Status:
TERMINATED
Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Lead Sponsor:
FibroGen
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief 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 participa...
Detailed Description
The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nin...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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).
- Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.
- 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 (such as, pirfenidone or nintedanib) within 1 week prior to screening.
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2023
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT04419558
Start Date
September 30 2020
End Date
September 4 2023
Last Update
August 12 2024
Active Locations (157)
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1
UAB Lung Health Center
Birmingham, Alabama, United States, 35294
2
UC San Francisco
San Francisco, California, United States, 94143
3
National Jewish Health
Denver, Colorado, United States, 80206
4
Yale University
New Haven, Connecticut, United States, 06520