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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01890265
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE June 24, 2013
First Posted Date  ICMJE July 1, 2013
Last Update Posted Date May 3, 2019
Study Start Date  ICMJE June 2013
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
Change from baseline in FVC (percent of predicted value) at Week 48. [ Time Frame: Day 1 to Week 48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2016)
  • 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 ]
  • Change from baseline in HRQoL [ Time Frame: Week 24, Week 48, and later time points ]
  • 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: ]
    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 55 ]
  • Proportion of subjects with respiratory-related death, censored at Week 55. [ Time Frame: Week 55 ]
  • Categorical assessment of absolute change from baseline in FVC percent of predicted value at Week 48 [ Time Frame: Week 48 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2013)
  • Change from baseline in health-related quality of life at Week 48. [ Time Frame: Day 1 to Week 48 ]
  • Change from baseline in subject-reported dyspnea at Week 48. [ Time Frame: 48 weeks ]
  • 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: ]
    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 ]
  • Proportion of subjects with respiratory-related death, censored at Week 52. [ Time Frame: Week 52 ]
  • Categorical assessment of absolute change from baseline in FVC percent of predicted value at Week 48 [ Time Frame: Week 48 ]
  • Change from baseline to Week 48 in computer-assisted scores of percent of area of lung parenchymal fibrosis [ Time Frame: Baseline to Week 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis
Brief Summary 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.
Detailed Description

The study has been amended accordingly in February 2016 to further allow for the enrollment of a subgroup of subjects (N=60) who will be allowed to receive treatment with approved IPF therapy with pirfenidone or with nintedanib as background therapy.

These additional subjects will be stratified by background therapy, randomized to FG-3019 or placebo and followed up for 24 weeks. The main objective of the study remains safety. PK samples to assess drug concentrations will also be collected.

(This substudy portion only applies to US and Canadian centers.)

Enrollment for the main study was completed on 29Jun2016 Enrollment for the sub-study was completed on 16Dec2016

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: FG-3019
    FG-3019, 30 mg/kg by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks
    Other Names:
    • Fully human recombinant IgG, kappa monoclonal anti-body.
    • Pamrevlumavb
  • Drug: Placebo
    Placebo, 30 mg/kg by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks
  • Drug: Sub-study: Pirfenidone
    Subjects in the Active Comparator Arm are receiving background treatment with IPF-approved medications during the study according to the instructions in their respective labels and the prescribing physician.
    Other Name: Esbeiet
  • Drug: Sub-study: Nintedanib
    Subjects in this Active Comparator Arm are receiving background treatment with IPF-approved medications during the study according to the instructions in their respective labels and the prescribing physician.
    Other Name: Ofev
  • Drug: Sub-study: FG-3019
    FG-3019 by intravenous infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with FG-3019 in all active comparator subjects will be administered at a dose of 15 mg/kg for the first two dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg.
    Other Names:
    • Fully human recombinant IgG, kappa monoclonal anti-body.
    • Pamrevlumavb
  • Drug: Sub-study: Placebo
    Placebo by intravenous infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator subjects will be administered at a dose of 15 mg/kg for the first two dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg.
Study Arms  ICMJE
  • Experimental: Arm A (FG-3019)
    FG-3019, 30 mg/kg by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks
    Intervention: Drug: FG-3019
  • Experimental: Arm B (Placebo)
    Placebo, 30 mg/kg by intravenous infusion every 3 weeks for a total of 16 infusions over 45 weeks
    Intervention: Drug: Placebo
  • Active Comparator: Sub-study: FG-3019+pirfenidone or nintedanib

    FG-3019 by intravenous infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with FG-3019 in all active comparator subjects will be administered at a dose of 15 mg/kg for the first two dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg.

    Pirfenidone or nintedanib dosed according to the instructions in their respective labels and the prescribing physician

    Interventions:
    • Drug: Sub-study: Pirfenidone
    • Drug: Sub-study: Nintedanib
    • Drug: Sub-study: FG-3019
  • Placebo Comparator: Sub-study: Placebo+pirfenidone or nintedanib

    Placebo by intravenous infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator subjects will be administered at a dose of 15 mg/kg for the first two dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg.

    Pirfenidone or nintedanib dosed according to the instructions in their respective labels and the prescribing physician

    Interventions:
    • Drug: Sub-study: Pirfenidone
    • Drug: Sub-study: Nintedanib
    • Drug: Sub-study: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2016)
160
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2013)
90
Actual Study Completion Date  ICMJE November 16, 2017
Actual Primary Completion Date July 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  9. For Substudy only: Receiving treatment for IPF with a stable dose of pirfenidone or with a stable dose of nintedanib for at least 3 months before screening initiation and willing to continue treatment with pirfenidone or with nintedanib according to the corresponding approved label and the prescribing physician, including all listed safety requirements (e.g., liver function tests, avoidance of sunlight and sunlamp exposure and wearing of sunscreen and protective clothing daily for pirfenidone, and smoking cessation).

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. This applies to subject enrolled in Main Study only.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   India,   New Zealand,   South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01890265
Other Study ID Numbers  ICMJE FGCL-3019-067
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party FibroGen
Study Sponsor  ICMJE FibroGen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Wencel, M.D Via Christi Clinic, P.A., USA
Principal Investigator: Joao de Andrade, M.D The Kirklin Clinic, USA
Principal Investigator: Peter LaCamera, M.D. Steward St. Elizabeth's Medical Center, USA
Principal Investigator: Danielle Antin-Ozerkis, M.D. Yale University, USA
Principal Investigator: Rishi Raj, M.D. Northwestern University
Principal Investigator: Neil Ettinger, M.D St Luke's Hospital, USA
Principal Investigator: Rafael Perez, M.D University of Louisville, USA
Principal Investigator: Timothy Albertson, M.D University of California Davis Medical Center, USA
Principal Investigator: Yolanda Mageto, M.D. Vermont Lung Center, USA
Principal Investigator: Srihari Veeraraghavan, M.D Emory University, USA
Principal Investigator: Nishant Gupta, M.D University of Cinncinati, USA
Principal Investigator: Kevin Gibson, M.D University of Pittsburgh Medical Center, USA
Principal Investigator: Lisa Lancaster, M.D. Vanderbilt University, USA
Principal Investigator: Mary Beth Scholand, M.D. University of Utah - Lung Health Research, USA
Principal Investigator: Mark Hamblin, M.D. University of Kansas Medical Center, USA
Principal Investigator: John Fitzgerald, M.D. University of Texas Southwestern Medical Center, USA
Principal Investigator: John Belperio, M.D. David Geffen School of Medicine at UCLA, USA
Principal Investigator: Richard Enelow, M.D. Dartmouth-Hitchcock Medical Center, USA
Principal Investigator: Evans R Fernandez-Perez, M.D National Jewish Center, USA
Principal Investigator: Peter A Bercz, M.D Pensacola Research Consultants, INC., USA
Principal Investigator: Krishna Thavarajah, M.D. Henry Ford Medical Center, USA
Principal Investigator: James Britt, M.D. University of Maryland, College Park
Principal Investigator: Danielle D. Hosmer Legacy Research Institute, USA
Principal Investigator: David Lederer, M.D. Columbia University Medical Center, USA
Principal Investigator: Murali Ramaswamy, M.D. PulmonIx LLC, USA
Principal Investigator: Thomas O'Brien, M.D. Pulmonary Disease Specialist, PA, USA
Principal Investigator: Nadim Srour, M.D. Université de Sherbrooke / Hôpital Charles LeMoyne, Canada
Principal Investigator: Elvis Irusen, M.D. Tygerberg Hospital Respiratory Research Unit, South Africa
Principal Investigator: Anish Ambaram, M.D. Life Mount Edgecombe Hospital, South Africa
Principal Investigator: Heidi Siebert, M.D. Into Research, South Africa
Principal Investigator: Elizabeth Veitch, M.D. Concord Repatriation, Australia
Principal Investigator: Huw Davies, M.D. Daw Park Repatriation, Australia
Principal Investigator: Lutz Beckert, M.D. Christchurch Hospital NZ, New Zealand
Principal Investigator: Catherina Chang, M.D. Waikato Hospital, New Zealand
Principal Investigator: Benedict Brockway, M.D. Dunedin Public Hospital, New Zealand
Principal Investigator: Suzanne Poole, M.D. Tauranga Hospital, New Zealand
Principal Investigator: Raja Dhar, M.D. Fortis Hospitals, India
Principal Investigator: Bhanu Singh, M.D. Midland Healthcare & Research Center, India
Principal Investigator: Nandagopal Velayuthaswamy, M.D. Sri Bala Medical Centre and Hospital, India
Principal Investigator: Sujeet Rajan, M.D. Bhatia Hospital, India
Principal Investigator: Priya Ramachandran, M.D. St Johns Medical College Hospital, India
Principal Investigator: Natalia Stoeva, M.D. MHAT 'Tokuda Hospital Sofia', AD, Department of Pulmonology, Bulgaria
PRS Account FibroGen
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP