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

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

Tracking Information

• First Submitted Date: December 15, 2010
• First Posted Date: December 17, 2010
• Last Update Posted Date: October 9, 2019
• Study Start Date: March 2011
• Actual Primary Completion Date: June 26, 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis
• 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
• 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: Interventional
• Study Phase: Phase 2

Study Design

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: Idiopathic Pulmonary Fibrosis

Intervention

• 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

• 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.

Recruitment Information

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

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 35 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01262001
• Other Study ID Numbers: FGCL-3019-049
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: FibroGen
• Study Sponsor: FibroGen
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: FibroGen
• Verification Date: October 2019