Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

NCT01262001 | Completed Phase 2

• 1 other identifier: FGCL-3019-049
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 18

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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Cohort 1/1-EX

EXPERIMENTAL

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

Drug: FG-3019

Cohort 2/2-EX

EXPERIMENTAL

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

Drug: FG-3019

Interventions

FG-3019 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).

Also known as: Pamrevlumab

Cohort 1/1-EX

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (18)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35294, United States

Location

Arizona Pulmonary Specialists, LTD

Scottsdale, Arizona, 85258, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Central Florida Pulmonary Group, PA

Orlando, Florida, 32803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Via Christi Hospitals Wichita, Inc.

Wichita, Kansas, 67208, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Rutgers-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Utah - Lung Health Research

Salt Lake City, Utah, 84108, United States

Location

Vermont Lung Center

Colchester, Vermont, 05446, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

University of Wisconsin School of Medicine & Public Health

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• 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.

  PMID: 40355288 DERIVED

• 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.

  PMID: 26965296 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pamrevlumab

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: March 1, 2011
• Primary Completion: June 26, 2014
• Study Completion: June 21, 2017
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

US (18)