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Idiopathic Pulmonary FibrosisPhase 2FGCL-3019-049NCT01262001

Safety, Tolerability, and Efficacy Study of Idiopathic Pulmonary Fibrosis

A Phase 2 study testing FG-3019 in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
FG-3019
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
18 sitesUnited States
Study dates
Mar 2011to 21 Jun 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35294

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017

  • Vermont Lung Center

    Colchester, Vermont, 05446

  • The Ohio State University

    Columbus, Ohio, 43221

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin School of Medicine & Public Health

    Madison, Wisconsin, 53705

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Rutgers-Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08901

  • Yale University

    New Haven, Connecticut, 06520

  • Mount Sinai

    New York, New York, 10029

  • Central Florida Pulmonary Group, PA

    Orlando, Florida, 32803

  • University of Utah - Lung Health Research

    Salt Lake City, Utah, 84108

  • Arizona Pulmonary Specialists, LTD

    Scottsdale, Arizona, 85258

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Via Christi Hospitals Wichita, Inc.

    Wichita, Kansas, 67208

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
FG-3019
Medical subject headings
Idiopathic Pulmonary Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FG-3019Drug

    Also called Pamrevlumab

    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-3019Drug

    Also called Pamrevlumab

    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).

Study groups in NCT01262001
Study groupRoleWhat they receive
Cohort 1/1-EXExperimentalSubjects with moderate to severe idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
Receives: Drug: FG-3019
Cohort 2/2-EXExperimentalSubjects with mild to moderate idiopathic pulmonary fibrosis (IPF) who have evidence of disease progression
Receives: Drug: FG-3019

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. To evaluate the effect of FG-3019 on the extent of pulmonary fibrosis in subjects with IPF.

    Measured: 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

  2. To evaluate the effect of FG-3019 on pulmonary function in subjects with IPF.

    Measured: 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

  3. To evaluate the effect of FG-3019 on dyspnea in subjects with IPF.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2010 (estimated)
  2. Study startMar 2011
  3. Primary completion26 Jun 2014
  4. Study completion21 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01262001
Sponsor's protocol ID
FGCL-3019-049
Acronym
FGCL-3019-049
Status last verified
Oct 2019
First submitted
15 Dec 2010
Last updated
9 Oct 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 40355288

  • 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.

    PubMed 26965296

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FG-3019 in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01262001, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.

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