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 ≥50% and ≤80%. 4. Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥30% and ≤90%. 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 Hong Kong, 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) over a 52 week period. 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 Screening period: Up to 6 weeks Treatment period: 48 weeks Follow-up period/final assessment: 4 weeks (Week 52 [+7 Days]) 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, Phoenix, Arizona

Status

Recruiting

Address

Research Center

Phoenix, Arizona, 85006

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, Kissimmee, Florida

Status

Recruiting

Address

Research Center

Kissimmee, Florida, 34741

Research Center, Atlanta, Georgia

Status

Recruiting

Address

Research Center

Atlanta, Georgia, 30322

Research Center, Chicago, Illinois

Status

Recruiting

Address

Research Center

Chicago, Illinois, 60611

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, 40202

Research Center, Chesterfield, Missouri

Status

Recruiting

Address

Research Center

Chesterfield, Missouri, 63017

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, Portland, Oregon

Status

Recruiting

Address

Research Center

Portland, Oregon, 97210

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, Charleston, South Carolina

Status

Recruiting

Address

Research Center

Charleston, South Carolina, 29406

Research Center, Hendersonville, Tennessee

Status

Not yet recruiting

Address

Research Center

Hendersonville, Tennessee, 37075

Research Center, Dallas, Texas

Status

Recruiting

Address

Research Center

Dallas, Texas, 75390

Research Center, The Woodlands, Texas

Status

Recruiting

Address

Research Center

The Woodlands, Texas, 77380

International Sites

Research Center, Central, Hong Kong

Status

Recruiting

Address

Research Center

Central, ,

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

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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