Trial Outcomes & Findings for Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis (NCT NCT01766817)

Last Updated: 2020-08-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

325 participants

Primary outcome timeframe

Baseline, Week 26

Results posted on

2020-08-11

Participant Flow

Total 325 participants were enrolled,out of which 143 participants were randomized and treated. Reasons for not being treated were:Screening HRCT or Pulmonary function tests did not meet study criteria and "Other" reasons

Participant milestones

Participant milestones
Measure	BMS-986020 600 mg Once Daily Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Overall Study STARTED	48	48	47
Overall Study COMPLETED	37	37	34
Overall Study NOT COMPLETED	11	11	13

Reasons for withdrawal

Reasons for withdrawal
Measure	BMS-986020 600 mg Once Daily Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Overall Study Drug-related adverse event	1	2	1
Overall Study Drug-unrelated adverse event	3	3	3
Overall Study Death	1	1	0
Overall Study Unable to take study drug	0	1	0
Overall Study Withdrawal by Subject	2	0	3
Overall Study Subject non-compliance	0	1	2
Overall Study Physician Decision	3	3	4
Overall Study Other	1	0	0

Baseline Characteristics

Safety and Efficacy of a Lysophosphatidic Acid Receptor Antagonist in Idiopathic Pulmonary Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMS-986020 600 mg Once Daily n=48 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=48 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=47 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.	Total n=143 Participants Total of all reporting groups
Age, Continuous	68.4 years STANDARD_DEVIATION 6.53 • n=5 Participants	69.1 years STANDARD_DEVIATION 8.35 • n=7 Participants	69.3 years STANDARD_DEVIATION 7.57 • n=5 Participants	68.9 years STANDARD_DEVIATION 7.47 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	36 Participants n=7 Participants	33 Participants n=5 Participants	102 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants	21 Participants n=7 Participants	25 Participants n=5 Participants	70 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	27 Participants n=7 Participants	22 Participants n=5 Participants	73 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	37 Participants n=7 Participants	30 Participants n=5 Participants	101 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	27 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 26

Population: Intent-to-treat (ITT) population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=42 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=43 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=40 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Change From Baseline in Forced Vital Capacity (FVC) Rate to Week 26	-0.076 liters (L) Standard Deviation 0.2238	-0.050 liters (L) Standard Deviation 0.2440	-0.136 liters (L) Standard Deviation 0.1804

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=41 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=44 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=39 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Geometric Mean Ratio (GMR) of Quantitative Lung Fibrosis (QLF) Score at Week 26 to Baseline	1.14 Ratio	1.09 Ratio	1.11 Ratio

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.

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

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=42 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=43 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=40 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Mean Change From Baseline in Six-minute Walk Test (6MWT) Distance to Week 26	-14.2 meters (m) Standard Deviation 47.85	6.1 meters (m) Standard Deviation 53.87	10.3 meters (m) Standard Deviation 54.73

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=41 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=43 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=40 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
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	3.8 Unit on a scale Standard Deviation 17.84	-1.7 Unit on a scale Standard Deviation 21.29	3.9 Unit on a scale Standard Deviation 18.24

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for this outcome measure.

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

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=42 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=43 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=40 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Mean Change From Baseline in Forced Vital Capacity (FVC) to Week 26	-0.076 liters Standard Deviation 0.2238	-0.050 liters Standard Deviation 0.2440	-0.136 liters Standard Deviation 0.1804

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT population included all randomized participants. Here 'N' 'number of participants analyzed' signifies number of participants who were evaluable for each category.

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

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=41 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=43 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=40 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
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 Aggregate Physical Score	-3.4 Units on a scale Standard Error 1.0	-1.0 Units on a scale Standard Error 1.0	-2.1 Units on a scale Standard Error 1.1
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 Aggregate Mental Score	0.1 Units on a scale Standard Error 1.3	1.7 Units on a scale Standard Error 1.3	-1.1 Units on a scale Standard Error 1.3

SECONDARY outcome

Timeframe: Upto Day 210

Population: Safety population included all enrolled participants who received at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=48 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=48 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=47 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Number of Participants With Death or Non-Elective Hospitalization	5 Participants	4 Participants	2 Participants

SECONDARY outcome

Timeframe: Upto Day 210

Population: Safety Population included all enrolled participants who received at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=48 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=48 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=47 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
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)	24 Participants	28 Participants	26 Participants

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: ITT population included all randomized participants.Here 'n' 'number analyzed' signifies number of participants who were evaluable for each category.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=40 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=43 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=39 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26 Uncorrected for hemoglobin	-1.1 mL/min/mmHg Standard Error 0.7	-0.2 mL/min/mmHg Standard Error 0.7	-1.1 mL/min/mmHg Standard Error 0.7
Mean Change From Baseline in Carbon Monoxide Diffusing Capacity (DLCO) to Week 26 Corrected for hemoglobin	-1.2 mL/min/mmHg Standard Error 0.7	-0.2 mL/min/mmHg Standard Error 0.7	-1.1 mL/min/mmHg Standard Error 0.7

SECONDARY outcome

Timeframe: Upto Day 210

Population: ITT population included all randomized participants.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=48 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=48 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=47 Participants Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF) Definite	0 Participants	2 Participants	0 Participants
Number of Participants With Definite or Probable Acute Exacerbation (AEx) of Idiopathic Pulmonary Fibrosis (IPF) Probable	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 and Day 7

Population: Evaluable pharamcokinetic (PK) population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.

Cmax is defined as the maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=6 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=7 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Maximum Observed Plasma Concentration (Cmax) BMS-986020 Day 1	5963.7 microgram per liter (ug/L) Geometric Coefficient of Variation 65	3005.8 microgram per liter (ug/L) Geometric Coefficient of Variation 104	—
Maximum Observed Plasma Concentration (Cmax) BMS-986020 Day 7	6535.4 microgram per liter (ug/L) Geometric Coefficient of Variation 68	7266.2 microgram per liter (ug/L) Geometric Coefficient of Variation 51	—

SECONDARY outcome

Timeframe: Day 1 and Day 7

Population: Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.

Tmax is defined as the maximum observed plasma concentration.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=6 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=7 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020 Day 1	3.110 hours (h) Interval 1.07 to 6.0	2.030 hours (h) Interval 1.0 to 4.0	—
Time of Maximum Observed Plasma Concentration (Tmax) of BMS-986020 Day 7	3.000 hours (h) Interval 1.02 to 4.0	2.000 hours (h) Interval 0.5 to 3.0	—

SECONDARY outcome

Timeframe: Day 7

Population: Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable this outcome measure.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=5 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=7 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Accumulation Index (AI) of BMS-986020	1.2329 Ratio Geometric Coefficient of Variation 80	1.9386 Ratio Geometric Coefficient of Variation 97	—

SECONDARY outcome

Timeframe: Day 1 and Day 7

Population: Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.

AUC(TAU) is the area under the concentration time curve in one dosing interval in at steady-state.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=6 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=7 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Area Under the Concentration Time Curve in One Dosing Interval of BMS -986020 in at Steady-state Day 1	26921.6 ug*h/L Geometric Coefficient of Variation 69	11689.5 ug*h/L Geometric Coefficient of Variation 83	—
Area Under the Concentration Time Curve in One Dosing Interval of BMS -986020 in at Steady-state Day 7	29174.1 ug*h/L Geometric Coefficient of Variation 46	22661.8 ug*h/L Geometric Coefficient of Variation 51	—

SECONDARY outcome

Timeframe: Day 1 and Day 7

Population: Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.

AUC(0-12) is the area under the plasma concentration time curve over 12 hours post-dose.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=6 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=7 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Area Under the Plasma Concentration-time Curve Over 12 Hours Post-dose AUC(0-12) of BMS -986020 Day 1	21014.1 ug*h/L Geometric Coefficient of Variation 60	11689.5 ug*h/L Geometric Coefficient of Variation 83	—
Area Under the Plasma Concentration-time Curve Over 12 Hours Post-dose AUC(0-12) of BMS -986020 Day 7	24242.3 ug*h/L Geometric Coefficient of Variation 51	22661.8 ug*h/L Geometric Coefficient of Variation 51	—

SECONDARY outcome

Timeframe: Day 1 and Day 7

Population: Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at each time point.

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.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=6 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=7 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Apparent Oral Clearance (CLF/F) of BMS -986020 Day 1	20.272 Liter per hour (L/h) Geometric Coefficient of Variation 79	43.846 Liter per hour (L/h) Geometric Coefficient of Variation 94	—
Apparent Oral Clearance (CLF/F) of BMS -986020 Day 7	20.566 Liter per hour (L/h) Geometric Coefficient of Variation 41	26.476 Liter per hour (L/h) Geometric Coefficient of Variation 60	—

SECONDARY outcome

Timeframe: Day 7

Population: Evaluable PK population included all participants who have adequate PK profiles. Here 'n' 'number analyzed' signifies number of participants evaluable at this time point.

Css (avg) is the average concentration at steady state.

Outcome measures

Outcome measures
Measure	BMS-986020 600 mg Once Daily n=6 Participants Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=7 Participants Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Average Concentration of BMS -986020 at Steady State (Css[Avg])	1215.6 ug/L Geometric Coefficient of Variation 46	1888.5 ug/L Geometric Coefficient of Variation 51	—

Adverse Events

BMS-986020 600 mg Once Daily

Serious events: 9 serious events

Other events: 21 other events

Deaths: 2 deaths

BMS-986020 600 mg Twice Daily

Serious events: 16 serious events

Other events: 40 other events

Deaths: 2 deaths

Placebo

Serious events: 12 serious events

Other events: 25 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	BMS-986020 600 mg Once Daily n=48 participants at risk Participants received a dose of BMS-986020 300 milligram (mg) as oral tablets (each tablet of 300 mg\*2) once daily (QD), for 26 weeks.	BMS-986020 600 mg Twice Daily n=48 participants at risk Participants received a dose of BMS-986020 300 mg as oral tablets (each tablet of 300 mg\*2) twice daily (BID), for 26 weeks.	Placebo n=47 participants at risk Participants received placebo matched with BMS-986020 as oral tablets either QD or BID for 26 weeks.
Gastrointestinal disorders Abdominal pain	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.4% 3/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	4.3% 2/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	12.5% 6/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	2.1% 1/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	10.4% 5/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Bronchitis	12.5% 6/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	2.1% 1/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.4% 3/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	22.9% 11/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	12.8% 6/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Diarrhoea	8.3% 4/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	8.3% 4/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	2.1% 1/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Dizziness	2.1% 1/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	8.5% 4/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	4.3% 2/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
General disorders Fatigue	8.3% 4/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	16.7% 8/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	4.3% 2/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Gastritis	0.00% 0/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	2.1% 1/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Headache	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	16.7% 8/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	8.5% 4/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Investigations Hepatic enzyme increased	0.00% 0/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	8.3% 4/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	2.1% 1/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	10.4% 5/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	2.1% 1/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Nasopharyngitis	10.4% 5/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	8.3% 4/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	8.5% 4/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	4.3% 2/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Pharyngitis	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	2.1% 1/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	2.1% 1/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Sinusitis	4.2% 2/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.4% 3/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Investigations Transaminases increased	2.1% 1/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	0.00% 0/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.
Infections and infestations Upper respiratory tract infection	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	6.2% 3/48 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.	10.6% 5/47 • All Adverse Events were collected from signature of the informed consent until 4 weeks after last treatment administration Analysis was performed on safety population which included all enrolled participants who received at least 1 dose of study drug.