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

Tracking Information
First Submitted Date ICMJE	December 15, 2010
First Posted Date ICMJE	December 17, 2010
Last Update Posted Date	August 4, 2017
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	Complete list of historical versions of study NCT01262001 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Idiopathic Pulmonary Fibrosis
Intervention ICMJE	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..
Study Arms	Not Provided
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	June 21, 2017
Actual Primary Completion Date	June 26, 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Main Inclusion Criteria: Age 35 to 80 years, inclusive.; 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).; History of IPF of 5 years duration or less.; 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.; 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: Women who are pregnant or nursing.; 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.; Clinically important abnormal laboratory tests.; Upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit.; Acute exacerbation of IPF within 3 months of the first screening visit.; Use of certain medications within 4 weeks of the first screening visit.; Receipt of an investigational drug within 6 weeks of the first screening visit.; 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.; Trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit.; Planned elective surgery during the study including 4 weeks following the final dose of study drug.; History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.; Inability to cooperate with study personnel or history of non-compliance to a medical regimen.; Previous treatment with FG-3019.
Sex/Gender	Sexes Eligible for Study: All
Ages	35 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	FibroGen
Study Sponsor ICMJE	FibroGen
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	FibroGen
Verification Date	August 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP