Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulm… (NCT03955146) | Clinical Trial Compass
TerminatedPhase 3
Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Stopped: Study did not meet its primary endpoint.
United States393 participantsStarted 2019-06-18
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 IPF.
Who can participate
Age range40 Years – 85 Years
SexALL
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Inclusion criteria
✓. Diagnosis of IPF as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (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 and corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
✓. Not currently receiving treatment for IPF with an approved therapy (that is, 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.
✕. 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.
✕
What they're measuring
1
DB Period (Main Study Cohort): Change From Baseline in FVC at Week 48
Timeframe: Baseline, Week 48
2
DB Period (Japan Extension Cohort): Change From Baseline in FVC at Week 48
. Sustained improvement in the severity of IPF during the 12 months prior to screening.
✕. History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
✕. Medical conditions (for example, myocardial infarction \[MI\]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.