Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT07284459
Eligibility Criteria:
Key Inclusion Criteria:
* Male or female ≥ 40 years of age at the time of Randomization
* A diagnosis of IPF within 7 years prior to Screening, based on the 2018 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT with verification of usual interstitial pneumonia
* Percent predicted (pp) FVC ≥ 40% on Screening spirometry
* Subjects may enter the study whether or not they are receiving background antifibrotic therapy, approved for the treatment of IPF (nintedanib or pirfenidone, but not both concurrently)
Key Exclusion Criteria:
* Those with a history of interstitial lung disease (ILD) other than IPF are not eligible.
* Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible.
* Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible.
* Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible.
Additional inclusion and exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT07284459
Study Brief:
Protocol Section:
NCT07284459