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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01262001
First received: December 15, 2010
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: FG-3019
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of FG-3019 in Subjects With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: March 2011
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: FG-3019
    15 mg/kg (Cohort 1 and Cohort 1-Extension) and 30 mg/kg (Cohort 2 and Cohort 2-EX) 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..
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.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01262001

Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Florida
Orlando, Florida, United States, 32803
Tampa, Florida, United States, 33606
United States, Georgia
Decatur, Georgia, United States, 30033
United States, Kansas
Wichita, Kansas, United States, 67208
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Missouri
Chesterfield, Missouri, United States, 63017
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
New York, New York, United States, 10029
United States, Ohio
Columbus, Ohio, United States, 43221
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75390
United States, Utah
Salt Lake City, Utah, United States, 84108
United States, Vermont
Colchester, Vermont, United States, 05446
Sponsors and Collaborators
FibroGen
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01262001     History of Changes
Other Study ID Numbers: FGCL-3019-049
Study First Received: December 15, 2010
Last Updated: January 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on July 31, 2014