Atezolizumab for Idiopathic Pulmonary Fibrosis (NCT05515627) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Atezolizumab for Idiopathic Pulmonary Fibrosis
United States24 participantsStarted 2023-02-15
Plain-language summary
The purpose of this study is to determine the safety and preliminary efficacy of atezolizumab, an immune checkpoint inhibitor approved for the treatment of various cancers, in patients with idiopathic pulmonary fibrosis (IPF).
Who can participate
Age range50 Years – 80 Years
SexALL
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Inclusion Criteria:
* Males or females ≥50 years of age
* Confident diagnosis of IPF per 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline on Diagnosis of IPF1
* Subjects must have a high-resolution computed tomography (HRCT) completed in the 6 months prior to informed consent
* Subjects must have HRCT pattern of definite or probable UIP
* Subjects without HRCT pattern of definite or probable UIP must have surgical lung biopsy showing histopathology consistent with UIP
* Extent of fibrotic changes must be greater than the extent of emphysema on HRCT
* Review of all available IPF treatment options with the potential subject prior to consent for participation in the study
* Negative hepatitis B surface antigen (HBsAg) test at screening
* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAB test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive total HBcAb test.
* Negative hepatitis C antibody
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs, as defined below:
Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab. Women must refrain from donating eggs during this same period.
A woman i…