Adults 40 to 90, any sex, with Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26Primary· Baseline, 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.
Group
Value
95% CI
BMS-986020 600 mg Once Daily
-0.076
± 0.2238
BMS-986020 600 mg Twice Daily
-0.050
± 0.2440
Placebo
-0.136
± 0.1804
Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to BaselineSecondary· Baseline, Week 26
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.
Group
Value
95% CI
BMS-986020 600 mg Once Daily
1.14
BMS-986020 600 mg Twice Daily
1.09
Placebo
1.11
Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26Secondary· Baseline, 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
Group
Value
95% CI
BMS-986020 600 mg Once Daily
-14.2
± 47.85
BMS-986020 600 mg Twice Daily
6.1
± 53.87
Placebo
10.3
± 54.73
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 26Secondary· Baseline, 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.
Group
Value
95% CI
BMS-986020 600 mg Once Daily
3.8
± 17.84
BMS-986020 600 mg Twice Daily
-1.7
± 21.29
Placebo
3.9
± 18.24
Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26Secondary· Baseline, 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
Group
Value
95% CI
BMS-986020 600 mg Once Daily
-0.076
± 0.2238
BMS-986020 600 mg Twice Daily
-0.050
± 0.2440
Placebo
-0.136
± 0.1804
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 26Secondary· Baseline, 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 a
Aggregate Physical Score
Group
Value
95% CI
BMS-986020 600 mg Once Daily
-3.4
± 1.0
BMS-986020 600 mg Twice Daily
-1.0
± 1.0
Placebo
-2.1
± 1.1
Aggregate Mental Score
Group
Value
95% CI
BMS-986020 600 mg Once Daily
0.1
± 1.3
BMS-986020 600 mg Twice Daily
1.7
± 1.3
Placebo
-1.1
± 1.3
Number of Participants With Death or Non-Elective HospitalizationSecondary· Upto Day 210
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.
Group
Value
95% CI
BMS-986020 600 mg Once Daily
5
BMS-986020 600 mg Twice Daily
4
Placebo
2
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)Secondary· Upto Day 210
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.
Group
Value
95% CI
BMS-986020 600 mg Once Daily
24
BMS-986020 600 mg Twice Daily
28
Placebo
26
Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26Secondary· Baseline, 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.
Uncorrected for hemoglobin
Group
Value
95% CI
BMS-986020 600 mg Once Daily
-1.1
± 0.7
BMS-986020 600 mg Twice Daily
-0.2
± 0.7
Placebo
-1.1
± 0.7
Corrected for hemoglobin
Group
Value
95% CI
BMS-986020 600 mg Once Daily
-1.2
± 0.7
BMS-986020 600 mg Twice Daily
-0.2
± 0.7
Placebo
-1.1
± 0.7
Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF)Secondary· Upto Day 210
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.
Definite
Group
Value
95% CI
BMS-986020 600 mg Once Daily
0
BMS-986020 600 mg Twice Daily
2
Placebo
0
Probable
Group
Value
95% CI
BMS-986020 600 mg Once Daily
1
BMS-986020 600 mg Twice Daily
1
Placebo
0
Maximum Observed Plasma Concentration (Cmax) BMS-986020Secondary· Day 1 and Day 7
Cmax is defined as the maximum observed plasma concentration.
Day 1
Group
Value
95% CI
BMS-986020 600 mg Once Daily
5963.7
± 65
BMS-986020 600 mg Twice Daily
3005.8
± 104
Day 7
Group
Value
95% CI
BMS-986020 600 mg Once Daily
6535.4
± 68
BMS-986020 600 mg Twice Daily
7266.2
± 51
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020Secondary· Day 1 and Day 7
Tmax is defined as the maximum observed plasma concentration.
Day 1
Group
Value
95% CI
BMS-986020 600 mg Once Daily
3.110
1.07 – 6.00
BMS-986020 600 mg Twice Daily
2.030
1.00 – 4.00
Day 7
Group
Value
95% CI
BMS-986020 600 mg Once Daily
3.000
1.02 – 4.00
BMS-986020 600 mg Twice Daily
2.000
0.50 – 3.00
Adverse events — posted to ClinicalTrials.gov
Time frame: All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 11 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01766817.