Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary F… (NCT04419558) | Clinical Trial Compass
TerminatedPhase 3
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Stopped: Sponsor Decision
United States372 participantsStarted 2020-09-30
Plain-language summary
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.
✓. High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to \<50% parenchymal fibrosis (reticulation) and \<25% honeycombing.
✓. FVCpp value \>45% and \<95% at Screening and Day 1 (prior to randomization).
✓. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.
✓. Not currently receiving treatment for IPF with an approved therapy for IPF (such as, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.
Exclusion criteria
✕. Previous exposure to pamrevlumab.
✕. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.
✕. Female participants who are pregnant or nursing.
✕. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
✕. Interstitial lung disease other than IPF.
✕. Sustained improvement in the severity of IPF during the 12 months prior to screening.
✕. Other types of respiratory diseases that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study, including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
✕. Certain medical conditions, that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study (such as, myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or cancers).