The purpose of this study is to determine if study drug (BMS-986020) dose of 600 mg once daily or 600 mg twice daily for 26 weeks compared with placebo will reduce the decline in forced vital capacity (FVC) and will be well tolerated in subjects with idiopathic pulmonary fibrosis (IPF).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
325
Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26
FVC is the is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of the lungs after taking an inhaled bronchodilator medicine which is used to dilate participant's bronchial (breathing) tubes.
Time frame: Baseline, Week 26
Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline
The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller geometric mean ratios to baseline were considered favorable. Baseline included all testing done on Day -1 as well as predose on Day 1.
Time frame: Baseline, Week 26
Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26
The 6MWT measures the distance (in meters), a participant is able to walk in 6 minutes. This test measures the distance a person can walk quickly on a flat, hard surface in 6 minutes and reflects an individual's ability to perform daily physical activities. Baseline included all testing done on Day -1 as well as predose on Day 1
Time frame: Baseline, Week 26
Mean Change From Baseline in the University of California at San Diego Shortness of Breath Questionnaire (UCSD SOBQ) Total Score as a Measure of Dyspnea to Week 26
The UCSD SOBQ is a 24-item questionnaire developed to measure breathlessness on a scale between zero and five where 0 is not at all breathless and 5 is maximally breathless or too breathless to do the activity. Baseline included all testing done on Day -1 as well as predose on Day 1. The total score ranges from 0 to 120, with higher scores indicating worse dyspnea.
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University of Alabama at Birmingham - Division of Pulmonary, Allergy & Criticial Care
Birmingham, Alabama, United States
St. Joseph's Hospital and Medical Center - Heart Lung Institute/ Clinical Research
Phoenix, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine, Section of Pulmonary & Critical Care
New Haven, Connecticut, United States
Advanced Pulmonary & Sleep Research Institute of Florida
Daytona Beach, Florida, United States
University of Florida
Gainesville, Florida, United States
...and 62 more locations
Time frame: Baseline, Week 26
Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26
FVC is is the total amount of air exhaled during the forced expiratory volume test that is measured during spirometry; and is the most important measurement of lung function. This test requires participant to breath into a tube connected to a machine that measures the amount of air that can be moved in and out of lungs after taking an inhaled bronchodilator medicine which is used to dilate bronchial (breathing) tubes. Baseline included all testing done on Day -1 as well as predose on Day 1
Time frame: Baseline, Week 26
Mean Change From Baseline in Quality of Life as Measured by the Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36) to Week 26
The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the Aggregate Physical score of the SF-36. Items 5-8 primarily contribute to the Aggregate mental score of the SF-36. Scores on each item are summed and averaged. Range for Aggregate Physical Score : 0=worst to 100=best; and for Aggregate Mental Score: 0=worst to 100=best. Increases from baseline indicate improvement. Baseline included all testing done on Day -1 as well as predose on Day 1
Time frame: Baseline, Week 26
Number of Participants With Death or Non-Elective Hospitalization
Time to death or non-elective hospitalization was defined as the elapsed time (days) from randomization to the date of death or the first non-elective hospitalization.
Time frame: Upto Day 210
Number of Participants With Death or Respiratory Hospitalization or 10 Percent (%) Decline in Absolute Volume of FVC or 25-Meter Loss in 6-Minute Walk Distance (6MWD)
Number of participants with death or respiratory hospitalization or 10% decline in absolute volume of FVC or 25 meter loss in 6MWD over time were reported.
Time frame: Upto Day 210
Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26
DLCO is a measurement of the ability of the lungs to transfer gases from the air to the blood. Participant breathe in (inhale) air containing a very small, harmless amount of a tracer gas, such as carbon monoxide. Participant hold the breath for 10 seconds, then rapidly blow it out (exhale). The exhaled gas was tested to determine how much of the tracer gas was absorbed during the breath. DLCO, both uncorrected and corrected for hemoglobin in milliliter per minute per millimeter of mercury (mL/min/mmHg) was assessed.
Time frame: Baseline, Week 26
Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF)
Acute IPF exacerbations is defined as a clinically significant deterioration of unidentifiable cause in a participant with underlying IPF. Exacerbations of IPF were adjudicated as definite (\>=1 AEx) and Probable. Investigators were asked to make the diagnosis of acute exacerbation of IPF on the basis of subjective worsening over 30 days or less, new bilateral radiographic opacities, and the absence of infection or another identifiable etiology. The final diagnosis, however, was confirmed by the study medical monitor.
Time frame: Upto Day 210
Maximum Observed Plasma Concentration (Cmax) BMS-986020
Cmax is defined as the maximum observed plasma concentration.
Time frame: Day 1 and Day 7
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020
Tmax is defined as the maximum observed plasma concentration.
Time frame: Day 1 and Day 7
Accumulation Index (AI) of BMS-986020
AI is the ratio of area under the concentration time curve in one dosing interval in (AUC\[TAU\]) at steady-state to AUC(TAU) after the first dose.
Time frame: Day 7
Area Under the Concentration Time Curve in One Dosing Interval of BMS -986020 in at Steady-state
AUC(TAU) is the area under the concentration time curve in one dosing interval in at steady-state.
Time frame: Day 1 and Day 7
Area Under the Plasma Concentration-time Curve Over 12 Hours Post-dose AUC(0-12) of BMS -986020
AUC(0-12) is the area under the plasma concentration time curve over 12 hours post-dose.
Time frame: Day 1 and Day 7
Apparent Oral Clearance (CLF/F) of BMS -986020
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: Day 1 and Day 7
Average Concentration of BMS -986020 at Steady State (Css[Avg])
Css (avg) is the average concentration at steady state.
Time frame: Day 7