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Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis (FGCL-3019-049)

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: NCT01262001
Recruitment Status : Completed
First Posted : December 17, 2010
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
FibroGen

Tracking Information
First Submitted Date  ICMJE December 15, 2010
First Posted Date  ICMJE December 17, 2010
Last Update Posted Date October 9, 2019
Study Start Date  ICMJE March 2011
Actual Primary Completion Date June 26, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 30, 2013)
To determine the safety and tolerability of FG-3019 administered at doses of 15 mg/kg (Cohort 1 and Cohort 1-EX) and 30 mg/kg (Cohort 2 and Cohort 2-EX) every 3 wks for 45 weeks, and every 3 weeks thereafter for three additional treatment years. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
To determine the safety and tolerability of FG-3019 administered at a dose of 15 mg/kg by intravenous infusion every 3 weeks for 45 weeks in subjects with IPF. [ Time Frame: Up to 60 weeks total ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 30, 2013)
  • To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
  • To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
  • To evaluate the effect of FG-3019 on dyspnea in subjects with IPF. [ Time Frame: Cohort 1: Up to 60 weeks, Cohort 1-EX (original subjects): up to 109 weeks, Cohort 1-EX (subjects who complete Week 48-EX and continue in the trial): up to 151 weeks, Cohort 2: up to 58 weeks, Cohort 2-EX: up to 202 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
  • To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF. [ Time Frame: 48 weeks ]
  • To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF. [ Time Frame: 48 weeks ]
  • To evaluate the effect of FG-3019 on dyspnea in subjects with IPF. [ Time Frame: 48 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
Official Title  ICMJE A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis
Brief Summary To evaluate the safety and tolerability of FG-3019 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and the efficacy of FG-3019 for attenuating fibrosis in these subjects.
Detailed Description Major Changes: FGCL-3019-049 Protocol Amendment 3 offers long-term extension of treatment with FG-3019 to eligible Cohort 1-EX (approximately 14 subjects) and Cohort 2 (approximately 28 subjects) subjects who complete the Week 48-EX and Week 48 assessments described in Protocol Amendment 2, respectively. A subject is eligible for long-term extension of treatment if the investigator, after discussion with the Fibrogen Medical Monitor, believes that the subject would benefit from continued treatment with FG-3019.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
FG-3019 administered at dose of 15 mg/kg (Cohort 1 ) by IV infusion every 3 weeks for 45 weeks in the target population.(first treatment year and first extended treatment year) and every 3 weeks thereafter for three additional extended treatment years.
Masking: None (Open Label)
Masking Description:
FG-3019 administered at dose of 30 mg/kg (Cohort 2 ) by IV infusion every 3 weeks for 45 weeks in the target population.(first treatment year and first extended treatment year) and every 3 weeks thereafter for three additional extended treatment years.
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Pulmonary Fibrosis
Intervention  ICMJE
  • Drug: FG-3019
    Cohort 1 and Cohort 1-EX: 15 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).
    Other Name: Pamrevlumab
  • Drug: FG-3019
    Cohort 2 and Cohort 2-EX: 30 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).
    Other Name: Pamrevlumab
Study Arms  ICMJE
  • Experimental: Cohort 1/1-EX
    Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
    Intervention: Drug: FG-3019
  • Experimental: Cohort 2/2-EX
    Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
    Intervention: Drug: FG-3019
Publications * Raghu G, Scholand MB, de Andrade J, Lancaster L, Mageto Y, Goldin J, Brown KK, Flaherty KR, Wencel M, Wanger J, Neff T, Valone F, Stauffer J, Porter S. FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in idiopathic pulmonary fibrosis. Eur Respir J. 2016 May;47(5):1481-91. doi: 10.1183/13993003.01030-2015. Epub 2016 Mar 10.

*   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: February 17, 2017)
90
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2010)
48
Actual Study Completion Date  ICMJE June 21, 2017
Actual Primary Completion Date June 26, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Main Inclusion Criteria:

  1. Age 35 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 5 years duration or less.
  4. Evidence of progression of IPF within the last 3-12 months for Cohort 1, or within the last 18 months for Cohort 2 before 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.

Main 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 within 4 weeks of the first screening visit.
  7. Receipt of an investigational drug within 6 weeks of the first screening visit.
  8. 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.
  9. Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.
  10. Planned elective surgery during the study including 4 weeks following the final dose of study drug.
  11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
  12. Inability to cooperate with study personnel or history of non-compliance to a medical regimen.
  13. Previous treatment with FG-3019.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01262001
Other Study ID Numbers  ICMJE FGCL-3019-049
Has Data Monitoring Committee No
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 Not Provided
PRS Account FibroGen
Verification Date October 2019

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