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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04308681
Registration number
NCT04308681
Ethics application status
Date submitted
12/03/2020
Date registered
16/03/2020
Date last updated
24/02/2025
Titles & IDs
Public title
A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis
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Scientific title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and the Safety and Tolerability of BMS-986278 in Participants With Pulmonary Fibrosis
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Secondary ID [1]
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2019-003992-21
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Secondary ID [2]
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IM027-040
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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0
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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0
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Connective tissue diseases
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BMS-986278 Placebo
Treatment: Drugs - BMS-986278
Experimental: IPF Dose 1 + Post Treatment Follow-up or OTE - IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
Experimental: IPF Dose 2 + Post Treatment Follow-up or OTE -
Placebo comparator: IPF Placebo + Post Treatment Follow-up or OTE -
Experimental: PF-ILD Dose 1 + Post Treatment Follow-up or OTE - PF-ILD (Progressive Fibrotic Interstitial Lung Disease)
Experimental: PF-ILD Dose 2 + Post Treatment Follow-up or OTE -
Placebo comparator: PF-ILD Placebo + Post Treatment Follow-up or OTE -
Other interventions: BMS-986278 Placebo
Specified Dose on Specified Days
Treatment: Drugs: BMS-986278
Specified Dose on Specified Days
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants
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Assessment method [1]
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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.
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Timepoint [1]
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From baseline (first dose) up to week 26
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Secondary outcome [1]
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The Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose up to 30 days after last dose during the main study treatment phase
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Secondary outcome [2]
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The Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose up to 30 days after last dose during the main study treatment phase
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Secondary outcome [3]
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The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
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Assessment method [3]
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The number of participants who discontinued study treatment due to adverse events (AEs)
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Timepoint [3]
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From first dose up to 30 days after last dose during the main study treatment phase
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Secondary outcome [4]
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The Number of Participants Who Died Due to Adverse Events (AEs)
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Assessment method [4]
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The number of participants who died while receiving study treatment due to an adverse event
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Timepoint [4]
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From first dose up to 30 days after last dose during the main study treatment phase
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Secondary outcome [5]
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Maximum Concentration (Cmax)
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Assessment method [5]
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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.
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Timepoint [5]
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On Day 1 and Week 4 (Day 29)
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Secondary outcome [6]
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Time to Maximum Concentration (Tmax)
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Assessment method [6]
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Tmax is defined as the amount of time until the maximum concentration of the analyte is recorded in the participants
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Timepoint [6]
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On Day 1 and Week 4 (Day 29)
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Secondary outcome [7]
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Area Under Curve (AUC0-8)
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Assessment method [7]
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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.
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Timepoint [7]
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On Day 1 and Week 4 (Day 29)
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Secondary outcome [8]
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Concentration Trough (Ctrough)
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Assessment method [8]
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Ctrough is defined as the lowerst concentration of drug in the blood immediately before the next dose is administered
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Timepoint [8]
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On Week 4 (Day 29) and Week 12 (Day 85)
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Secondary outcome [9]
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The Number of Participants Experiencing Electrocardiogram (ECG) Abnormalities
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Assessment method [9]
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A frequency summary of investigator clinical interpretation of ECG abnormal findings is listed.
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Timepoint [9]
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At Week 26
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Secondary outcome [10]
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Change From Baseline in Vital Sign Measurements
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Assessment method [10]
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The change from baseline in select vital sign measurements. Baseline is defined as first dose.
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Timepoint [10]
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At baseline and Week 26
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Secondary outcome [11]
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Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in PF-ILD Participants
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Assessment method [11]
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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.
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Timepoint [11]
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At baseline and Week 26
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Secondary outcome [12]
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The Number of Participants With = 10% Absolute Decline in ppFVC (%)
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Assessment method [12]
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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.
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Timepoint [12]
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At Weeks 4, 8, 12, 16, 20, and 26
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Secondary outcome [13]
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The Number of Participants With 0% Change in ppFVC (%)
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Assessment method [13]
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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.
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Timepoint [13]
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Weeks 4, 8, 12, 16, 20, and 26
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Secondary outcome [14]
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Time to First Occurrence = 10% Absolute Decline in ppFVC (%)
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Assessment method [14]
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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.
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Timepoint [14]
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From first dose up to the first occurrence of = 10% absolute decline in ppFVC
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Secondary outcome [15]
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Absolute Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC)
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Assessment method [15]
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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.
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Timepoint [15]
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From baseline up to Weeks 4, 8, 12, 16, 20, and 26
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Secondary outcome [16]
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Absolute Change From Baseline in Forced Vital Capacity (FVC)
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Assessment method [16]
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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.
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Timepoint [16]
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From baseline up to Weeks 4, 8, 12, 16, 20, and 26
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Secondary outcome [17]
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Absolute Change From Baseline in Single Breath Diffusing Capacity of Carbon Monoxide (DLCO SB)
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Assessment method [17]
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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.
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Timepoint [17]
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From baseline up to Week 26
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Secondary outcome [18]
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Absolute Change From Baseline in Percent Predicted Single Breath Diffusing Capacity of Carbon Monoxide (ppDLCO SB)
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Assessment method [18]
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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.
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Timepoint [18]
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From baseline up to Week 26
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Secondary outcome [19]
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Absolute Change From Baseline in Walking Endurance/Distance
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Assessment method [19]
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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.
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Timepoint [19]
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From baseline up to Week 26
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Secondary outcome [20]
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Time to First Acute Exacerbation
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Assessment method [20]
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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
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Timepoint [20]
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From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
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Secondary outcome [21]
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The Number of Participants Experiencing Acute Exacerbation
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Assessment method [21]
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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
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Timepoint [21]
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From the first dose up to the day of the first acute exacerbation or Week 26, whichever comes first
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Eligibility
Key inclusion criteria
For the idiopathic pulmonary fibrosis (IPF) Cohort
* Diagnosis of IPF within 7 years of screening
* Female and males = 40 years of age
For the progressive fibrotic interstitial lung disease (PF-ILD) Cohort
* Evidence of progressive ILD within the 24 months before screening
* Female and male = 21 years of age.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Women of childbearing potential (WOCBP)
* Active Smokers
* Current malignancy or previous malignancy up to 5 years prior to screening
* History of allergy to BMS-986278 or related compounds
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/09/2023
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Sample size
Target
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Accrual to date
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Final
403
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0045 - Camperdown
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Recruitment hospital [2]
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Local Institution - 0025 - Westmead
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Recruitment hospital [3]
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Local Institution - 0026 - Brisbane
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Recruitment hospital [4]
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Local Institution - 0046 - Greenslopes
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Recruitment hospital [5]
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Local Institution - 0022 - Adelaide
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Recruitment hospital [6]
0
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Local Institution - 0023 - Heidelberg
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Recruitment hospital [7]
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Local Institution - 0021 - Murdoch
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Recruitment hospital [8]
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Local Institution - 0044 - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4032 - Brisbane
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Recruitment postcode(s) [4]
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4120 - Greenslopes
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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6150 - Murdoch
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Recruitment postcode(s) [8]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
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Arizona
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0
0
United States of America
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California
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0
0
United States of America
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0
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Colorado
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0
0
United States of America
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0
0
Connecticut
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0
0
United States of America
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0
0
Florida
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0
0
United States of America
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State/province [7]
0
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Georgia
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0
0
United States of America
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State/province [8]
0
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Kansas
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0
0
United States of America
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State/province [9]
0
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Maryland
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0
0
United States of America
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0
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Massachusetts
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0
0
United States of America
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0
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Missouri
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0
0
United States of America
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Ohio
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0
0
United States of America
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Pennsylvania
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0
0
United States of America
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Tennessee
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0
0
United States of America
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Virginia
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0
0
Argentina
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State/province [16]
0
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Distrito Federal
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0
0
Argentina
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0
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Santa FE
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0
0
Argentina
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0
0
Tucuman
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0
0
Argentina
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0
0
Buenos AIres
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0
0
Argentina
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0
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Buenos Aires
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0
0
Argentina
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0
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Mendoza
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0
0
Belgium
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0
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Brussels
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0
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Belgium
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0
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Leuven
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0
0
Belgium
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State/province [24]
0
0
Liège
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0
0
Brazil
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State/province [25]
0
0
RIO Grande DO SUL
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Country [26]
0
0
Brazil
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0
0
SAO Paulo
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0
0
Brazil
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0
Sao Paulo
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0
0
Canada
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0
0
British Columbia
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0
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Canada
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0
0
Ontario
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0
0
Canada
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0
0
Quebec
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0
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Chile
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Maule
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Chile
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Valparaiso
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0
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China
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Beijing
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China
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Hubei
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0
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China
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Shanghai
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0
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France
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Bobigny
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0
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France
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0
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Bron
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0
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France
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Dijon
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0
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France
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Marseille
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0
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France
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Paris
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0
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France
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0
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Rennes
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0
0
France
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0
Toulouse
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0
0
Germany
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0
0
Niedersachsen
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0
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Germany
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0
0
Essen
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0
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Germany
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0
0
Freiburg
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0
0
Germany
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0
Grosshansdorf
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0
0
Germany
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0
0
Heidelberg
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0
0
Germany
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0
0
Munich
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0
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Germany
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0
0
Stuttgart
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0
0
Israel
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Tel-Aviv
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0
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Israel
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0
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Haifa
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0
0
Israel
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0
0
Jerusalem
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0
0
Israel
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0
0
Petah Tikva
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0
0
Israel
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0
0
Ramat Gan
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Country [55]
0
0
Italy
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0
0
Catania
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Country [56]
0
0
Italy
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State/province [56]
0
0
Modena
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Country [57]
0
0
Italy
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State/province [57]
0
0
Monza
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0
0
Italy
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0
0
Roma
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0
0
Japan
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State/province [59]
0
0
Aichi
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Country [60]
0
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Japan
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Saitama
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Funding & Sponsors
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Commercial sector/industry
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Name
Bristol-Myers Squibb
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Summary
Brief summary
The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.
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Trial website
https://clinicaltrials.gov/study/NCT04308681
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Trial related presentations / publications
Corte TJ, Lancaster L, Swigris JJ, Maher TM, Goldin JG, Palmer SM, Suda T, Ogura T, Minnich A, Zhan X, Tirucherai GS, Elpers B, Xiao H, Watanabe H, Smith RA, Charles ED, Fischer A. Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrotic interstitial lung disease (PF-ILD). BMJ Open Respir Res. 2021 Dec;8(1):e001026. doi: 10.1136/bmjresp-2021-001026. Cheng PTW, Kaltenbach RF 3rd, Zhang H, Shi J, Tao S, Li J, Kennedy LJ, Walker SJ, Shi Y, Wang Y, Dhanusu S, Reddigunta R, Kumaravel S, Jusuf S, Smith D, Krishnananthan S, Li J, Wang T, Heiry R, Sum CS, Kalinowski SS, Hung CP, Chu CH, Azzara AV, Ziegler M, Burns L, Zinker BA, Boehm S, Taylor J, Sapuppo J, Mosure K, Everlof G, Guarino V, Zhang L, Yang Y, Ruan Q, Xu C, Apedo A, Traeger SC, Cvijic ME, Lentz KA, Tirucherai G, Sivaraman L, Robl J, Ellsworth BA, Rosen G, Gordon DA, Soars MG, Gill M, Murphy BJ. Discovery of an Oxycyclohexyl Acid Lysophosphatidic Acid Receptor 1 (LPA1) Antagonist BMS-986278 for the Treatment of Pulmonary Fibrotic Diseases. J Med Chem. 2021 Nov 11;64(21):15549-15581. doi: 10.1021/acs.jmedchem.1c01256. Epub 2021 Oct 28.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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No information has been provided regarding IPD availability
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Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/81/NCT04308681/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/81/NCT04308681/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04308681
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