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New treatment option for Idiopathic Pulmonary Fibrosis (IPF)
Official title Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT05975983
What this study is testing
What is INS018_055?
INS018_055 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for idiopathic pulmonary fibrosis (ipf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this revised Phase IIa study is to demonstrate safety of INS018\_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG...
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted normal
You likely can't join if
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
See the full eligibility criteria
- 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
- In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted normal
- DLCO corrected for Hgb ≥25% and \<80% predicted normal
- Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Celebration, Florida, United States
- Orlando, Florida, United States
- Winston-Salem, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Columbia, South Carolina, United States
- Dallas, Texas, United States
- McKinney, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Scottsdale, Arizona, United States; Los Angeles, California, United States; Celebration, Florida, United States; Orlando, Florida, United States; Winston-Salem, North Carolina, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.