Education and Training
Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Pamrevlumab
- drug: Placebo
Eligibility
Key Inclusion Criteria:
1. 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.
2. High-resolution computed tomography (HRCT) scan at screening, with ≥10% to <50%
parenchymal fibrosis (reticulation) and <25% honeycombing.
3. FVCpp value >45% and <95% at screening and Day 1 (prior to randomization).
4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted and
corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
5. 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.
Key Exclusion Criteria:
1. Previous exposure to pamrevlumab.
2. Evidence of significant obstructive lung disease.
3. Female participants who are pregnant or nursing.
4. Smoking within 3 months of screening and/or unwilling to avoid smoking throughout the
study.
5. Interstitial lung disease other than IPF.
6. Sustained improvement in the severity of IPF during the 12 months prior to screening.
7. History of other types of respiratory diseases including diseases or disorders of the
airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
8. 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.
9. Acute IPF exacerbation during screening or randomization.
10. Use of any investigational drugs or unapproved therapies, or participation in any
clinical trial with an investigational new drug within 30 days prior to screening. Or
use of approved IPF therapies (that is, pirfenidone or nintedanib) within 1 week prior
to screening.
11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine
monoclonal antibodies, or to any component of the excipient.
Ages Eligible for Study
40 Years - 85 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting