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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 : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
FibroGen

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) over a 52 week period.

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

Screening period: Up to 6 weeks Treatment period: 48 weeks Follow-up period/final assessment: 4 weeks (Week 52 [+7 Days])

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.

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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)
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


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




Primary Outcome Measures :
  1. Change in FVC (L) [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Proportion of subjects with Disease Progression, defined as absolute FVCpp decline of ≥10% or death, whichever occurs first. [ Time Frame: Baseline to Week 52 ]
  2. Change in FVCpp (absolute and relative) [ Time Frame: Baseline to Week 52 ]
  3. Composite of clinical outcomes: respiratory hospitalization or death or absolute FVCpp decline ≥10%, whichever occurs first [ Time Frame: Baseline to Week 52 ]
  4. Respiratory hospitalizations during study [ Time Frame: Baseline to Week 52 ]
  5. Change in Quantitative Lung Fibrosis (QLF) volume [ Time Frame: Baseline to Week 52 ]
  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. All-cause mortality during study [ Time Frame: Baseline to Week 52 ]
  10. Acute IPF exacerbations during study [ Time Frame: Baseline to Week 52 ]


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.


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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 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 ≥50% and ≤80%.
  4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥30% and ≤90%.
  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.

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
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Contact: Gustavo Lorente 650-273-2264 Zephyrus@Fibrogen.com

Locations
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United States, Arizona
Research Center Recruiting
Phoenix, Arizona, United States, 85006
United States, Colorado
Research Center Recruiting
Denver, Colorado, United States, 80206
United States, Florida
Research Center Recruiting
Clearwater, Florida, United States, 33765
Research Center Recruiting
Gainesville, Florida, United States, 32610
Research Center Recruiting
Jacksonville, Florida, United States, 32209
Research Center Recruiting
Kissimmee, Florida, United States, 34741
United States, Georgia
Research Center Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Research Center Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
Research Center Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Research Center Recruiting
Louisville, Kentucky, United States, 40202
United States, Missouri
Research Center Recruiting
Chesterfield, Missouri, United States, 63017
United States, North Carolina
Research Center Recruiting
Greensboro, North Carolina, United States, 27403
United States, Ohio
Research Center Recruiting
Cincinnati, Ohio, United States, 45267
United States, Oregon
Research Center Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19107
Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Research Center Recruiting
Charleston, South Carolina, United States, 29406
United States, Tennessee
Research Center Not yet recruiting
Hendersonville, Tennessee, United States, 37075
United States, Texas
Research Center Recruiting
Dallas, Texas, United States, 75390
Research Center Recruiting
The Woodlands, Texas, United States, 77380
Hong Kong
Research Center Recruiting
Central, Hong Kong
Taiwan
Research Center Recruiting
Douliu, Yunlin County, Taiwan, 640
Research Center Recruiting
Taipei city, Zhongzheng District, Taiwan, 10002
Sponsors and Collaborators
FibroGen
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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: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial