Idiopathic Pulmonary Fibrosis
Conditions
Keywords
BMS-986278, LPA1 antagonist, IPF, Pulmonary fibrosis
Brief summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis.
Interventions
DRUGBMS-986278
Specified dose on specified days
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that experience spontaneous syncopal events | At approximately 4 weeks | Cohort 1 |
| Absolute change from baseline in forced vital capacity (FVC) measured in mL | Up to Week 52 | Cohort 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinued treatment due to any low BP-related Adverse Events | Up to approximately 3 years | Cohort 1 |
| Disease progression | Up to approximately 3 years | 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 |
| Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score | Up to Week 52 | Cohort 2 |
| Change from baseline in L-PF dyspnea domain score | Up to Week 52 | Cohort 2 |
| Change from baseline in walking distance measured in 6-minute walk test (6MWT) | Up to Week 52 | Cohort 2 |
| 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 | Up to approximately 3 years | Cohort 2 |
| Time to absolute percent ppFVC decline of ≥ 10% from baseline | Up to approximately 3 years | Cohort 2 |
| Time to first acute exacerbation of pulmonary fibrosis | Up to approximately 3 years | Cohort 2 |
| Time to first Respiratory-related hospitalization | Up to approximately 3 years | Cohort 2 |
| Time to first pulmonary fibrosis-related hospitalization | Up to approximately 3 years | Cohort 2 |
| Time to death | Up to approximately 3 years | Cohort 2 |
| Change from baseline in L-PF fatigue domain score | Up to Week 52 | Cohort 2 |
| Change from baseline in L-PF impacts module score | Up to Week 52 | Cohort 2 |
| Change from baseline in cough numeric rating scale (NRS) | Up to Week 52 | Cohort 2 |
| Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score | Up to Week 52 | Cohort 2 |
| Change from baseline in EQ-5D-5L visual analog scale score | Up to Week 52 | Cohort 2 |
| Rate of decline from baseline in FVC (mL) | Up to Week 52 | Cohort 2 |
| Rate of decline in ppFVC from baseline | Up to Week 52 | Cohort 2 |
| Change in ppFVC from baseline | Up to Week 52 | Cohort 2 |
| Proportion of participants with absolute decline in ppFVC ≥10% | Up to Week 52 | Cohort 2 |
| Proportion of participants with relative decline in ppFVC ≥10% | Up to Week 52 | Cohort 2 |
| Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg) | Up to Week 52 | Cohort 2 |
| Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline | Up to Week 52 | Cohort 2 |
| Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT) | Up to Week 52 | Cohort 2 |
| Number of participants with Adverse Events (AEs) | Up to 28 days after last dose | Cohorts 1 and 2 |
| Number of participants with Serious AEs (SAEs) | Up to 28 days after last dose | Cohorts 1 and 2 |
| Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP) | Up to 28 days after last dose | Cohorts 1 and 2 |
| Number of participants with AEs related to IMP | Up to 28 days after last dose | Cohorts 1 and 2 |
| Number of treatment-emergent deaths | Up to 28 days after last dose | Cohorts 1 and 2 |
| Number of participants with clinical laboratory abnormalities | Up to 28 days after last dose | Cohorts 1 and 2 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 28 days after last dose | Cohorts 1 and 2 |
| Number of participants with vital sign abnormalities | Up to 28 days after last dose | Cohorts 1 and 2 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Puerto Rico, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed