Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955146
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
FibroGen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

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

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 : June 27, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Pamrevlumab Drug: Pamrevlumab
Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
Other Name: FG-3019
Experimental: Placebo Drug: Placebo
Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in FVC (L) [ Time Frame: Baseline to Week 48 ]

Secondary Outcome Measures :
  1. Time to disease progression defined as absolute FVCpp decline of ≥10% or death, whichever occurs first. [ Time Frame: Baseline to Week 48 ]
  2. Change in FVCpp (absolute and relative) [ Time Frame: Baseline to Week 48 ]
  3. Time to composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first [ Time Frame: Baseline to Week 48 ]
  4. Time to first respiratory hospitalizations during study [ Time Frame: Baseline to Week 48 ]
  5. Change in Quantitative Lung Fibrosis (QLF) volume [ Time Frame: Baseline to Week 48 ]
  6. 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.

  7. Change in University of California San Diego - Shortness of Breath Questionnaire (UCSD-SOBQ) [ Time Frame: Baseline to Week 48 ]
    The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness associated with activities of daily living, on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome).

  8. 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.

  9. Time to all-cause mortality during study [ Time Frame: Baseline to Week 48 ]
  10. Time to first acute IPF exacerbations during study [ Time Frame: Baseline to Week 48 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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.

Key Exclusion Criteria:

  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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03955146


Contacts
Layout table for location contacts
Contact: Gustavo Lorente 650-273-2264 Zephyrus@Fibrogen.com

Locations
Show Show 74 study locations
Sponsors and Collaborators
FibroGen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT03955146    
Other Study ID Numbers: FGCL-3019-091
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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:
Layout table for MeSH terms
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial