Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis Clinical Trial

— FGCL-3019-049  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262001
• Other study ID #: FGCL-3019-049
• Status: Completed
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: June 21, 2017

Study information

• Verified date: October 2019
• Source: FibroGen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 21, 2017
• Est. primary completion date: June 26, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• 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).
• 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).

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham Hospital	Birmingham	Alabama
United States	St. Luke's Hospital	Chesterfield	Missouri
United States	Vermont Lung Center	Colchester	Vermont
United States	The Ohio State University	Columbus	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin School of Medicine & Public Health	Madison	Wisconsin
United States	Vanderbilt University	Nashville	Tennessee
United States	Rutgers-Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Mount Sinai	New York	New York
United States	Central Florida Pulmonary Group, PA	Orlando	Florida
United States	University of Utah - Lung Health Research	Salt Lake City	Utah
United States	Arizona Pulmonary Specialists, LTD	Scottsdale	Arizona
United States	Tampa General Hospital	Tampa	Florida
United States	Via Christi Hospitals Wichita, Inc.	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
FibroGen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		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
Secondary	To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF.		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
Secondary	To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF.		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
Secondary	To evaluate the effect of FG-3019 on dyspnea in subjects with IPF.		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