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Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis


Brief 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 subjects with Idiopathic Pulmonary Fibrosis

Primary Purpose
Study Type
Phase III


Healthy Volunteers
Minimum Age
40 Years
Maximum Age
85 Years

Key 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.

Key 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.

Join this Trial

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Study Stats
Protocol No.
Pulmonary Disease
Eileen Callahan
  • UCLA Westwood
For Providers
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