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:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT05349760
Eligibility Criteria:
Inclusion Criteria:
1. Subjects ≥40 years old.
2. History of confirmed diagnosis of IPF
3. Chest HRCT at Screening
4. Subjects who are either:
* Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or
* Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)
5. Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
6. Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70
7. Has adequate hematologic, hepatic, and renal function
Exclusion Criteria:
1. Prior investigational drug use within 30 days or 5 half-lives
2. Presence of emphysema exceeding the extent of fibrosis
3. Active or anticipated need for lung transplant
4. Treatment with prednisone
5. Active cancer
6. Active or chronic infection with HCV, HBV, or HIV
7. Known active tuberculosis
8. History of or current immunosuppressive condition
9. IPF exacerbation within 12 weeks
10. Lower respiratory-tract infection requiring antibiotic therapy
11. Smoking
12. Other forms of interstitial lung disease
13. History of lung volume reduction surgery or lung transplant
14. Contraindications for forced expiratory maneuvers during spirometry
15. Unstable cardiac or pulmonary disease (other than IPF)
16. Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
17. History of drug or alcohol abuse -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05349760
Study Brief:
Protocol Section:
NCT05349760