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.

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.

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.

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

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

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.

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

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.

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

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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 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:

• Acute worsening or development of dyspnea (< 1 month duration)
• Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia
• Respiratory deterioration not fully explained by cardiac failure or fluid overload

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:

• Acute worsening or development of dyspnea (< 1 month duration)
• Imaging with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia
• Respiratory deterioration not fully explained by cardiac failure or fluid overload