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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 July 2016 by FibroGen
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01890265
First received: June 24, 2013
Last updated: July 28, 2016
Last verified: July 2016
  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 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 55 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with respiratory-related death, censored at Week 55. [ Time Frame: Week 55 ] [ 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: July 2017
Estimated Primary Completion Date: June 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

For the substudy, the dose will be the same but for a total of 8 infusions over 21 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

For the substudy, the dose will be the same but for a total of 8 infusions over 21 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

For the substudy, the dose will be the same but for a total of 8 infusions over 21 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

For the substudy, the dose will be the same but for a total of 8 infusions over 21 weeks


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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: Lisa Bacolini 415-978-1369 lbacolini@fibrogen.com
Contact: Joyce Alejo-Stone 415-978-1365 JAlejo-Stone@Fibrogen.com

  Show 44 Study Locations
Sponsors and Collaborators
FibroGen
Investigators
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: Jonathan Ruzi, M.D. Arizona Pulmonary Specialists, LTD, 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
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: Daniel Dilling, M.D. Loyola University Medical Center, 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
  More Information

Publications:
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 28, 2016
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
Bulgaria: Bulgarian Drug Agency

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

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

ClinicalTrials.gov processed this record on December 07, 2016