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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Fibrosis

Intervention / Treatment
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* Other: BMS-986278 Placebo
* Drug: BMS-986278


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPF Dose 1 + Post Treatment Follow-up or OTE<br>IPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension) | Drug: BMS-986278<br>* Specified Dose on Specified Days<br>|
| Experimental: IPF Dose 2 + Post Treatment Follow-up or OTE<br> | Drug: BMS-986278<br>* Specified Dose on Specified Days<br>|
| Placebo Comparator: IPF Placebo + Post Treatment Follow-up or OTE<br> | Other: BMS-986278 Placebo<br>* Specified Dose on Specified Days<br>|
| Experimental: PF-ILD Dose 1 + Post Treatment Follow-up or OTE<br>PF-ILD (Progressive Fibrotic Interstitial Lung Disease) | Drug: BMS-986278<br>* Specified Dose on Specified Days<br>|
| Experimental: PF-ILD Dose 2 + Post Treatment Follow-up or OTE<br> | Drug: BMS-986278<br>* Specified Dose on Specified Days<br>|
| Placebo Comparator: PF-ILD Placebo + Post Treatment Follow-up or OTE<br> | Other: BMS-986278 Placebo<br>* Specified Dose on Specified Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in percent predicted forced vital capacity(ppFVC) in Idiopathic Pulmonary Fibrosis (IPF) Participants |  | Up to week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | Up to 26 weeks | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 26 weeks | 
| Incidence of Adverse Events (AEs) leading to early discontinuation of study treatment |  | Up to 26 weeks | 
| Incidence of Treatment-Emergent Deaths |  | Up to 26 weeks | 
| Incidence of clinically significant changes in clinical laboratory results: Hematology tests |  | Up to 26 weeks | 
| Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests |  | Up to 26 weeks | 
| Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests |  | Up to 26 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | PR interval: The time from the onset of the P wave to the start of the QRS complex | Up to 26 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval | QRS interval: A combination of the Q wave, R wave and S wave, the QRS complex represents ventricular depolarization | Up to 26 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | QT interval: Measured from the beginning of the QRS complex to the end of the T wave | Up to 26 weeks | 
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval | QTcF interval: Corrected QT interval using Fridericia's formula (QTcF) | Up to 26 weeks | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 26 weeks | 
| Incidence of clinically significant changes in vital signs: Respiratory rate |  | Up to 26 weeks | 
| Incidence of clinically significant changes in vital signs: Blood pressure |  | Up to 26 weeks | 
| Incidence of clinically significant changes in vital signs: Heart rate |  | Up to 26 weeks | 
| Incidence of clinically significant changes in physical examination findings |  | Up to 26 weeks | 
| Rate of change in ppFVC in progressive fibrotic interstitial lung disease (PF-ILD) participants |  | Up to 26 weeks | 
| Proportion of participants with ≥ 10% absolute decline in ppFVC (%) |  | At weeks 4, 8, 12, 16, 20, and 26 | 
| Proportion of participants with > 0% change in ppFVC |  | At weeks 4, 8, 12, 16, 20, and 26 | 
| Time to first acute exacerbation |  | Up to 26 weeks | 
| Time to first ≥ 10% absolute decline in ppFVC (%) |  | Up to 26 weeks | 
| Absolute change in FVC (mL) from baseline to Week 26 |  | Up to 26 weeks | 
| Absolute change in ppFVC (%) from baseline to Week 26 |  | Up to 26 weeks | 
| Absolute change in single-breath diffusing capacity of carbon monoxide (DLCO SB) (mL/min/mmHg) (corrected for hemoglobin) from baseline to Week 26 |  | Up to 26 weeks | 
| Absolute change in ppDLCO SB (%) (corrected for hemoglobin) from baseline to Week 26 |  | Up to 26 weeks | 
| Change in walking endurance/distance from baseline at Week 26 as measured using the 6-Minute Walk Test (6MWT) |  | Up to 26 weeks | 
| Proportion of participants with acute exacerbations of lung fibrosis |  | Up to 26 weeks | 
| Maximum observed concentration (Cmax) of BMS-986278 |  | Day 1 and Week 4 | 
| Time of maximum observed concentration (Tmax) of BMS-986278 |  | Day 1 and Week 4 | 
| Area under the plasma concentration-time curve form time 0 to 8 hours post dose of BMS-986278 (AUC(0-8)) |  | Day 1 and Week 4 | 
| Trough observed plasma concentration (Ctrough) of BMS-986278 |  | Week 4 and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial lung disease, Idiopathic pulmonary fibrosis, Progressive Fibrotic Interstitial Lung Disease, Idiopathic interstitial pneumonia, Fibrotic interstitial pneumonia, Fibrotic interstitial lung disease, Fibrosing interstitial lung disease