Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    340
  • sponsor
    FibroGen
Updated on 18 October 2021
carbon monoxide
nintedanib
idiopathic pulmonary fibrosis
pirfenidone
pamrevlumab
diffusion capacity of the lung for carbon monoxide

Summary

This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/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.

Description

The intent of this study is to evaluate the efficacy and safety profile of pamrevlumab as monotherapy in participants with IPF who were previously treated with an approved therapy but who discontinued that therapy (possible reasons for discontinuation of approved therapy could include, but are not limited to, intolerance or disease progression), unless neither treatment is available in the host country.

During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment. However, since participants either tried and stopped treatment with an approved IPF therapy, or have no such treatment available, it is not expected that many participants will resume treatment with an approved IPF therapy during this study.

Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.

Details
Condition Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, usual interstitial pneumonia
Treatment Placebo, Pamrevlumab
Clinical Study IdentifierNCT04419558
SponsorFibroGen
Last Modified on18 October 2021

Eligibility

Yes No Not Sure

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
Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted 25% and 90%
Previously treated with an approved IPF therapy (such as, pirfenidone or nintedanib) but discontinued at least 1 week prior to screening, unless neither treatment is available in the host country

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
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
Recent use of any investigational drugs or unapproved therapies, or participation in any clinical trial
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient
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