The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
544
125 mg/mL single-dose vials administered subcutaneously once a week
Simtuzumab placebo single-dose vials administered subcutaneously once a week
Progression Free Survival
Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
Time frame: Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 50th Percentile
Time frame: Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 75th Percentile
Time frame: Up to 148 weeks
Overall Survival (OS)
Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
Time frame: Up to 151 weeks
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile
Time frame: Up to 151 weeks
Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile
Time frame: Up to 151 weeks
Relative Change From Baseline in FVC % Predicted
* FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition. * Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130 * The relative change was calculated as 100% \* ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
The University of Arizona
Tucson, Arizona, United States
University of California San Diego
La Jolla, California, United States
David Geffen School of Medicine at University of California, Los Angeles
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
...and 165 more locations
Time frame: Weeks 54, 106, and 130
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Time frame: Up to 148 weeks
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Time frame: Up to 148 weeks
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Time frame: Up to 148 weeks
Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
* Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130. * The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Time frame: Weeks 58, 106, and 130
Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
* The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations. * The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Time frame: Week 58, 106, and 130