Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis

The purpose of this study is to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with idiopathic pulmonary fibrosis (IPF). Subjects who are not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) may be eligible for screening. No subject should discontinue an approved IPF therapy for the purpose of enrolling in this study.

  • Study Sponsor: FibroGen

  • Start Date: June 2019

  • Estimated Primary Completion Date: December 2021

  • Phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of pamrevlumab in subjects with idiopathic pulmonary fibrosis (IPF)

Inclusion Criteria:

  • Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation
  • HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing
  • FVCpp value >45% and <95%
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90% at screening (determined locally)
  • Not currently receiving treatment for IPF with an approved therapy (i.e., pirfenidone or nintedanib) for any reason, including prior intolerance to an approved IPF therapy

Exclusion Criteria:

  • Previous exposure to pamrevlumab
  • Evidence of significant obstructive lung disease
  • Female subjects 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 including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall
  • Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart failure or pulmonary hypertension, or cancers
  • Acute IPF exacerbation during Screening or Randomization
  • Recent use of any investigational drugs or unapproved therapies, or approved or participation in any clinical trial
  • History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies

Participating Clinics at Partner ILD Centers