A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
- Conditions
- Progressive Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT06025578
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1092
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986278 Dose 2 BMS-986278 - BMS-986278 Dose 1 BMS-986278 - BMS-986278 Placebo BMS-986278 Placebo -
- Primary Outcome Measures
Name Time Method 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 At Week 52 Cohort 2
- Secondary Outcome Measures
Name Time Method Rate of decline in ppFVC from baseline At Week 52 Cohort 2
Time to first pulmonary fibrosis-related hospitalization. Up to approximately 3 years Cohort 2
Change from baseline in L-PF impacts module score At Week 52 and up to approximately 3 years Cohort 2
Time to all-cause mortality Up to approximately 3 years Cohort 2
Number of participants who discontinued treatment due to any low BP-related Adverse Events Up to approximately 3 years Cohort 1
Change from baseline in L-PF fatigue domain score At Week 52 and up to approximately 3 years Cohort 2
Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score At Week 52 Cohort 2
Proportion of participants with relative decline in ppFVC ≥10% At Week 52 Cohort 2
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 mortalityChange from baseline in L-PF dyspnea domain score At Week 52 and up to approximately 3 years Cohort 2
Change from baseline in walking distance measured in 6-minute walk test (6MWT) At 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
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score At Week 52 and 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
Rate of decline from baseline in FVC (mL) At Week 52 Cohort 2
Change from baseline in EQ-5D-5L visual analog scale score At 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 At Week 52 Cohort 2
Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT) At Week 52 Cohort 2
Number of participants with AEs leading to early discontinuation of investigational medicinal product (IMP) Up to 28 days after last dose Cohort 2
Number of participants with electrocardiogram (ECG) abnormalities Up to 28 days after last dose Cohort 2
Change from baseline in cough numeric rating scale (NRS) At Week 52 and up to approximately 3 years Cohort 2
Change in ppFVC from baseline At Week 52 Cohort 2
Proportion of participants with absolute decline in ppFVC ≥10% At 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) At Week 52 Cohort 2
Number of participants with Adverse Events (AEs) Up to 28 days after last dose Cohort 2
Number of participants with AEs related to IMP Up to 28 days after last dose Cohort 2
Number of participants with Serious AEs (SAEs) Up to 28 days after last dose Cohort 2
Number of treatment-emergent deaths Up to 28 days after last dose Cohort 2
Number of participants with clinical laboratory abnormalities Up to 28 days after last dose Cohort 2
Number of participants with vital sign abnormalities Up to 28 days after last dose Cohort 2
Trial Locations
- Locations (535)
Local Institution - 0535
🇺🇸Newport Beach, California, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
Vanderbilt Lung Institute - One Hundred Oaks
🇺🇸Nashville, Tennessee, United States
King George's Medical University
🇮🇳Lucknow, UP, India
Hospital Umum Sarawak
🇲🇾Kuching, Malaysia
Centro Respiratorio de México
🇲🇽México, DIF, Mexico
Investigacion Clinica por la Slaud de Cordoba - SALUDCOR
🇲🇽Córdoba, VER, Mexico
Clínica de día Jockey Salud
🇵🇪Lima, LIM, Peru
Clinica Providencia
🇵🇪San Miguel, LIM, Peru
Clínica Belén
🇵🇪Piura, PIU, Peru
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