Idiopathic Pulmonary Fibrosis study: INS018_055
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?
This is an investigational oral tablet being studied as a potential treatment for Idiopathic Pulmonary Fibrosis (IPF). It is designed to block a specific protein called TNIK in the body.
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
- This study aims to check if the medicine is safe to take over a 12-week period.
- Who it's for
- The study is looking for adults who have been diagnosed with idiopathic pulmonary fibrosis.
- What's involved
- Participants will take the study medicine by mouth and undergo safety checks.
- Time commitment
- The study lasts 12 weeks and requires visits to monitor safety.
- 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...
- FVC ≥40% predicted normal
- DLCO corrected for Hgb ≥25% and \<80% 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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at 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 locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.