This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.
The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants 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 * Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study. During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment. Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
372
Sterile solution for injection
Sterile solution for injection
DB Period: Change From Baseline in FVC at Week 48
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).
Time frame: Baseline, Week 48
DB Period: Time to Disease Progression
Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48
The QLF volume is calculated as QLF=total lung capacity volume (TLC) \* % of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE were analyzed using MMRM.
Time frame: Baseline, Week 48
DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First
The components of the clinical composite endpoints included acute idiopathic pulmonary fibrosis (IPF) exacerbation, respiratory hospitalization, or death. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Time to First Acute IPF Exacerbation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UAB Lung Health Center
Birmingham, Alabama, United States
UC San Francisco
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University
New Haven, Connecticut, United States
St. Francis Medical Center
Clearwater, Florida, United States
Pulmonary Disease Specialists d/b/a PDS Research
Kissimmee, Florida, United States
TGH/USF Center for Advanced Lung Disease and Lung Transplant
Tampa, Florida, United States
Emory University/The Emory Clinic
Atlanta, Georgia, United States
University of Iowa
Iowa City, Iowa, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
...and 147 more locations
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Time to All-Cause Mortality
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48
DB Period: Time to First Respiratory Hospitalization
'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.
Time frame: Up to Week 48