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

Phase 3Active Not RecruitingNCT06025578

Bristol-Myers Squibb1,092 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,092

Conditions

Progressive Pulmonary Fibrosis

Interventions

BMS-986278DRUG

Specified dose on specified days

BMS-986278 PlaceboDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria * Diagnosis of interstitial lung disease (ILD) with features consistent with progressive ILD within 24 months prior to screening, and ≥ 10% extent of fibrosis on screening high-resolution computed tomography (HRCT). * 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. * Mycophenolate mofetil (MMF), mycophenolic acid (MA), azathioprine (AZA), and Tacrolimus are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on MMF, MA, AZA, or tacrolimus, participants must not have taken these medications within 28 days prior to screening. * Traditional disease-modifying antirheumatic drug (DMARDs) (eg. Methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on traditional DMARD, participants must not have taken these medications within 28 days prior to screening. * Biologic DMARDs (eg. TNF blockers and IL-1 inhibitors) and Janus kinase inhibitors (JAK inhibitors eg. tofacitinib, upadacitinib) are permitted provided that the participant is on a stable dose for at least 90 days prior to screening. If not currently on Biologic DMARD or JAK inhibitor, participants must not have taken 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 * Idiopathic pulmonary fibrosis with usual interstitial pneumonia (UIP) verification at screening. * 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; a previous malignancy with less than 2 years free of recurrence; and a biopsy that is suspicious for malignancy and the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations. * Use of systemic corticosteroids equivalent to prednisone \> 15 mg/day is not allowed within 4 weeks prior to screening and during the study. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (459)

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: At 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: At Week 52 and up to approximately 3 years

Change from baseline in L-PF dyspnea domain score

Cohort 2

Time frame: At Week 52 and up to approximately 3 years

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

Cohort 2

Time frame: At 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 - 0046

Birmingham, Alabama, United States

Local Institution - 0314

Phoenix, Arizona, United States

Local Institution - 0336

La Jolla, California, United States

Local Institution - 0212

Los Angeles, California, United States

Local Institution - 0019

Los Angeles, California, United States

Local Institution - 0535

Newport Beach, California, United States

Local Institution - 0366

Orange, California, United States

Local Institution - 0341

Sacramento, California, United States

Local Institution - 0015

San Francisco, California, United States

Local Institution - 0352

Stanford, California, United States

...and 449 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 all-cause mortality

Cohort 2

Time frame: Up to approximately 3 years

Change from baseline in L-PF fatigue domain score

Cohort 2

Time frame: At Week 52 and up to approximately 3 years

Change from baseline in L-PF impacts module score

Cohort 2

Time frame: At Week 52 and up to approximately 3 years

Change from baseline in cough numeric rating scale (NRS)

Cohort 2

Time frame: At Week 52 and up to approximately 3 years

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

Cohort 2

Time frame: At Week 52

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

Cohort 2

Time frame: At Week 52

Rate of decline from baseline in FVC (mL)

Cohort 2

Time frame: At Week 52

Rate of decline in ppFVC from baseline

Cohort 2

Time frame: At Week 52

Change in ppFVC from baseline

Cohort 2

Time frame: At Week 52

Proportion of participants with absolute decline in ppFVC ≥10%

Cohort 2

Time frame: At Week 52

Proportion of participants with relative decline in ppFVC ≥10%

Cohort 2

Time frame: At 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: At 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: At Week 52

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

Cohort 2

Time frame: At Week 52

Number of participants with Adverse Events (AEs)

Cohort 2

Time frame: Up to 28 days after last dose

Number of participants with Serious AEs (SAEs)

Cohort 2

Time frame: Up to 28 days after last dose

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

Cohort 2

Time frame: Up to 28 days after last dose

Number of participants with AEs related to IMP

Cohort 2

Time frame: Up to 28 days after last dose

Number of treatment-emergent deaths

Cohort 2

Time frame: Up to 28 days after last dose

Number of participants with clinical laboratory abnormalities

Cohort 2

Time frame: Up to 28 days after last dose

Number of participants with electrocardiogram (ECG) abnormalities

Cohort 2

Time frame: Up to 28 days after last dose

Number of participants with vital sign abnormalities

Cohort 2

Time frame: Up to 28 days after last dose