Summary

Eligibility
for people ages 40-85 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Golden

Description

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.

Official Title

Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Details

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.

Keywords

Idiopathic Pulmonary Fibrosis IPF Idiopathic Interstitial Pneumonia Interstitial Lung Disease Lung Fibrosis Pulmonary Fibrosis Fibrosis Pamrevlumab

Eligibility

You can join if…

Open to people ages 40-85

  1. 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.
  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.
  4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.
  5. 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.

You CAN'T join if...

  1. Previous exposure to pamrevlumab.
  2. Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.
  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.
  7. 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.
  8. 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).
  9. Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.
  10. . Recent use of any investigational drugs or unapproved therapies, or participation in any clinical trial.
  11. . History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.

Locations

  • UC San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • National Jewish Health not yet accepting patients
    Denver Colorado 80206 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
FibroGen
ID
NCT04419558
Phase
Phase 3
Study Type
Interventional
Last Updated