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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 : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 5, 2020
Last Update Posted Date October 11, 2021
Actual Study Start Date  ICMJE September 30, 2020
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
Time to Disease Progression [ Time Frame: Up to Week 48 ]
Defined as absolute forced vital capacity (FVC) percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
Proportion of subjects with Disease Progression, defined as absolute FVC percent predicted (FVCpp) decline of ≥10% or death, whichever occurs first [ Time Frame: Baseline to Week 52 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2021)
  • Change from Baseline to Week 48 in FVC [ Time Frame: Baseline, Week 48 ]
  • Change from Baseline to Week 48 in Absolute and Relative FVCpp [ Time Frame: Baseline, Week 48 ]
  • Time to Composite of Clinical Outcomes: Respiratory Hospitalization or Death or Absolute FVCpp Decline ≥10%, Whichever Occurs First [ Time Frame: Up to Week 48 ]
  • Time to First Respiratory Hospitalization [ Time Frame: Up to Week 48 ]
  • Change from Baseline to Week 48 in Quantitative Lung Fibrosis (QLF) Volume [ Time Frame: Baseline, Week 48 ]
  • Change from Baseline to Week 48 in St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline, Week 48 ]
    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for 3 domains: Symptoms, Activity and Impacts. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
  • Change from Baseline to Week 48 in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline, Week 48 ]
  • Change from Baseline to Week 48 in Leicester Cough Questionnaire (LCQ) [ Time Frame: Baseline, Week 48 ]
    The LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7-point Likert response scale (ranging from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on 3 main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score.
  • Time to All-Cause Mortality [ Time Frame: Up to Week 48 ]
  • Time to First Acute IPF Exacerbation [ Time Frame: Up to Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • Change in FVC (L) [ Time Frame: Baseline to Week 52 ]
  • Change in FVCpp (absolute and relative) [ Time Frame: Baseline to Week 52 ]
  • 4.Composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first [ Time Frame: Baseline to Week 52 ]
  • Respiratory hospitalizations during study [ Time Frame: Baseline to Week 52 ]
  • Change in Quantitative Lung Fibrosis (QLF) volume [ Time Frame: Baseline to Week 52 ]
  • Change in St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Baseline to Week 48 ]
    The SGRQ is a 50-item questionnaire developed to measure health status (quality of life). Scores are calculated for three domains: Symptoms, Activity and Impacts. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status.
  • Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline to Week 48 ]
  • Change in Leicester Cough Questionnaire (LCQ) [ Time Frame: Baseline to Week 48 ]
    The LCQ is a self-reporting quality of life measure of chronic cough. It consists of 19 items with a 7 point likert response scale (range from 1 to 7). Each item is developed to assess symptoms during cough and impact of cough on three main domains: physical, psychological and social. Scores are calculated as a mean of each domain and the total score is calculated by adding every domain score.
  • All-cause mortality during study [ Time Frame: Baseline to Week 52 ]
  • Acute IPF exacerbations during study [ Time Frame: Baseline to Week 52 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)
Official Title  ICMJE Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
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 participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: Pamrevlumab
    Sterile solution for injection
    Other Name: FG-3019
  • Drug: Placebo
    Sterile solution for injection
Study Arms  ICMJE
  • Experimental: Pamrevlumab

    Treatment phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks, for a total of 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

    Intervention: Drug: Pamrevlumab
  • Experimental: Placebo
    Pamrevlumab-matching placebo administered by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2020)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  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.

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.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tracy Ganske (415) 978-1427 tganske@fibrogen.com
Listed Location Countries  ICMJE Brazil,   Colombia,   Czechia,   Denmark,   Dominican Republic,   France,   Georgia,   Germany,   Hungary,   Italy,   Lebanon,   Mexico,   Netherlands,   Peru,   Poland,   Serbia,   Spain,   Ukraine,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04419558
Other Study ID Numbers  ICMJE FGCL-3019-095
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FibroGen
Study Sponsor  ICMJE FibroGen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account FibroGen
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP