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

NCT01890265 | Completed Phase 2 Results DMC

• 1 other identifier: FGCL-3019-067
• Study Type: interventional
• Target: 160
• Locations: 7 countries
• Sites: 42

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis; IPF; Idiopathic Interstitial Pneumonia; Interstitial Lung Disease; Lung Fibrosis

Outcome Measures

Primary Outcomes (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.

  Baseline (Screening and Day 1), Week 48

Secondary Outcomes (6)

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

  Baseline (Screening), Week 24 and Week 48

• Number of Participants With IPF Progression Events up to Week 48

  Baseline (Screening and Day 1) up to Week 48

• 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

  Baseline (Day 1), Week 24 and Week 48

• Number of Participants With a Respiratory-Related Hospitalization

  Week 55

• Number of Participants With a Respiratory-Related Death

  Week 55

Study Arms (4)

Pamrevlumab

EXPERIMENTAL

Participants will receive pamrevlumab 30 milligram/kilogram (mg/kg) by intravenous (IV) infusion every 3 weeks for a total of 16 infusions over 45 weeks.

Drug: Pamrevlumab

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching pamrevlumab by IV infusion every 3 weeks for a total of 16 infusions over 45 weeks.

Drug: Placebo

Sub-Study: Pamrevlumab+Pirfenidone or Nintedanib

ACTIVE COMPARATOR

Participants 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.

Drug: Pamrevlumab; Drug: Sub-Study: Pirfenidone; Drug: Sub-Study: Nintedanib

Sub-Study: Placebo+Pirfenidone or Nintedanib

PLACEBO COMPARATOR

Participants 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.

Drug: Placebo; Drug: Sub-Study: Pirfenidone; Drug: Sub-Study: Nintedanib

Interventions

Pamrevlumab DRUG

Solution for infusion

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

Pamrevlumab; Sub-Study: Pamrevlumab+Pirfenidone or Nintedanib

Placebo DRUG

Solution for infusion

Placebo; Sub-Study: Placebo+Pirfenidone or Nintedanib

Sub-Study: Pirfenidone DRUG

Pirfenidone concomitant therapy will not be provided by the Sponsor.

Also known as: Esbeiet

Sub-Study: Pamrevlumab+Pirfenidone or Nintedanib; Sub-Study: Placebo+Pirfenidone or Nintedanib

Sub-Study: Nintedanib DRUG

Nintedanib concomitant therapy will not be provided by the Sponsor.

Also known as: Ofev

Sub-Study: Pamrevlumab+Pirfenidone or Nintedanib; Sub-Study: Placebo+Pirfenidone or Nintedanib

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Kyntra Bio: lead

Study Sites (42)

The Kirklin Clinic

Birmingham, Alabama, 35294, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90024, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Pulmonary Disease Specialist, PA

Kissimmee, Florida, 34741, United States

Location

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

Pensacola, Florida, 32504, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Via Christi Clinic, P.A.

Wichita, Kansas, 67208, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Steward St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

PulmonIx LLC

Greensboro, North Carolina, 27403, United States

Location

University of Cinncinati

Cincinnati, Ohio, 45267, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, Ohio, 03756, United States

Location

Legacy Research Institute

Portland, Oregon, 97210, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-5735, 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

Concord Repatriation

Concord, New South Wales, 2139, Australia

Location

Daw Park Repatriation

Adelaide, South Australia, 5041, Australia

Location

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

Sofia, 1407, Bulgaria

Location

Université de Sherbrooke / Hôpital Charles LeMoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

St Johns Medical College Hospital

Bangalore, Karnataka, 560034, India

Location

Bhatia Hospital

Mumbai, Maharashtra, 400007, India

Location

Sri Bala Medical Centre and Hospital

Coimbatore, Tamil Nadu, 641045, India

Location

Midland Healthcare & Research Center

Lucknow, Uttar Pradesh, 226006, India

Location

Fortis Hospitals

Kolkata, West Bengal, 700107, India

Location

Christchurch Hospital NZ

Christchurch, 8011, New Zealand

Location

Dunedin Public Hospital

Dunedin, 9016, New Zealand

Location

Waikato Hospital

Hamilton, 3204, New Zealand

Location

Tauranga Hospital

Tauranga, 3143, New Zealand

Location

Into Research

Pretoria, Gauteng, 0181, South Africa

Location

Life Mount Edgecombe Hospital

Durban, KwaZulu-Natal, 4068, South Africa

Location

Tygerberg Hospital Respiratory Research Unit

Cape Town, Western Cape, 7505, South Africa

Location

Related Publications (3)

• 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.

  PMID: 23259531 BACKGROUND

• 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

• 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.

  PMID: 31575509 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Idiopathic Interstitial Pneumonias; Lung Diseases, Interstitial; Pulmonary Fibrosis

Interventions

pamrevlumab; Immunoglobulin G; nintedanib

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Trial Information Desk
• Organization: FibroGen, Inc.

067study@fibrogen.com

415-978-1441

Study Officials

• Mark Wencel, M.D

  Via Christi Clinic, P.A., USA

  PRINCIPAL INVESTIGATOR

• Joao de Andrade, M.D

  The Kirklin Clinic, USA

  PRINCIPAL INVESTIGATOR

• Peter LaCamera, M.D.

  Steward St. Elizabeth's Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Danielle Antin-Ozerkis, M.D.

  Yale University, USA

  PRINCIPAL INVESTIGATOR

• Rishi Raj, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Neil Ettinger, M.D

  St Luke's Hospital, USA

  PRINCIPAL INVESTIGATOR

• Rafael Perez, M.D

  University of Louisville, USA

  PRINCIPAL INVESTIGATOR

• Timothy Albertson, M.D

  University of California Davis Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Yolanda Mageto, M.D.

  Vermont Lung Center, USA

  PRINCIPAL INVESTIGATOR

• Srihari Veeraraghavan, M.D

  Emory University, USA

  PRINCIPAL INVESTIGATOR

• Nishant Gupta, M.D

  University of Cinncinati, USA

  PRINCIPAL INVESTIGATOR

• Kevin Gibson, M.D

  University of Pittsburgh Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Lisa Lancaster, M.D.

  Vanderbilt University, USA

  PRINCIPAL INVESTIGATOR

• Mary Beth Scholand, M.D.

  University of Utah - Lung Health Research, USA

  PRINCIPAL INVESTIGATOR

• Mark Hamblin, M.D.

  University of Kansas Medical Center, USA

  PRINCIPAL INVESTIGATOR

• John Fitzgerald, M.D.

  University of Texas Southwestern Medical Center, USA

  PRINCIPAL INVESTIGATOR

• John Belperio, M.D.

  David Geffen School of Medicine at UCLA, USA

  PRINCIPAL INVESTIGATOR

• Richard Enelow, M.D.

  Dartmouth-Hitchcock Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Evans R Fernandez-Perez, M.D

  National Jewish Center, USA

  PRINCIPAL INVESTIGATOR

• Peter A Bercz, M.D

  Pensacola Research Consultants, INC., USA

  PRINCIPAL INVESTIGATOR

• Krishna Thavarajah, M.D.

  Henry Ford Medical Center, USA

  PRINCIPAL INVESTIGATOR

• James Britt, M.D.

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

• Danielle D. Hosmer

  Legacy Research Institute, USA

  PRINCIPAL INVESTIGATOR

• David Lederer, M.D.

  Columbia University Medical Center, USA

  PRINCIPAL INVESTIGATOR

• Murali Ramaswamy, M.D.

  PulmonIx LLC, USA

  PRINCIPAL INVESTIGATOR

• Thomas O'Brien, M.D.

  Pulmonary Disease Specialist, PA, USA

  PRINCIPAL INVESTIGATOR

• Nadim Srour, M.D.

  Université de Sherbrooke / Hôpital Charles LeMoyne, Canada

  PRINCIPAL INVESTIGATOR

• Elvis Irusen, M.D.

  Tygerberg Hospital Respiratory Research Unit, South Africa

  PRINCIPAL INVESTIGATOR

• Anish Ambaram, M.D.

  Life Mount Edgecombe Hospital, South Africa

  PRINCIPAL INVESTIGATOR

• Heidi Siebert, M.D.

  Into Research, South Africa

  PRINCIPAL INVESTIGATOR

• Elizabeth Veitch, M.D.

  Concord Repatriation, Australia

  PRINCIPAL INVESTIGATOR

• Huw Davies, M.D.

  Daw Park Repatriation, Australia

  PRINCIPAL INVESTIGATOR

• Lutz Beckert, M.D.

  Christchurch Hospital NZ, New Zealand

  PRINCIPAL INVESTIGATOR

• Catherina Chang, M.D.

  Waikato Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

• Benedict Brockway, M.D.

  Dunedin Public Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

• Suzanne Poole, M.D.

  Tauranga Hospital, New Zealand

  PRINCIPAL INVESTIGATOR

• Raja Dhar, M.D.

  Fortis Hospitals, India

  PRINCIPAL INVESTIGATOR

• Bhanu Singh, M.D.

  Midland Healthcare & Research Center, India

  PRINCIPAL INVESTIGATOR

• Nandagopal Velayuthaswamy, M.D.

  Sri Bala Medical Centre and Hospital, India

  PRINCIPAL INVESTIGATOR

• Sujeet Rajan, M.D.

  Bhatia Hospital, India

  PRINCIPAL INVESTIGATOR

• Priya Ramachandran, M.D.

  St Johns Medical College Hospital, India

  PRINCIPAL INVESTIGATOR

• Natalia Stoeva, M.D.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, Investigators, and study staff were blinded to treatment assignments and did not have access to the randomization codes. The high-resolution computed tomography (HRCT) readers were blinded to treatment assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: July 1, 2013
• Study Start: July 30, 2013
• Primary Completion: November 16, 2017
• Study Completion: November 16, 2017
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-08

Locations

ZA (3); NZ (4); CA (1); AU (2); IN (5); US (26); BU (1)