Evaluation of Efficacy and Safety of Pamrevlumab in Patients With Idiopathic Pulmonary Fibrosis

Study Purpose

This is a Phase 3 trial to evaluate the efficacy and safety of 30 mg/kg intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in subjects with Idiopathic Pulmonary Fibrosis

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation. 2. HRCT scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing. 3. FVCpp value >45% and <95% 4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90% at screening (determined locally). 5. Not currently receiving treatment for IPF with an approved therapy (i.e., pirfenidone or nintedanib) for any reason, including prior intolerance to an approved IPF therapy. Key

Exclusion Criteria:

1. Previous exposure to pamrevlumab. 2. Evidence of significant obstructive lung disease. 3. Female subjects who are pregnant or nursing. 4. Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study. 5. Interstitial lung disease other than IPF. 6. Sustained improvement in the severity of IPF. 7. Other types of respiratory diseases including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall. 8. Certain medical conditions, including recent (e.g. MI/stroke, or severe chronic heart failure or pulmonary hypertension, or cancers. 9. Acute IPF exacerbation during Screening or Randomization. 10. Recent use of any investigational drugs or unapproved therapies, or approved or participation in any clinical trial. 11. History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03955146
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

FibroGen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Argentina, Australia, Chile, Hong Kong, Korea, Republic of, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab in subjects with idiopathic pulmonary fibrosis (IPF). Subjects who are not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) may be eligible for screening. Examples of reasons subjects may not be treated with approved IPF therapies include but are not limited to:

  • - Intolerant or not responsive to approved IPF therapies - Ineligible to receive these therapies - Subject voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks NOTE: No subject should discontinue an approved IPF therapy for the purpose of enrolling in this study.
Approximately 340 eligible subjects will be randomized at a 1:1 ratio to Arm A or Arm B, respectively: Arm A: pamrevlumab, 30 mg/kg IV, Day 1 and every 3 weeks thereafter Arm B: Matching placebo IV, Day 1 and every 3 weeks thereafter The study consists of the following study periods:
  • - Main (double blind, placebo-controlled) phase: - Screening period: Up to 6 weeks - Treatment period: 48 weeks - Optional, open label extension (OLE) phase of pamrevlumab: o Access to pamrevlumab will be available until the last subject completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first.
  • - Follow-up period/final safety assessments: - 28 days after last dose - 60 days after last dose: follow-up phone call, for a final safety assessment During the treatment period, co-administration of an approved IPF therapy (i.e., pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment.
Subjects who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments. Subjects who complete the study will be eligible for an open-label, extension with pamrevlumab.

Arms & Interventions

Arms

Experimental: Pamrevlumab

Experimental: Placebo

Interventions

Drug: - Pamrevlumab

Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks

Drug: - Placebo

Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Center, Birmingham, Alabama

Status

Recruiting

Address

Research Center

Birmingham, Alabama, 35294

Research Center, Phoenix, Arizona

Status

Recruiting

Address

Research Center

Phoenix, Arizona, 85032

Research Center, Conway, Arkansas

Status

Recruiting

Address

Research Center

Conway, Arkansas, 72032

Research Center, Denver, Colorado

Status

Recruiting

Address

Research Center

Denver, Colorado, 80206

Research Center, Clearwater, Florida

Status

Recruiting

Address

Research Center

Clearwater, Florida, 33765

Research Center, Gainesville, Florida

Status

Recruiting

Address

Research Center

Gainesville, Florida, 32610

Research Center, Jacksonville, Florida

Status

Recruiting

Address

Research Center

Jacksonville, Florida, 32209

Research Center, Jacksonville, Florida

Status

Recruiting

Address

Research Center

Jacksonville, Florida, 32224

Research Center, Kissimmee, Florida

Status

Recruiting

Address

Research Center

Kissimmee, Florida, 34741

Research Center, Atlanta, Georgia

Status

Recruiting

Address

Research Center

Atlanta, Georgia, 30322

Research Center, Austell, Georgia

Status

Recruiting

Address

Research Center

Austell, Georgia, 30106

Research Center, Chicago, Illinois

Status

Recruiting

Address

Research Center

Chicago, Illinois, 60611

Research Center, Maywood, Illinois

Status

Recruiting

Address

Research Center

Maywood, Illinois, 60153

Research Center, Indianapolis, Indiana

Status

Recruiting

Address

Research Center

Indianapolis, Indiana, 46202

Research Center, Kansas City, Kansas

Status

Recruiting

Address

Research Center

Kansas City, Kansas, 66160

Research Center, Louisville, Kentucky

Status

Recruiting

Address

Research Center

Louisville, Kentucky, 40292

Research Center, Baltimore, Maryland

Status

Recruiting

Address

Research Center

Baltimore, Maryland, 21201

Research Center, Minneapolis, Minnesota

Status

Recruiting

Address

Research Center

Minneapolis, Minnesota, 55455

Research Center, Chesterfield, Missouri

Status

Recruiting

Address

Research Center

Chesterfield, Missouri, 63017

Research Center, Lebanon, New Hampshire

Status

Recruiting

Address

Research Center

Lebanon, New Hampshire, 03756

Research Center, Albany, New York

Status

Recruiting

Address

Research Center

Albany, New York, 12208

Research Center, Greensboro, North Carolina

Status

Recruiting

Address

Research Center

Greensboro, North Carolina, 27403

Research Center, Cincinnati, Ohio

Status

Recruiting

Address

Research Center

Cincinnati, Ohio, 45267

Research Center, Columbus, Ohio

Status

Recruiting

Address

Research Center

Columbus, Ohio, 43210

Research Center, Oklahoma City, Oklahoma

Status

Recruiting

Address

Research Center

Oklahoma City, Oklahoma, 73112

Research Center, Portland, Oregon

Status

Recruiting

Address

Research Center

Portland, Oregon, 97210

Research Center, Portland, Oregon

Status

Recruiting

Address

Research Center

Portland, Oregon, 97220

Research Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Research Center

Philadelphia, Pennsylvania, 19107

Research Center, Philadelphia, Pennsylvania

Status

Recruiting

Address

Research Center

Philadelphia, Pennsylvania, 19140

Research Center, Providence, Rhode Island

Status

Recruiting

Address

Research Center

Providence, Rhode Island, 02903

Research Center, Charleston, South Carolina

Status

Recruiting

Address

Research Center

Charleston, South Carolina, 29406

Research Center, Charleston, South Carolina

Status

Recruiting

Address

Research Center

Charleston, South Carolina, 29425

Research Center, Hendersonville, Tennessee

Status

Recruiting

Address

Research Center

Hendersonville, Tennessee, 37075

Research Center, Nashville, Tennessee

Status

Recruiting

Address

Research Center

Nashville, Tennessee, 37232

Research Center, Cypress, Texas

Status

Recruiting

Address

Research Center

Cypress, Texas, 77429

Research Center, Dallas, Texas

Status

Recruiting

Address

Research Center

Dallas, Texas, 75246

Research Center, Dallas, Texas

Status

Recruiting

Address

Research Center

Dallas, Texas, 75390

Research Center, Houston, Texas

Status

Recruiting

Address

Research Center

Houston, Texas, 77030

Research Center, The Woodlands, Texas

Status

Recruiting

Address

Research Center

The Woodlands, Texas, 77380

Research Center, Burlington, Vermont

Status

Recruiting

Address

Research Center

Burlington, Vermont, 05405

Research Center, Milwaukee, Wisconsin

Status

Recruiting

Address

Research Center

Milwaukee, Wisconsin, 53226

International Sites

Research Center, Bahia Blanca, Buenos Aires, Argentina

Status

Recruiting

Address

Research Center

Bahia Blanca, Buenos Aires, B8000AAK

Research Center, Ciudad Autonoma De Buenos Aires (caba), Buenos Aires, Argentina

Status

Recruiting

Address

Research Center

Ciudad Autonoma De Buenos Aires (caba), Buenos Aires, 1426

Research Center, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Status

Recruiting

Address

Research Center

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1027AAP

Research Center, Florida, Buenos Aires, Argentina

Status

Recruiting

Address

Research Center

Florida, Buenos Aires, B1602DQD

Research Center, La Plata, Buenos Aires, Argentina

Status

Recruiting

Address

Research Center

La Plata, Buenos Aires, 1900

Research Center, Mar del Plata, Buenos Aires, Argentina

Status

Recruiting

Address

Research Center

Mar del Plata, Buenos Aires, B7602DCK

Research Center, Ciudad de Mendoza, Mendoza, Argentina

Status

Recruiting

Address

Research Center

Ciudad de Mendoza, Mendoza, M5500CCG

Research Center, Godoy Cruz, Provincia De Mendoza, Argentina

Status

Recruiting

Address

Research Center

Godoy Cruz, Provincia De Mendoza, M5501GCA

Research Center, San Miguel De Tucumán, Tucumán, Argentina

Status

Recruiting

Address

Research Center

San Miguel De Tucumán, Tucumán, T4000IAR

Research Center, Concord, New South Wales, Australia

Status

Recruiting

Address

Research Center

Concord, New South Wales, 2139

Research Center, Westmead, New South Wales, Australia

Status

Recruiting

Address

Research Center

Westmead, New South Wales, 2145

Research Center, South Brisbane, Queensland, Australia

Status

Recruiting

Address

Research Center

South Brisbane, Queensland, 4101

Research Center, Woolloongabba, Queensland, Australia

Status

Recruiting

Address

Research Center

Woolloongabba, Queensland, 4102

Research Center, Vina del Mar, Region De Valparaiso, Chile

Status

Recruiting

Address

Research Center

Vina del Mar, Region De Valparaiso, 2520997

Research Center, Central, Hong Kong

Status

Active, not recruiting

Address

Research Center

Central, ,

Research Center, Bucheon-si, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Research Center

Bucheon-si, Gyeonggi-do, 14584

Research Center, Incheon, Korea, Republic of

Status

Recruiting

Address

Research Center

Incheon, , 21565

Research Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Research Center

Seoul, , 2841

Research Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Research Center

Seoul, , 3080

Research Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Research Center

Seoul, , 5505

Research Center, Douliu, Yunlin County, Taiwan

Status

Recruiting

Address

Research Center

Douliu, Yunlin County, 640

Research Center, Taipei city, Zhongzheng District, Taiwan

Status

Recruiting

Address

Research Center

Taipei city, Zhongzheng District, 10002

Research Center, Taichung, Taiwan

Status

Recruiting

Address

Research Center

Taichung, , 40201

Research Center, Taichung, Taiwan

Status

Recruiting

Address

Research Center

Taichung, , 40705

Research Center, Taipei, Taiwan

Status

Recruiting

Address

Research Center

Taipei, ,

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