Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

NCT ID: NCT01262001

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2017-06-21

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1/1-EX

Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression

Group Type: EXPERIMENTAL

FG-3019

Intervention Type: DRUG

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).

Cohort 2/2-EX

Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression

Group Type: EXPERIMENTAL

FG-3019

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Pamrevlumab; Pamrevlumab

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FibroGen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Arizona Pulmonary Specialists, LTD

Scottsdale, Arizona, United States

Yale University

New Haven, Connecticut, United States

Central Florida Pulmonary Group, PA

Orlando, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Via Christi Hospitals Wichita, Inc.

Wichita, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

St. Luke's Hospital

Chesterfield, Missouri, United States

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Mount Sinai

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Utah - Lung Health Research

Salt Lake City, Utah, United States

Vermont Lung Center

Colchester, Vermont, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, United States

Countries

United States

References

Kim GH, Zhang X, Brown MS, Poole L, Goldin J. Minimum clinically important difference in Quantitative Lung Fibrosis score associated with all-cause mortality in idiopathic pulmonary fibrosis: subanalysis from two phase II trials of pamrevlumab. BMJ Open. 2025 May 12;15(5):e094559. doi: 10.1136/bmjopen-2024-094559.

Reference Type: DERIVED

PMID: 40355288 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26965296 (View on PubMed)

Other Identifiers

FGCL-3019-049

Identifier Type: -

Identifier Source: org_study_id