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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1/1-EX | Experimental | Subjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression |
|
| Cohort 2/2-EX | Experimental | Subjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35294 | United States | ||
| Arizona Pulmonary Specialists, LTD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40355288 | Derived | 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. | |
| 26965296 | Derived |
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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.
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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.
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|
| FG-3019 | 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). |
|
|
| 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 |
| Scottsdale |
| Arizona |
| 85258 |
| United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Central Florida Pulmonary Group, PA | Orlando | Florida | 32803 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Via Christi Hospitals Wichita, Inc. | Wichita | Kansas | 67208 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| St. Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| Mount Sinai | New York | New York | 10029 | United States |
| The Ohio State University | Columbus | Ohio | 43221 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Utah - Lung Health Research | Salt Lake City | Utah | 84108 | United States |
| Vermont Lung Center | Colchester | Vermont | 05446 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| University of Wisconsin School of Medicine & Public Health | Madison | Wisconsin | 53705 | United States |
| 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. |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C560078 | pamrevlumab |
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