A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.

Time frame: From baseline (first dose) up to week 26

Population: All treated participants in the IPF Cohort with baseline and week 26 results. Prespecified to be collected for IPF Cohort only.

Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. The absolute change in FVC (mL) is measured from baseline up to Weeks 4, 8, 12, 16, 20, and 26.

Time frame: From baseline up to Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with FVC data at Weeks 4, 8, 12, 16, 20, and 26

The absolute change in ppFVC (%) is measured from baseline up to the pre-specified timepoints of Weeks 4, 8, 12, 16, 20, and 26. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air (mL) exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.

Time frame: From baseline up to Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with ppFVC data at Weeks 4, 8, 12, 16, 20, and 26

The absolute change in percent predicted single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.

Time frame: From baseline up to Week 26

Population: All treated participants with ppDLCO SB data at Week 26

The absolute change in single breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26. DLCO is defined as a measurement of the extent to which oxygen passes from the alveoli into the blood. Baseline is defined as first dose.

Time frame: From baseline up to Week 26

Population: All treated participants with DLCO SB data at Week 26

The absolute change in walking endurance/distance as determined by the 6-minute walk test (6MWT) from baseline to Week 26. The 6-Minute Walk Test (6MWT) is a submaximal exercise test used to assess aerobic capacity and endurance. Baseline is defined as first dose.

Time frame: From baseline up to Week 26

Population: All participants with evaluable 6MWT data at Week 26

Area under the plasma concentration-time curve (AUC) from the timepoint of 0 hours to 24 hours post dose as measured on Day 1 and Week 4.

Time frame: On Day 1 and Week 4 (Day 29)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data

Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for PF-ILD cohort only as pre-specified in the protocol.

Time frame: At baseline and Week 26

Population: All treated participants in the PF-ILD Cohort with baseline and week 26 results. Pre-specified to be collected for PF-ILD Cohort only.

The change from baseline in select vital sign measurements. Baseline is defined as first dose.

Time frame: At baseline and Week 26

Population: All treated participants with baseline and week 26 vital sign measurement results.

Ctrough is defined as the lowerst concentration of drug in the blood immediately before the next dose is administered

Time frame: On Week 4 (Day 29) and Week 12 (Day 85)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data

Cmax is defined as the maximum concentration of the analyte recorded in the participants. Cmax of BMS-986278 and BMT-327319 was derived from plasma concentration versus time data.

Time frame: On Day 1 and Week 4 (Day 29)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data

The number of participants experiencing acute exacerbations of lung fibrosis. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: 1. Acute worsening or development of dyspnea (\< 1 month duration) 2. Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia 3. Respiratory deterioration not fully explained by cardiac failure or fluid overload

Time frame: From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first

Population: All treated participants

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

Time frame: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

The number of participants who discontinued study treatment due to adverse events (AEs)

Time frame: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

A frequency summary of investigator clinical interpretation of ECG abnormal findings is listed.

Time frame: At Week 26

Population: All treated participants

A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.

Time frame: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

The number of participants who died while receiving study treatment due to an adverse event

Time frame: From first dose up to 30 days after last dose during the main study treatment phase

Population: All treated participants

The number of participants with 0% change in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.

Time frame: Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with ppFVC data at the prespecified timepoints Weeks 4, 8, 12, 16, 20, and 26.

The number of participants with ≥ 10% absolute decline in percent predicted forced vital capacity (ppFVC) at pre-specified timepoints. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant. The number of participants represented signify the number of participants with applicable data during the specific visit at the specific timepoint.

Time frame: At Weeks 4, 8, 12, 16, 20, and 26

Population: All treated participants with ppFVC data during visits at the specific time windows of Weeks 4, 8, 12, 16, 20, and 26.

Time to first acute exacerbations of lung fibrosis was measured from the day of first dose up to the day of first acute exacerbation. Participants who discontinued the study treatment prior to the end of the main study without experiencing the event were excluded from the analysis. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinued study without event, or at week 26 if a participant did not experience the event until the end of week 26. Acute exacerbations were defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality, as follows: 1. Acute worsening or development of dyspnea (\< 1 month duration) 2. Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia 3. Respiratory deterioration not fully explained by cardiac failure or fluid overload

Time frame: From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first

Population: All participants who experienced acute exacerbation

The amount of time in weeks to the participant's first occurrence ≥ 10% absolute decline in Percent Predicted Forced Vital Capacity (ppFVC). A participant's time is censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26. Kaplan-Meier product limit method will be employed to estimate the survival curves. ppFVC is the maximum capacity of air that a participant can exhale after a maximum inspiration. It measures the volume of air exhaled in a spirometer, after a maximal inspiration. It is reported as the percentage of the predicted value for the participant.

Time frame: From first dose up to the first occurrence of ≥ 10% absolute decline in ppFVC

Population: The total accumulated number of participants with ≥ 10% Absolute Decline in ppFVC events at any time from first dose up to Week 26. A participant's time was censored at the last observed time prior to discontinuation if a participant discontinues study without event, or at week 26 if a participant does not experience the event until the end of week 26.

Tmax is defined as the amount of time until the maximum concentration of the analyte is recorded in the participants

Time frame: On Day 1 and Week 4 (Day 29)

Population: All randomized participants who received at least one administration of BMS-986278 and had quantifiable concentration data