Summary

Eligibility
for people ages 40-85 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Gordon Yung
Photo of Gordon Yung
Gordon Yung

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 subjects with Idiopathic Pulmonary Fibrosis

Official Title

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

Details

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab 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. Examples of reasons subjects may not be treated with approved IPF therapies include but are not limited to: - Intolerant or not responsive to approved IPF therapies - Ineligible to receive these therapies - Subject voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks NOTE: No subject should discontinue an approved IPF therapy for the purpose of enrolling in this study. Approximately 340 eligible subjects will be randomized at a 1:1 ratio to Arm A or Arm B, respectively: Arm A: pamrevlumab, 30 mg/kg IV, Day 1 and every 3 weeks thereafter Arm B: Matching placebo IV, Day 1 and every 3 weeks thereafter The study consists of the following study periods: - Main (double blind, placebo-controlled) phase: - Screening period: Up to 6 weeks - Treatment period: 48 weeks - Optional, open label extension (OLE) phase of pamrevlumab: o Access to pamrevlumab will be available until the last subject completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first. - Follow-up period/final safety assessments: - 28 days after last dose - 60 days after last dose: follow-up phone call, for a final safety assessment During the treatment period, co-administration of an approved IPF therapy (i.e., pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment. Subjects who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments. Subjects who complete the study will be eligible for an open-label, extension with pamrevlumab.

Keywords

Idiopathic Pulmonary Fibrosis 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 ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation.
  2. HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing.
  3. FVCpp value >45% and <95%
  4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90% at screening (determined locally).
  5. 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.

You CAN'T join if...

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

Locations

  • University of California San Diego not yet accepting patients
    San Diego California 92103 United States
  • Loma Linda University Health accepting new patients
    Loma Linda California 92354 United States

Lead Scientist at UCSD

  • Gordon Yung
    Clinical Professor, Medicine. Authored (or co-authored) 22 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
FibroGen
ID
NCT03955146
Phase
Phase 3
Study Type
Interventional
Last Updated