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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by FibroGen
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01890265
First received: June 24, 2013
Last updated: July 24, 2014
Last verified: July 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
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, see Learn About Clinical Studies.

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

  Show 21 Study Locations
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: Timothy Albertson, 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
Principal Investigator: Lisa Lancaster, M.D. Vanderbilt University
Principal Investigator: Mary Scholand, M.D. University of Utah - Lung Health Research
Principal Investigator: Jonathan Ruzi, M.D. Arizona Pulmonary Specialists, LTD
Principal Investigator: Mark Rolfe, M.D. Tampa General Hospital
Principal Investigator: Mark Hamblin, M.D. University of Kansas
Principal Investigator: Daniel Culver, D.O. The Cleveland Clinic
  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: July 24, 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 July 28, 2014