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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 belowSelect...
I am 40 years old or older.
Select...
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:Select...
I have had a sudden worsening of my lung condition within the last 4 months.
Select...
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
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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a sudden worsening of my lung condition within the last 4 months.My health is stable enough for me to join a study, based on recent medical checks.Your heart's electrical activity on an ECG is not normal.Your lung function test shows a specific ratio of airflow that is above a certain number.I am not pregnant or nursing.I am 40 years old or older.Your lung function is at least 40% of what is expected for someone your age and size.Your lung function test (DLCO corrected for Hgb) is between 25% and 80% of what is expected for someone your age and size.I have been diagnosed with IPF according to specific lung association guidelines.I have been on a stable dose of pirfenidone or nintedanib for at least 8 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: INS018_055
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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