibility 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) are nintedanib and pirfenidone, both of which aim to slow disease progression by targeting fibrotic pathways. Nintedanib inhibits tyrosine kinases involved in the signaling of growth factors like VEGF, FGF, and PDGF, which are essential for fibroblast activation and proliferation. Pirfenidone reduces the synthesis of pro-fibrotic cytokines such as TGF-β and TNF-α. These mechanisms are crucial for IPF patients as they help mitigate the fibrotic activity in the lungs, slowing the decline in lung function and improving quality of life. DWN12088, under investigation, likely targets similar fibrotic pathways, potentially offering another therapeutic option for IPF management.

Epithelial-Mesenchymal Transition: A Major Pathogenic Driver in Idiopathic Pulmonary Fibrosis?Escape from the matrix: multiple mechanisms for fibroblast activation in pulmonary fibrosis.