What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) are nintedanib and pirfenidone, both of which are antifibrotic agents. Nintedanib is frequently associated with gastrointestinal side effects, particularly diarrhea, which can lead to treatment discontinuation. Other side effects include anorexia and elevated liver enzymes. Pirfenidone commonly causes gastrointestinal issues such as nausea and dyspepsia, as well as skin-related side effects like rash and photosensitivity. Both medications have been shown to slow disease progression but do not cure IPF.

What prior FDA approvals exist?

The FDA has approved two primary anti-fibrotic drugs for the treatment of Idiopathic Pulmonary Fibrosis (IPF): pirfenidone and nintedanib. Pirfenidone is an oral medication that has anti-fibrotic and anti-inflammatory properties, shown to slow the decline in lung function. Nintedanib, a tyrosine kinase inhibitor, also slows disease progression by targeting multiple pathways involved in fibrosis. Both drugs have demonstrated efficacy in reducing the rate of decline in forced vital capacity (FVC) in patients with IPF.

What other types of research exist?

Promising alternatives to INS018_055 for IPF treatment include pirfenidone and nintedanib. Pirfenidone has shown to slow disease progression and reduce mortality in multiple phase 3 trials. Nintedanib, a tyrosine kinase inhibitor, has demonstrated efficacy in slowing the decline in lung function and is effective in both early and advanced stages of IPF. Both agents are well-studied and have established safety profiles.

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INS018_055 for Idiopathic Pulmonary Fibrosis

Phase 2

Recruiting

Research Sponsored by InSilico Medicine Hong Kong Limited

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

Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator

Female patients who are pregnant or nursing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new oral medication, INS018_055, in adults with Idiopathic Pulmonary Fibrosis (IPF). It aims to see if the medication is safe and well-tolerated over a few months.

Who is the study for?

Adults over 40 with Idiopathic Pulmonary Fibrosis (IPF) can join this trial. They must have a certain level of lung function and be in stable condition, as confirmed by medical tests. If they're taking specific IPF medications, these should be unchanged for at least 8 weeks before the study starts. Pregnant or nursing women, smokers who haven't quit for 6 months, and those with recent severe IPF flare-ups or abnormal heart readings cannot participate.

What is being tested?

The trial is testing INS018_055 taken orally against a placebo to see if it's safe and tolerable when given for up to 12 weeks to adults with IPF. The main goal is to compare side effects between the new drug and the placebo.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions from taking INS018_055 compared to those just receiving a placebo pill without active medication.

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 have had a sudden worsening of my lung condition within the last 4 months.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: INS018_055Experimental Treatment1 Intervention

Group 1: INS018_055 once daily up to 12 weeks, low dose Group 2: INS018_055 twice daily up to 12 weeks, low dose Group 3: INS018_055 once daily up to 12 weeks, high dose

Group II: PlaceboPlacebo Group1 Intervention

Group 4: Placebo once or twice daily up to 12 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

INS018_055

2022

Completed Phase 2

~150

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) include nintedanib and pirfenidone, both of which are antifibrotic agents. Nintedanib works by inhibiting multiple tyrosine kinases involved in the pathways of fibrosis, such as VEGF, FGF, and PDGF. Pirfenidone reduces fibrosis by inhibiting the production of TGF-β and other fibrogenic mediators. These mechanisms are crucial as they help to slow the progression of lung fibrosis, thereby preserving lung function and improving the quality of life for IPF patients. New potential treatments like INS018_055, which may have anti-fibrotic or anti-inflammatory properties, are being studied to provide additional therapeutic options.

Pharmacological treatment of idiopathic pulmonary fibrosis - preclinical and clinical studies of pirfenidone, nintedanib, and N-acetylcysteine.TGF-beta-induced EMT: mechanisms and implications for fibrotic lung disease.