Your session is about to expire
← Back to Search
Other
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following the first dose on day 1 (visit 2) and the last dose during week 12 (visit 6, end of treatment (eot))
Awards & highlights
Study Summary
This trial will learn whether a drug called INS018_055 is safe & effective for adult IPF patients.
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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following the first dose on day 1 (visit 2) and the last dose during week 12 (visit 6, end of treatment (eot))
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following the first dose on day 1 (visit 2) and the last dose during week 12 (visit 6, end of treatment (eot))
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of patients who have at least 1 treatment-emergent adverse event (TEAE)
Secondary outcome measures
Absolute and relative change in FVC % predicted
Accumulation ratio (Rac) for Cmax and AUC of INS018_055 and metabolites (INS018_063 and INS018_095)
Apparent clearance (CL/F) of INS018_055 and metabolites (INS018_063 and INS018_095)
+16 moreTrial 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 1
~80
Find a Location
Who is running the clinical trial?
InSilico Medicine Hong Kong LimitedLead Sponsor
4 Previous Clinical Trials
290 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
148 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the regulatory body accepted INS018_055 to be utilized in clinical practice?
"Taking into account its Phase 2 status, which implies there is some evidence of safety but none regarding efficacy, the Power team assigned INS018_055 a score of 2."
Answered by AI
Are there any vacancies left in the experiment for participants?
"The clinicaltrials.gov page confirms that, although this research was initially posted on October 1st 2023 and last modified on July 27th 2023, it is no longer actively recruiting patients. Nonetheless, there are still 418 other medical studies in need of participants at the present moment."
Answered by AI
What is the geographic scope of this trial's management?
"Nine recruiting locations have been identified for this trial, including the Florida Lung Asthma and Sleep Specialist in Celebration, Southeastern Research Center in Winston-Salem, and University of Oklahoma Health Sciences Center (OUHSC) in Oklahoma City. Six other medical sites are also partaking in recruitment efforts."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger