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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 December 2015 by FibroGen
Information provided by (Responsible Party):
FibroGen Identifier:
First received: June 24, 2013
Last updated: December 16, 2015
Last verified: December 2015
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 in pulmonary fibrosis score by quantitative HRCT at Week 24, Week 48, and later time points. [ Time Frame: Week 24, Week 48, and later time points ] [ Designated as safety issue: Yes ]
  • Change from baseline in HRQoL [ Time Frame: Week 24, Week 48, and later time points ] [ 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. Death from any cause.
    2. Absolute decline in FVC % of predicted value of ≥10% not due to intercurrent illness, confirmed by repeat spirometry.
    3. Clinical diagnosis of IPF progression.
    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 ]

Estimated Enrollment: 136
Study Start Date: June 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: February 2017 (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


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

Inclusion Criteria:

  1. Age 40 to 80 years, inclusive.
  2. Diagnosis of IPF as defined by current international guidelines (Raghu, 2011). Each subject must have one of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern on an available HRCT scan; or (2) Possible UIP Pattern on an available HRCT scan and surgical lung biopsy within 4 years of Screening showing UIP Pattern.
  3. History of IPF of ≤5 years duration with onset defined as the date of the first diagnosis of IPF by HRCT or surgical lung biopsy.
  4. Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the whole lung, as determined by the HRCT central reader.
  5. FVC percent of predicted value ≥55% at Screening.
  6. Female subjects of childbearing potential (including those <1 year postmenopausal) must be willing to use a medically acceptable method of contraception, for example, an oral contraceptive, depot progesterone, or intrauterine device. Male subjects with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (e.g., condom) if not surgically sterile (i.e., vasectomy).
  7. All subjects in Arm A whose FVC percent predicted value is greater than the original pre-treatment baseline in the Randomized Treatment Period will be offered participation in an Extended Treatment Period
  8. All subjects assigned to Placebo (Arm B) will be offered participation in the Extended Treatment Phase.

Exclusion Criteria:

  1. Women who are pregnant or nursing.
  2. Infiltrative lung disease other than IPF, including any of the other types of idiopathic interstitial pneumonias (Travis, 2013); lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis and connective tissue diseases.
  3. HRCT scan findings at Screening are inconsistent with UIP Pattern, as determined by the HRCT central reader.
  4. Pathology diagnosis on surgical lung biopsy is anything other than UIP Pattern, as determined by the local pathologist.
  5. The Investigator judges that there has been sustained improvement in the severity of IPF during the 12 months prior to Screening, based on changes in FVC, diffusing capacity of the lung for carbon monoxide (DLCO), and/or HRCT scans of the chest.
  6. Clinically important abnormal laboratory tests.
  7. Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.
  8. Acute exacerbation of IPF within 3 months of the first screening visit.
  9. Use of medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal antibodies were used, the last dose of the antibody must be at least 4 weeks before Day 1 dosing.
  10. Use of any investigational drugs, including any investigational drugs for IPF, within 4 weeks prior to Day 1 dosing.
  11. History of cancer diagnosis of any type in the 3 years preceding Screening, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cancers
  12. Diffusing capacity (DLCO) less than 30% of predicted value
  13. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
  14. Previous treatment with FG-3019.
  15. 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 identifier: NCT01890265

Contact: Lisa Bacolini 415-978-1369
Contact: Jocelyne Gonzalez 415-978-1361

  Show 26 Study Locations
Sponsors and Collaborators
Principal Investigator: Mark Wencel, M.D Via Christi Clinic, P.A.
Principal Investigator: Joao de Andrade, M.D The Kirklin Clinic
Principal Investigator: Peter LaCamera, M.D. Steward St. Elizabeth's Medical Center
Principal Investigator: Danielle Antin-Ozerkis, M.D. Yale 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: Yolanda Mageto, M.D. Vermont Lung Center
Principal Investigator: Srihari Veeraraghavan, M.D Emory University
Principal Investigator: Nishant Gupta, M.D University of Cinncinati
Principal Investigator: Daniel Kass, 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 Hamblin, M.D. University of Kansas Medical Center
Principal Investigator: Leslie Tolle, M.D. The Cleveland Clinic
Principal Investigator: John Fitzgerald, M.D. University of Texas Southwestern Medical Center
Principal Investigator: John Belperio, M.D. University of California, Los Angeles
Principal Investigator: Richard Enelow, M.D. Dartmouth-Hitchcock Medical Center
Principal Investigator: Evans R Fernandez-Perez, M.D National Jewish Center
Principal Investigator: Peter A Bercz, M.D Pensacola Research Consultants, INC.
Principal Investigator: Krishna Thavarajah, M.D. Henry Ford Medical Center
Principal Investigator: James Britt, M.D. University of Maryland
Principal Investigator: Danielle D. Hosmer Legacy Research Institute
Principal Investigator: Nadim Srour, M.D. Université de Sherbrooke / Hôpital Charles LeMoyne
  More Information

Responsible Party: FibroGen Identifier: NCT01890265     History of Changes
Other Study ID Numbers: FGCL-3019-067 
Study First Received: June 24, 2013
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
New Zealand: Medsafe
India: Drugs Controller General of India
South Africa: Medicines Control Council

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

Additional relevant MeSH terms:
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases processed this record on February 11, 2016