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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 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

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.

Find a Location

Who is running the clinical trial?

InSilico Medicine Hong Kong LimitedLead Sponsor
7 Previous Clinical Trials
824 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
149 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

INS018_055 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05975983 — Phase 2
Idiopathic Pulmonary Fibrosis Research Study Groups: INS018_055, Placebo
Idiopathic Pulmonary Fibrosis Clinical Trial 2023: INS018_055 Highlights & Side Effects. Trial Name: NCT05975983 — Phase 2
INS018_055 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975983 — Phase 2
~40 spots leftby Feb 2026