Clincosm LogoSign in Get a demo

FGCL-3019-049: Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

Sponsor
FibroGen (Industry)
Overall Status
Completed
CT.gov ID
NCT01262001
Collaborator
(none)
90
Enrollment
18
Locations
2
Arms
75.7
Duration (Months)
5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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.
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Jun 26, 2014
Actual Study Completion Date :
Jun 21, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1/1-EX

Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression

Drug: FG-3019
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).
Other Names:
  • Pamrevlumab

    		•
    Experimental: Cohort 2/2-EX

    Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression

    Drug: FG-3019
    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).
    Other Names:
  • Pamrevlumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [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 Measures

    1. To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF. [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]

    2. To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF. [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]

    3. To evaluate the effect of FG-3019 on dyspnea in subjects with IPF. [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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Main Inclusion Criteria:

    1. Age 35 to 80 years, inclusive.

    2. 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).

    3. History of IPF of 5 years duration or less.

    4. 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.

    5. 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:

    1. Women who are pregnant or nursing.

    2. 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.

    3. Clinically important abnormal laboratory tests.

    4. Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.

    5. Acute exacerbation of IPF within 3 months of the first screening visit.

    6. Use of certain medications within 4 weeks of the first screening visit.

    7. Receipt of an investigational drug within 6 weeks of the first screening visit.

    8. 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.

    9. Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.

    10. Planned elective surgery during the study including 4 weeks following the final dose of study drug.

    11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.

    12. Inability to cooperate with study personnel or history of non-compliance to a medical regimen.

    13. Previous treatment with FG-3019.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Hospital Birmingham Alabama United States 35294
    2 Arizona Pulmonary Specialists, LTD Scottsdale Arizona United States 85258
    3 Yale University New Haven Connecticut United States 06520
    4 Central Florida Pulmonary Group, PA Orlando Florida United States 32803
    5 Tampa General Hospital Tampa Florida United States 33606
    6 Emory University Atlanta Georgia United States 30322
    7 Via Christi Hospitals Wichita, Inc. Wichita Kansas United States 67208
    8 University of Louisville Louisville Kentucky United States 40202
    9 St. Luke's Hospital Chesterfield Missouri United States 63017
    10 Rutgers-Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901
    11 Mount Sinai New York New York United States 10029
    12 The Ohio State University Columbus Ohio United States 43221
    13 Vanderbilt University Nashville Tennessee United States 37232
    14 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    15 University of Utah - Lung Health Research Salt Lake City Utah United States 84108
    16 Vermont Lung Center Colchester Vermont United States 05446
    17 Inova Fairfax Hospital Falls Church Virginia United States 22042
    18 University of Wisconsin School of Medicine & Public Health Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • FibroGen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    FibroGen
    ClinicalTrials.gov Identifier:
    NCT01262001
    Other Study ID Numbers:
    • FGCL-3019-049
    First Posted:
    Dec 17, 2010
    Last Update Posted:
    Oct 9, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Fibrosis
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Oct 9, 2019