Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

This study is currently recruiting participants.
Verified February 2014 by FibroGen
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01890265
First received: June 24, 2013
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

To evaluate the safety and tolerability of FG-3019 in subjects with IPF, and the efficacy of FG-3019 in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these subjects.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: FG-3019
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • Change from baseline in FVC (percent of predicted value) at Week 48. [ Time Frame: Day 1 to Week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in health-related quality of life at Week 48. [ Time Frame: Day 1 to Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline in subject-reported dyspnea at Week 48. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Time to progression of IPF, defined as time from Day 1 to any one of the following [ Time Frame: Day 1 to anyone of the following below: ] [ Designated as safety issue: Yes ]
    1. First respiratory-related hospitalization.
    2. Respiratory-related death.
    3. Absolute decline in FVC percent of predicted value of ≥10%.
    4. Absolute decline in DLCO, adjusted for Hgb, percent of predicted value of ≥15%.

  • Proportion of subjects with at least one respiratory-related hospitalization [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with respiratory-related death, censored at Week 52. [ Time Frame: Week 52 ] [ Designated as safety issue: Yes ]
  • Categorical assessment of absolute change from baseline in FVC percent of predicted value at Week 48 [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Change from baseline to Week 48 in computer-assisted scores of percent of area of lung parenchymal fibrosis [ Time Frame: Baseline to Week 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: June 2013
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Drug (FG-3019)
Study Drug, FG-3019, 30 mg/kg; 10 mg/ml, single dose vials, by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks
Drug: FG-3019
Study Drug, FG-3019, 10 mg/ml, single dose vials, by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks
Other Name: Fully human recombinant IgG, kappa monoclonal anti-body.
Placebo Comparator: Placebo
Sterile, clear aqueous solution, 10 mg/ml, single dose vials, by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks
Drug: Placebo
Sterile, clear aqueous solution, 10 mg/ml, single dose vials, by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40 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 4 years' duration or less.
  4. Forced Vital Capacity (FVC) 55% to 90% of predicted value at 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.
  6. All subjects whose FVC percent predicted value (mean of Week 36 and Week 48 values) shows less than 3% absolute decrease from baseline (mean of Screening Visit 1 and Day 1 values) in the Randomized Treatment Phase will be offered participation in an Extended Treatment Phase.

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 and investigational drugs within 4 weeks of the first screening visit.
  7. 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.
  8. Diffusing capacity (DLCO) less than 30% of predicted value at screening.
  9. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
  10. Previous treatment with FG-3019.
  11. Body weight greater than 130 kilograms.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01890265

Contacts
Contact: John L. Stauffer, M.D 415-978-1455 jstauffer@fibrogen.com
Contact: Loredie Lugis, RN-BSN 415-978-1353 llugos@fibrogen.com

Locations
United States, Alabama
The Kirklin Clinic Recruiting
Birmingham, Alabama, United States, 35294
Contact: Joao de Andrade, M.D.    205-934-6229    joao@uab.edu   
Contact: Angela Lewis    (205) 934-6229    adlewis@uab.edu   
Principal Investigator: Joao de Andrade, M.D.         
United States, California
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Oanh Nguyen    916-734-3755    oanh.nguyen@ucdmc.ucdavis.edu   
Contact: Carolyn King    916-734-3560    carolyn.king@ucdmc.ucdavis.edu   
Principal Investigator: Andrew Chan, M.D.         
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Danielle Antin-Ozerkis, M.D.    203-785-7324    danielle.antin-ozerkis@yale.edu   
Contact: Jean Estrom    203-785-7324    jean.estrom@yale.edu   
Principal Investigator: Danielle Antin-Ozerkis, M.D.         
United States, Florida
Central Florida Pulmonary Group, PA Recruiting
Orlando, Florida, United States, 32803
Contact: Denise P Smith    407-841-1100 ext 107    dpsmith@cfpulmonary.com   
Contact: Shari Tillman, RN, BSN, CCRC    407-841-1100 ext 122    stillman@cfpulmonary.com   
Principal Investigator: Kevin DeBoer, D.O.         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Tracy Halaby, RN    404-712-7458    tracy.halaby@emory.edu   
Contact: Jane Gillespie, RN    404-712-8204    jegille@emory.edu   
Principal Investigator: Srihari Veeraraghavan, M.D         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Rishi Raj, M.D.    312-695-2269    rishi.raj@northwestern.edu   
Contact: Margaret Travis, Rn, BSN    312-695-2269    margaret.travis@northwestern.edu   
Principal Investigator: Rishi Raj, M.D.         
United States, Kansas
Via Christi Clinic, P.A. Recruiting
Wichita, Kansas, United States, 67208
Contact: Mark Wencel, MD    316-689-9542    mark.wencel@viachristi.org   
Contact: Angel Vincent    316-689-9542    angela.vincent@viachristi.org   
Principal Investigator: Mark Wencel, M.D         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Tamra Perez    502-852-1358    tamra.perez@louisville.edu   
Contact: Heidi Wilson    502-852-0560    Heidi.wilson@louisville.edu   
Principal Investigator: Rafael Perez, M.D         
United States, Massachusetts
Steward St. Elizabeth's Medical Center Recruiting
Boston, Massachusetts, United States, 02135
Contact: Peter LaCamera, M.D.    617-789-2078    peter.lacamera@steward.org   
Contact: Arthur Dea    617-789-2078    arthur.dea@steward.org   
Principal Investigator: Peter LaCamera, M.D.         
United States, Missouri
St. Luke's Hospital Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Ann Shipp, RRT, CCRC    314-576-4501    anna.shipp@stlukes-stl.com   
Contact: Sue Meril, RRT, CCRC    314-576-4501    sue.merli@stlukes-stl.com   
Principal Investigator: Neil Ettinger, M.D         
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
Brunswick, New Jersey, United States, 08903
Contact: David Riley, M.D.    732-418-8483    riley@umdnj.edu   
Contact: Halina Malveaux    732-418-8483    malveaha@umdnj.edu   
Principal Investigator: David Riley, M.D.         
United States, Ohio
University of Cinncinati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Becky Ingledue, CCRC    513-558-0027    Rebecca.Ingledue@uc.edu   
Contact: Tammy Roads, CCRC    513-558-2148    roadst@uc.mail.edu   
Principal Investigator: Markus Gutsche, M.D         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: James Allen, M.D.    614-366-2361    James.Allen@osumc.edu   
Contact: Rachael Compton    614-366-2361    Rachael.compton@osumc.edu   
Principal Investigator: James Allen, M.D.         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Michelle Meyers, BSN, RN    412-692-2149    meyersma@upmc.edu   
Contact: Michelle MacPherson    412-647-4537    macphersonmj@upmc.edu   
Principal Investigator: Kevin Gibson, M.D         
United States, Vermont
Vermont Lung Center Recruiting
Colchester, Vermont, United States, 05446
Contact: Patricia Lutton, B.A., CCRP    802-847-2160    patricia.lutton@vtmednet.org   
Contact: Joan Lippmann, B.S.    802-847-6982    joan.lippmann@vtmednet.org   
Principal Investigator: Yolanda Mageto, M.D.         
Sponsors and Collaborators
FibroGen
Investigators
Principal Investigator: Mark Wencel, M.D Via Christi Clinic, P.A.
Principal Investigator: Joao de Andrade, M.D The Kirklin Clinic
Principal Investigator: David Riley, M.D. Rutgers, The State University of New Jersey
Principal Investigator: Peter LaCamera, M.D. Steward St. Elizabeth's Medical Center
Principal Investigator: Danielle Antin-Ozerkis, M.D. Yale University
Principal Investigator: James Allen, M.D. Ohio State University
Principal Investigator: Rishi Raj, M.D. Northwestern University
Principal Investigator: Neil Ettinger, M.D St Luke's Hospital
Principal Investigator: Rafael Perez, M.D University of Louisville
Principal Investigator: Andrew Chan, M.D University of California, Davis
Principal Investigator: Kevin DeBoer, D.O. Central Florida Pulmonary Group, PA
Principal Investigator: Yolanda Mageto, M.D. Vermont Lung Center
Principal Investigator: Srihari Veeraraghavan, M.D Emory University
Principal Investigator: Markus Gutsche, M.D University of Cinncinati
Principal Investigator: Kevin Gibson, M.D University of Pittsburgh
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01890265     History of Changes
Other Study ID Numbers: FGCL-3019-067
Study First Received: June 24, 2013
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by FibroGen:
Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis

Additional relevant MeSH terms:
Idiopathic Pulmonary Fibrosis
Fibrosis
Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014