Back to resultsSafety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis (FGCL-3019-049)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FG-3019
FG-3019
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis
Eligibility Criteria
Main Inclusion Criteria:
- Age 35 to 80 years, inclusive.
- Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).
- History of IPF of 5 years duration or less.
- Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the last 18 months for Cohort 2 before screening.
- Women of childbearing potential, and men, must be willing to use a medically acceptable method of contraception during the trial and 3 months after the last dose of study drug.
Main Exclusion Criteria:
- Women who are pregnant or nursing.
- History of any other types of lung or heart disease and any other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study.
- Clinically important abnormal laboratory tests.
- Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.
- Acute exacerbation of IPF within 3 months of the first screening visit.
- Use of certain medications within 4 weeks of the first screening visit.
- Receipt of an investigational drug within 6 weeks of the first screening visit.
- History of cancer of any type in the 5 years preceding the first screening visit, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
- Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.
- Planned elective surgery during the study including 4 weeks following the final dose of study drug.
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
- Inability to cooperate with study personnel or history of non-compliance to a medical regimen.
- Previous treatment with FG-3019.
Sites / Locations
- University of Alabama at Birmingham Hospital
- Arizona Pulmonary Specialists, LTD
- Yale University
- Central Florida Pulmonary Group, PA
- Tampa General Hospital
- Emory University
- Via Christi Hospitals Wichita, Inc.
- University of Louisville
- St. Luke's Hospital
- Rutgers-Robert Wood Johnson Medical School
- Mount Sinai
- The Ohio State University
- Vanderbilt University
- University of Texas Southwestern Medical Center
- University of Utah - Lung Health Research
- Vermont Lung Center
- Inova Fairfax Hospital
- University of Wisconsin School of Medicine & Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1/1-EX
Cohort 2/2-EX
Arm Description
Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
Outcomes
Primary Outcome Measures
To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years.
Secondary Outcome Measures
To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF.
To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF.
To evaluate the effect of FG-3019 on dyspnea in subjects with IPF.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01262001
Brief Title
Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
Acronym
FGCL-3019-049
Official Title
A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 26, 2014 (Actual)
Study Completion Date
June 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.
Detailed Description
Major Changes: FGCL-3019-049 Protocol Amendment 3 offers long-term extension of treatment with FG-3019 to eligible Cohort 1-EX (approximately 14 subjects) and Cohort 2 (approximately 28 subjects) subjects who complete the Week 48-EX and Week 48 assessments described in Protocol Amendment 2, respectively. A subject is eligible for long-term extension of treatment if the investigator, after discussion with the Fibrogen Medical Monitor, believes that the subject would benefit from continued treatment with FG-3019.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
FG-3019 administered at dose of 15 mg/kg (Cohort 1 ) by IV infusion every 3 weeks for 45 weeks in the target population.(first treatment year and first extended treatment year) and every 3 weeks thereafter for three additional extended treatment years.
Masking
None (Open Label)
Masking Description
FG-3019 administered at dose of 30 mg/kg (Cohort 2 ) by IV infusion every 3 weeks for 45 weeks in the target population.(first treatment year and first extended treatment year) and every 3 weeks thereafter for three additional extended treatment years.
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1/1-EX
Arm Type
Experimental
Arm Description
Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
Arm Title
Cohort 2/2-EX
Arm Type
Experimental
Arm Description
Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
Intervention Type
Drug
Intervention Name(s)
FG-3019
Other Intervention Name(s)
Pamrevlumab
Intervention Description
Cohort 1 and Cohort 1-EX: 15 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).
Intervention Type
Drug
Intervention Name(s)
FG-3019
Other Intervention Name(s)
Pamrevlumab
Intervention Description
Cohort 2 and Cohort 2-EX: 30 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).
Primary Outcome Measure Information:
Title
To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years.
Time Frame
Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks
Secondary Outcome Measure Information:
Title
To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF.
Time Frame
Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks
Title
To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF.
Time Frame
Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks
Title
To evaluate the effect of FG-3019 on dyspnea in subjects with IPF.
Time Frame
Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Age 35 to 80 years, inclusive.
Clinical diagnosis of IPF by high resolution computed tomography (HRCT) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity).
History of IPF of 5 years duration or less.
Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the last 18 months for Cohort 2 before screening.
Women of childbearing potential, and men, must be willing to use a medically acceptable method of contraception during the trial and 3 months after the last dose of study drug.
Main Exclusion Criteria:
Women who are pregnant or nursing.
History of any other types of lung or heart disease and any other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study.
Clinically important abnormal laboratory tests.
Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.
Acute exacerbation of IPF within 3 months of the first screening visit.
Use of certain medications within 4 weeks of the first screening visit.
Receipt of an investigational drug within 6 weeks of the first screening visit.
History of cancer of any type in the 5 years preceding the first screening visit, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer.
Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.
Planned elective surgery during the study including 4 weeks following the final dose of study drug.
History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
Inability to cooperate with study personnel or history of non-compliance to a medical regimen.
Previous treatment with FG-3019.
Facility Information:
Facility Name
University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Pulmonary Specialists, LTD
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Central Florida Pulmonary Group, PA
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Via Christi Hospitals Wichita, Inc.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
St. Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Rutgers-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Utah - Lung Health Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Vermont Lung Center
City
Colchester
State/Province
Vermont
ZIP/Postal Code
05446
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
University of Wisconsin School of Medicine & Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26965296
Citation
Raghu G, Scholand MB, de Andrade J, Lancaster L, Mageto Y, Goldin J, Brown KK, Flaherty KR, Wencel M, Wanger J, Neff T, Valone F, Stauffer J, Porter S. FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in idiopathic pulmonary fibrosis. Eur Respir J. 2016 May;47(5):1481-91. doi: 10.1183/13993003.01030-2015. Epub 2016 Mar 10.
Results Reference
derived
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Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
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