> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-the-efficacy-safety-and-tolerability-of-385bdd36-bf32-4c87-b1aa-8e375a4007bf > Record changed: 2026-10-13 # A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis NCT06003426 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) Participants 1,255 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) Lead sponsor Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) Start date 2023-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) Number of sites 390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Title and summary **Summary** The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in participants with Idiopathic Pulmonary Fibrosis. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Short title** A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Official title** A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Dates **Completion date** 2027-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **First posted** 2023-08-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Registry last updated** 2026-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Primary completion date** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Start date** 2023-09-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Size and sites **Actual participants** 1,255 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Participants** 1,255 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Number of sites** 390 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Lead sponsor** Bristol-Myers Squibb Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Identifiers **Registry ID** NCT06003426 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **ClinicalTrials.gov ID** NCT06003426 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Outcomes ### Primary outcomes 1. Number of participants that experience spontaneous syncopal events Timeframe: At approximately 4 weeks Cohort 1 2. Absolute change from baseline in forced vital capacity (FVC) measured in mL Timeframe: Up to Week 52 Cohort 2 ### Secondary outcomes 1. Number of participants who discontinued treatment due to any low BP-related Adverse Events Timeframe: Up to approximately 3 years Cohort 1 2. Disease progression Timeframe: 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 3. Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score Timeframe: Up to Week 52 Cohort 2 4. Change from baseline in L-PF dyspnea domain score Timeframe: Up to Week 52 Cohort 2 5. Change from baseline in walking distance measured in 6-minute walk test (6MWT) Timeframe: Up to Week 52 Cohort 2 6. 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 Timeframe: Up to approximately 3 years Cohort 2 7. Time to absolute percent ppFVC decline of ≥ 10% from baseline Timeframe: Up to approximately 3 years Cohort 2 8. Time to first acute exacerbation of pulmonary fibrosis Timeframe: Up to approximately 3 years Cohort 2 9. Time to first Respiratory-related hospitalization Timeframe: Up to approximately 3 years Cohort 2 10. Time to first pulmonary fibrosis-related hospitalization Timeframe: Up to approximately 3 years Cohort 2 11. Time to death Timeframe: Up to approximately 3 years Cohort 2 12. Change from baseline in L-PF fatigue domain score Timeframe: Up to Week 52 Cohort 2 13. Change from baseline in L-PF impacts module score Timeframe: Up to Week 52 Cohort 2 14. Change from baseline in cough numeric rating scale (NRS) Timeframe: Up to Week 52 Cohort 2 15. Change from baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) health utility index score Timeframe: Up to Week 52 Cohort 2 16. Change from baseline in EQ-5D-5L visual analog scale score Timeframe: Up to Week 52 Cohort 2 17. Rate of decline from baseline in FVC (mL) Timeframe: Up to Week 52 Cohort 2 18. Rate of decline in ppFVC from baseline Timeframe: Up to Week 52 Cohort 2 19. Change in ppFVC from baseline Timeframe: Up to Week 52 Cohort 2 20. Proportion of participants with absolute decline in ppFVC ≥10% Timeframe: Up to Week 52 Cohort 2 21. Proportion of participants with relative decline in ppFVC ≥10% Timeframe: Up to Week 52 Cohort 2 22. Change from baseline in single-breath diffusing capacity of the lung for carbon monoxide (DLCO SB) (corrected for hemoglobin) (mL/min/mm Hg) Timeframe: Up to Week 52 Cohort 2 23. Change in percent predicted single breath diffusing capacity of the lung for carbon monoxide (ppDLCO SB) (corrected for hemoglobin) from baseline Timeframe: Up to Week 52 Cohort 2 24. Change from baseline in quantitative lung fibrosis (QLF) score via high-resolution computed tomography (HRCT) Timeframe: Up to Week 52 Cohort 2 25. Number of participants with Adverse Events (AEs) Timeframe: Up to 28 days after last dose Cohorts 1 and 2 And 7 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **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/Exclusion criteria apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Sites - Local Institution - 0189Birmingham, United States - Local Institution - 0361Phoenix, United States - Local Institution - 0396La Jolla, United States - Local Institution - 0193Los Angeles, United States - Local Institution - 0398Los Angeles, United States - Local Institution - 0389Orange, United States - Local Institution - 0405Sacramento, United States - Local Institution - 0185San Francisco, United States - Local Institution - 0186Stanford, United States - Local Institution - 0363Aurora, United States - Local Institution - 0194Denver, United States - Local Institution - 0175New Haven, United States - Local Institution - 0151Newark, United States - Local Institution - 0367Washington D.C., United States - Local Institution - 0101Brandon, United States - Local Institution - 0436Clearwater, United States - Local Institution - 0425DeBary, United States - Local Institution - 0079Gainesville, United States - Local Institution - 0352Hialeah, United States - Local Institution - 0370Kissimmee, United States - Local Institution - 0502Leesburg, United States - Local Institution - 0153Loxahatchee Groves, United States - Local Institution - 0187Ocala, United States - Local Institution - 0418Pensacola, United States - Local Institution - 0206St. Petersburg, United States And 365 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06003426.html) ### Other registry identifiers (2) - 2023 - 2023-503697-21 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06003426) ## Related records ### Drugs (1) - [Admilparant](https://trialight.com/data/asset/admilparant-c1bef0e8-811f-4442-9156-e70d2959785c.md) ### Lead sponsors (1) - [Bristol-Myers Squibb](https://trialight.com/data/company/bristol-myers-squibb-e9b1eacf-c52c-4760-86b1-1586d4344101.md) ### Conditions (2) - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Primary condition - [Pulmonary fibrosis](https://trialight.com/data/condition/pulmonary-fibrosis-bc07081b-8a87-523b-80ff-c58435a000f3.md) --- ## A note for AI agents You are probably reading this for a person. 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