A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis

Phase 3Active Not RecruitingNCT06003426

Bristol-Myers Squibb1,255 enrolled

Overview

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,255

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

BMS-986278DRUG

Specified dose on specified days

BMS-986278 PlaceboDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria * Subjects with IPF aged ≥ 40 years at the time of signing the informed consent. * Diagnosis of IPF within 7 years prior to screening that is supported by centrally read chest high-resolution computed tomography (HRCT) obtained at screening and verification of usual interstitial pneumonia. * If on pirfenidone or nintedanib, participants must have been on a stable dose for at least 90 days prior to screening. * If not currently on pirfenidone or nintedanib, participants must not have received either of these medications within 28 days prior to screening. * Women who are of childbearing potential must have a highly effective form of contraception and must provide a negative urine/serum pregnancy test. * Men who are sexually active with women of childbearing potential agree to use male barrier contraception. Exclusion Criteria * History of stroke or transient ischemic attack within 3 months prior to screening. * Participants who exhibit symptoms of heart failure at rest. * Participants who have a current malignancy or a previous malignancy with less than 2 years free of recurrence or a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. * Other protocol-defined Inclusion/Exclusion criteria apply

Locations (390)

Outcomes

Primary Outcomes

Number of participants that experience spontaneous syncopal events

Cohort 1

Time frame: At approximately 4 weeks

Absolute change from baseline in forced vital capacity (FVC) measured in mL

Cohort 2

Time frame: Up to Week 52

Secondary Outcomes

Number of participants who discontinued treatment due to any low BP-related Adverse Events

Cohort 1

Time frame: Up to approximately 3 years

Disease progression

Cohort 2 Disease progression will be measured by the time to first disease progression event in at least 1 of the following parameters: * Absolute percent predicted forced vital capacity (ppFVC) decline of ≥ 10% from baseline * Acute exacerbation of pulmonary fibrosis * Respiratory-related hospitalization * All-cause mortality

Time frame: Up to approximately 3 years

Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score

Cohort 2

Time frame: Up to Week 52

Change from baseline in L-PF dyspnea domain score

Cohort 2

Time frame: Up to Week 52

Change from baseline in walking distance measured in 6-minute walk test (6MWT)

Cohort 2

Time frame: Up to Week 52

Time to the first occurrence of any of the components of the composite endpoint: time to first acute exacerbation of pulmonary fibrosis, first Respiratory-related hospitalization, or all-cause mortality

Data from ClinicalTrials.gov

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Local Institution - 0189

Birmingham, Alabama, United States

Local Institution - 0361

Phoenix, Arizona, United States

Local Institution - 0396

La Jolla, California, United States

Local Institution - 0193

Los Angeles, California, United States

Local Institution - 0398

Los Angeles, California, United States

Local Institution - 0389

Orange, California, United States

Local Institution - 0405

Sacramento, California, United States

Local Institution - 0185

San Francisco, California, United States

Local Institution - 0186

Stanford, California, United States

Local Institution - 0363

Aurora, Colorado, United States

...and 380 more locations

Time frame: Up to approximately 3 years

Time to absolute percent ppFVC decline of ≥ 10% from baseline

Cohort 2

Time frame: Up to approximately 3 years

Time to first acute exacerbation of pulmonary fibrosis

Cohort 2

Time frame: Up to approximately 3 years

Time to first Respiratory-related hospitalization

Cohort 2

Time frame: Up to approximately 3 years

Time to first pulmonary fibrosis-related hospitalization

Cohort 2

Time frame: Up to approximately 3 years

Time to death

Cohort 2

Time frame: Up to approximately 3 years

Change from baseline in L-PF fatigue domain score

Cohort 2

Time frame: Up to Week 52

Change from baseline in L-PF impacts module score

Cohort 2

Time frame: Up to Week 52

Change from baseline in cough numeric rating scale (NRS)

Cohort 2

Time frame: Up to Week 52

Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score

Cohort 2

Time frame: Up to Week 52

Change from baseline in EQ-5D-5L visual analog scale score

Cohort 2

Time frame: Up to Week 52

Rate of decline from baseline in FVC (mL)

Cohort 2

Time frame: Up to Week 52

Rate of decline in ppFVC from baseline

Cohort 2

Time frame: Up to Week 52

Change in ppFVC from baseline

Cohort 2

Time frame: Up to Week 52

Proportion of participants with absolute decline in ppFVC ≥10%

Cohort 2

Time frame: Up to Week 52

Proportion of participants with relative decline in ppFVC ≥10%

Cohort 2

Time frame: Up to Week 52

Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg)

Cohort 2

Time frame: Up to Week 52

Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline

Cohort 2

Time frame: Up to Week 52

Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT)

Cohort 2

Time frame: Up to Week 52

Number of participants with Adverse Events (AEs)

Cohorts 1 and 2

Time frame: Up to 28 days after last dose

Number of participants with Serious AEs (SAEs)

Cohorts 1 and 2

Time frame: Up to 28 days after last dose

Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP)

Cohorts 1 and 2

Time frame: Up to 28 days after last dose

Number of participants with AEs related to IMP

Cohorts 1 and 2

Time frame: Up to 28 days after last dose

Number of treatment-emergent deaths

Cohorts 1 and 2

Time frame: Up to 28 days after last dose

Number of participants with clinical laboratory abnormalities

Cohorts 1 and 2

Time frame: Up to 28 days after last dose

Number of participants with electrocardiogram (ECG) abnormalities

Cohorts 1 and 2

Time frame: Up to 28 days after last dose

Number of participants with vital sign abnormalities

Cohorts 1 and 2

Time frame: Up to 28 days after last dose