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Idiopathic Pulmonary FibrosisPhase 2NCT01890265

Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 2 study testing Pamrevlumab, Sub-Study: Pirfenidone and Sub-Study: Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 42 sites in 7 countries.

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 pamrevlumab in participants with IPF, and the efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these participants. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Pamrevlumab, Sub-Study: Pirfenidone and Sub-Study: Nintedanib
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
42 sitesin 7 countries
Study dates
30 Jul 2013to 16 Nov 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Age 40 to 80 years, inclusive.
  • Diagnosis of IPF as defined by current international guidelines. Each participant must have 1 of the following: (1) Usual Interstitial Pneumonia (UIP) Pattern on an available high-resolution computed tomography (HRCT) scan; or (2) Possible UIP Pattern on an available HRCT scan and surgical lung biopsy within 4 years of Screening showing UIP Pattern.
  • History of IPF of ≤5 years duration with onset defined as the date of the first diagnosis of IPF by HRCT or surgical lung biopsy.
  • Interstitial pulmonary fibrosis defined by HRCT scan at Screening, with evidence of ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing, within the whole lung, as determined by the HRCT central reader.
  • FVC percent of predicted value ≥55% at Screening.
  • Female participants of childbearing potential (including those <1 year postmenopausal) must be willing to use a medically acceptable method of contraception, for example, an oral contraceptive, depot progesterone, or intrauterine device. Male participants with female partners of childbearing potential who are not using birth control as described above must use a barrier method of contraception (for example, condom) if not surgically sterile (for example, vasectomy).
  • For sub-study only: Receiving treatment for IPF with a stable dose of pirfenidone or with a stable dose of nintedanib for at least 3 months before Screening initiation and willing to continue treatment with pirfenidone or with nintedanib according to the corresponding approved label and the prescribing physician, including all listed safety requirements (for example, liver function tests, avoidance of sunlight and sunlamp exposure and wearing of sunscreen and protective clothing daily for pirfenidone, and smoking cessation).

Who cannot join

  • Women who are pregnant or nursing.
  • Infiltrative lung disease other than IPF, including any of the other types of idiopathic interstitial pneumonias (Travis, 2013); lung diseases related to exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; systemic diseases, including vasculitis and connective tissue diseases.
  • HRCT scan findings at Screening are inconsistent with UIP Pattern, as determined by the HRCT central reader.
  • Pathology diagnosis on surgical lung biopsy is anything other than UIP Pattern, as determined by the local pathologist.
  • The Investigator judges that there has been sustained improvement in the severity of IPF during the 12 months prior to Screening, based on changes in FVC, diffusing capacity of the lung for carbon monoxide (DLCO), and/or HRCT scans of the chest.
  • Clinically important abnormal laboratory tests.
Show all 15Show fewer
  • 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 medications to treat IPF within 5 half-lives of Day 1 dosing. If monoclonal antibodies were used, the last dose of the antibody must be at least 4 weeks before Day 1 dosing. This applies to participants enrolled in Main Study only.
  • Use of any investigational drugs, including any investigational drugs for IPF, within 4 weeks prior to Day 1 dosing.
  • History of cancer diagnosis of any type in the 3 years preceding Screening, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cancers.
  • Diffusing capacity (DLCO) less than 30% of predicted value.
  • History of allergic or anaphylactic reaction to human, humanized, chimeric, or murine monoclonal antibodies.
  • Previous treatment with FG-3019.
  • Body weight greater than 130 kilograms.

Trial locations and contacts

42 sites in 7 countries.

42 sites in 7 countries

United States26 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • The Kirklin Clinic

    Birmingham, Alabama, 35294

  • Steward St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • St. Luke's Hospital

    Chesterfield, Missouri, 63017

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cinncinati

    Cincinnati, Ohio, 45267

  • Vermont Lung Center

    Colchester, Vermont, 05446

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80206

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • PulmonIx LLC

    Greensboro, North Carolina, 27403

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Pulmonary Disease Specialist, PA

    Kissimmee, Florida, 34741

  • Dartmouth-Hitchcock Medical Center

    Lebanon, Ohio, 03756

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90024

  • University of Louisville

    Louisville, Kentucky, 40202

  • Vanderbilt University

    Nashville, Tennessee, 37232-5735

  • Yale University

    New Haven, Connecticut, 06520

  • Columbia University Medical Center

    New York, New York, 10032

  • Pensacola Research Consultants, Inc., d.b.a. Avanza Medical Research Center

    Pensacola, Florida, 32504

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Legacy Research Institute

    Portland, Oregon, 97210

  • UC Davis Medical Center

    Sacramento, California, 95817

  • University of Utah - Lung Health Research

    Salt Lake City, Utah, 84108

  • Via Christi Clinic, P.A.

    Wichita, Kansas, 67208

Other trials in United States

India5 sites

  • St Johns Medical College Hospital

    Bangalore, Karnataka, 560034

  • Sri Bala Medical Centre and Hospital

    Coimbatore, Tamil Nadu, 641045

  • Fortis Hospitals

    Kolkata, West Bengal, 700107

  • Midland Healthcare & Research Center

    Lucknow, Uttar Pradesh, 226006

  • Bhatia Hospital

    Mumbai, Maharashtra, 400007

Other trials in India

New Zealand4 sites

  • Christchurch Hospital NZ

    Christchurch, 8011

  • Dunedin Public Hospital

    Dunedin, 9016

  • Waikato Hospital

    Hamilton, 3204

  • Tauranga Hospital

    Tauranga, 3143

Other trials in New Zealand

South Africa3 sites

  • Tygerberg Hospital Respiratory Research Unit

    Cape Town, Western Cape, 7505

  • Life Mount Edgecombe Hospital

    Durban, KwaZulu-Natal, 4068

  • Into Research

    Pretoria, Gauteng, 0181

Other trials in South Africa

Australia2 sites

  • Daw Park Repatriation

    Adelaide, South Australia, 5041

  • Concord Repatriation

    Concord, New South Wales, 2139

Other trials in Australia

Bulgaria1 site

  • MHAT 'Tokuda Hospital Sofia', AD, Department of Pulmonology

    Sofia, 1407

Other trials in Bulgaria

Canada1 site

  • Université de Sherbrooke / Hôpital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

Other trials in Canada

About this study

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of FG-3019 in Patients With Idiopathic Pulmonary Fibrosis

To evaluate the safety and tolerability of pamrevlumab in participants with IPF, and the efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these participants.

Read the detailed description

The study has been amended in February 2016 to further allow for the enrollment of a subgroup of participants (N=60) who will be allowed to receive treatment with approved IPF therapy with pirfenidone or with nintedanib as concomitant therapy.

These additional participants will be stratified by background therapy, randomized to pamrevlumab or placebo, and followed up for 24 weeks. The main objective of the study remains safety. Pharmacokinetic (PK) samples to assess drug concentrations will also be collected.

This sub-study portion only applies to a select United States centers.

Enrollment for the main study was completed on 29 June 2016. Enrollment for the sub-study was completed on 16 December 2016.

Being tested
Pamrevlumab, Placebo, Sub-Study: Pirfenidone, Sub-Study: Nintedanib
Keywords
Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial Pneumonias, Lung Diseases, Interstitial, Pulmonary Fibrosis

What participants receive

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

  • PamrevlumabDrug

    Also called Fully human recombinant immunoglobulin G (IgG), kappa monoclonal anti-body., FG-3019

    Solution for infusion

  • PlaceboDrug

    Solution for infusion

  • Sub-Study: PirfenidoneDrug

    Also called Esbeiet

    Pirfenidone concomitant therapy will not be provided by the Sponsor.

  • Sub-Study: NintedanibDrug

    Also called Ofev

    Nintedanib concomitant therapy will not be provided by the Sponsor.

Study groups in NCT01890265
Study groupRoleWhat they receive
PamrevlumabExperimentalParticipants will receive pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Receives: Drug: Pamrevlumab
PlaceboPlacebo comparatorParticipants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.
Receives: Drug: Placebo
Sub-Study: Pamrevlumab+Pirfenidone or NintedanibActive comparatorParticipants will receive pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with pamrevlumab in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg. Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician.
Receives: Drug: Pamrevlumab; Drug: Sub-Study: Pirfenidone; Drug: Sub-Study: Nintedanib
Sub-Study: Placebo+Pirfenidone or NintedanibPlacebo comparatorParticipants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 8 infusions over 21 weeks. Initial treatment with placebo in all active comparator participants will be administered at a dose of 15 mg/kg for the first 2 dose administrations. If these are well tolerated, all following study drug administrations will be at 30 mg/kg. Pirfenidone or nintedanib will be dosed according to the instructions in their respective labels and the prescribing physician.
Receives: Drug: Placebo; Drug: Sub-Study: Pirfenidone; Drug: Sub-Study: Nintedanib

What is being measured

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

  1. Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48

    FVC in liters was measured during the spirometry assessments at screening and during the randomized treatment period at Day 1 and every 12 weeks. The FVC (% predicted) was calculated for the corresponding gender-race-age group. The least squares (LS) mean change from Baseline to Week 48 (end of the randomized treatment period) in FVC (% predicted) is presented. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Other statistical analysis data is reported in the statistical analysis section. Observed data from all visits were included in the model.

    Measured: Baseline (Screening and Day 1), Week 48

Secondary outcomes (6)

  1. Mean Change From Baseline in the HRCT Quantitative Lung Fibrosis (QLF) Score to Week 24 and Week 48

    The extent of pulmonary fibrosis was measured by HRCT scans of the chest at screening and at Weeks 24 and 48, to determine the HRCT QLF score. Each lung was divided into 5 lobes (right upper, right middle, right lower, left upper, left lower). For the quantitative HRCT analyses, a computer read the images and quantified the percent (%) and volume (mL) of fibrosis for the whole lung by averaging the scores from each of 5 lung lobes. Baseline was defined as the Screening evaluation. Missing data were imputed using the multiple imputation (MI) method to handle missing values.

    Measured: Baseline (Screening), Week 24 and Week 48

  2. Number of Participants With IPF Progression Events up to Week 48

    IPF progression events included death from any cause or absolute decline in FVC (% predicted) value of ≥10%, confirmed by repeat spirometry. Classification of FVC (% predicted) declined ≥10% was based on observed and imputed data. Missing data in FVC (% predicted) were imputed using the predicted values from the random coefficient module with treatment, visit, visit-by-treatment interaction, and Baseline FVC (% predicted) as fixed effects and linear slope as random effect.

    Measured: Baseline (Screening and Day 1) up to Week 48

  3. Mean Change From Baseline in the Health-Related Quality of Life (HRQoL) Saint George's Respiratory Questionnaire (SGRQ) Domain and Total Scores to Week 24 and Week 48

    HRQoL was assessed by the SGRQ to measure health impairment, and includes 17 questions in 3 domains: Symptoms, Activity and Impacts. The domain and total scores range from 0 to 100, with 0 indicating the best and 100 indicating the worst possible health status. Missing data at post-baseline visits were imputed as the predicted values from the random coefficient model which included treatment, visit, visit-by-treatment interaction, and Baseline SGRQ score as fixed effects and linear slope of visit as random effect.

    Measured: Baseline (Day 1), Week 24 and Week 48

  4. Number of Participants With a Respiratory-Related Hospitalization

    Respiratory-related hospitalizations were reported by participants and recorded by the Investigators.

    Measured: Week 55

  5. Number of Participants With a Respiratory-Related Death

    Investigators determined whether a death was respiratory-related.

    Measured: Week 55

  6. Number of Participants With No Decline in FVC (% Predicted) at Week 48

    FVC in liters was measured during the spirometry assessments. The FVC (% predicted) was calculated for the corresponding gender-race-age group. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Classification of 'No decline' is based on observed and imputed data. Missing data in FVC (% predicted) are imputed using the predicted values from the random coefficient model with treatment, visit, visit-by-treatment interaction, and Baseline FVC (% predicted) as fixed effects and linear slope of visit as random effect.

    Measured: Baseline (Day 1) to Week 48.

Timeline

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

  1. First posted1 Jul 2013 (estimated)
  2. Study start30 Jul 2013
  3. Primary completion16 Nov 2017
  4. Study completion16 Nov 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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01890265
Sponsor's protocol ID
FGCL-3019-067
Status last verified
Aug 2020
First submitted
24 Jun 2013
Last updated
4 Sep 2020
Data monitoring committee
Yes

Publications

  • Lipson KE, Wong C, Teng Y, Spong S. CTGF is a central mediator of tissue remodeling and fibrosis and its inhibition can reverse the process of fibrosis. Fibrogenesis Tissue Repair. 2012 Jun 6;5(Suppl 1):S24. doi: 10.1186/1755-1536-5-S1-S24. eCollection 2012.

    PubMed 23259531

  • 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

  • Richeldi L, Fernandez Perez ER, Costabel U, Albera C, Lederer DJ, Flaherty KR, Ettinger N, Perez R, Scholand MB, Goldin J, Peony Yu KH, Neff T, Porter S, Zhong M, Gorina E, Kouchakji E, Raghu G. Pamrevlumab, an anti-connective tissue growth factor therapy, for idiopathic pulmonary fibrosis (PRAISE): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2020 Jan;8(1):25-33. doi: 10.1016/S2213-2600(19)30262-0. Epub 2019 Sep 28.

    PubMed 31575509

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pamrevlumab, Sub-Study: Pirfenidone and Sub-Study: Nintedanib in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 42 sites in 7 countries.

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

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States, India, New Zealand, South Africa, Australia and 2 more countries. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in FVC (Percent of Predicted FVC Value [% Predicted]) to Week 48 (time frame: Baseline (Screening and Day 1), Week 48). 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 NCT01890265, which also lists 3 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 4 Sep 2020.

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