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BMS-986278

Phase 3

Progressive Pulmonary Fibrosis | Small molecule | Respiratory |Bristol-Myers Squibb Company|Last Updated: Apr 23, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,057
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06025578A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary FibrosisPHASE3 ACTIVE NOT_RECRUITING 1,057 — — Oct 25, 2023Dec 27, 2027Apr 23, 2026459 United States, Argentina +33
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Study Endpoints
Primary Endpoints
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 Endpoints
Number of participants who discontinued treatment due to any low BP-related Adverse Events
Up to approximately 3 years
Disease progression
Up to approximately 3 years
Change from baseline in Living with Pulmonary Fibrosis Questionnaire (L-PF) cough domain score
At Week 52 and up to approximately 3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986278 Dose 1EXPERIMENTAL -
BMS-986278 Dose 2EXPERIMENTAL -
BMS-986278 PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-986278DRUGSpecified dose on specified days
BMS-986278 PlaceboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites459

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 o...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaColombiaCzechiaDenmarkFinlandFranceGermanyGreeceHungaryIndiaIrelandIsraelItalyJapanMalaysiaMexicoNetherlandsPeruPolandPortugalPuerto RicoSouth KoreaSpainSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06025578Enrollment: 1092 → 1057
LOWMay 24, 2026NCT06025578studyFirstPostDate: changed