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

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ClinicalTrials.gov Identifier: NCT04419558
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : March 10, 2023
Sponsor:
Information provided by (Responsible Party):
FibroGen

Study Description
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Brief Summary:
This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Pamrevlumab Drug: Placebo Phase 3

Detailed Description:

The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants 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
  • Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks

NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.

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.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: During the Open-label extension phase, all participants will receive pamrevlumab in an open-label manner. No unblinding of participant's treatment assignment in the treatment phase (main study) will occur for purposes of open-label extension participation.
Primary Purpose: Treatment
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)
Actual Study Start Date : September 30, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pamrevlumab

Treatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks.

Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks

 Drug: Pamrevlumab
Sterile solution for injection
Other Name: FG-3019
Experimental: Placebo
Pamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
 Drug: Placebo
Sterile solution for injection


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Forced Vital Capacity (FVC) at Week 48 [ Time Frame: Baseline, Week 48 ]

Secondary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: Up to Week 48 ]
    Defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first

  2. Change from Baseline to Week 48 in Quantitative Lung Fibrosis (QLF) Volume [ Time Frame: Baseline, Week 48 ]
  3. Time to Any Component of the Clinical Composite Endpoint, Whichever Occurs First: Acute IPF Exacerbation, Respiratory Hospitalization, or Death [ Time Frame: Up to Week 48 ]
  4. Time to First Acute IPF Exacerbation [ Time Frame: Up to Week 48 ]
  5. Time to All-Cause Mortality [ Time Frame: Up to Week 48 ]
  6. Time to First Respiratory Hospitalization [ Time Frame: Up to Week 48 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  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 (prior to randomization).
  4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.
  5. Not currently receiving treatment for IPF with an approved therapy for IPF (such as, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.

Key Exclusion Criteria:

  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 during the 12 months prior to screening.
  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. Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 week prior to screening.
  11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419558


Contacts
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Contact: Tracy Ganske (415) 978-1427 zephyrus@fibrogen.com

Locations
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Sponsors and Collaborators
FibroGen
More Information
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Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT04419558    
Other Study ID Numbers: FGCL-3019-095
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: March 10, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by FibroGen:
Idiopathic Pulmonary Fibrosis
IPF
Idiopathic Interstitial Pneumonia
Interstitial Lung Disease
Lung Fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
 Pathologic Processes
Lung Diseases
Respiratory Tract Diseases