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BMS-986278

Phase 3

Idiopathic Pulmonary Fibrosis | Small molecule | Respiratory |Bristol-Myers Squibb Company|Last Updated: Aug 14, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment1,255

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986278 · 17 trials · 9 indications

Phase 3 3Phase 2 1Phase 1 13
NCT07441408Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary FibrosisPulmonary Fibrosis
NOT YET_RECRUITING2,380 Analytics
NCT06025578A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary FibrosisProgressive Pulmonary Fibrosis
ACTIVE NOT_RECRUITING1,057 Analytics
NCT06003426A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis
ACTIVE NOT_RECRUITING1,255 Analytics
PHASE3NOT YET_RECRUITING
Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis
Pulmonary Fibrosis
NCT074414082,380
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PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
NCT060255781,057
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PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
NCT060034261,255
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Study Endpoints

Primary Endpoints

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to Week 100
Number of Participants With Serious Adverse Events (SAEs)
Up to Week 100
Number of Participants With AEs leading to Discontinuation
Up to Week 100
Number of Participants With AEs leading to Deaths
Up to Week 100
Number of Participants With Clinically Significant Laboraty Abnormalities
Up to Week 100
Number of Participants With Clinically Significant Electocardiogram (ECG) Abnormalities
Up to Week 100
Number of Participants With Clinically Significant Vital Sign Abnormalities
Up to Week 100
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

Change From Baseline in Percent Predicted Forced Vital Capacity (ppFVC) in IPF Participants
From baseline (first dose) up to week 26

Percent predicted forced vital capacity (ppFVC) is the percentage of predicted value per participant of forced vital capacity (FVC). FVC is defined as the maximum capacity of air that a participant can exhale after a maximum inspiration as measured by the volume of air exhaled in a spirometer. The data is reported as percent change from baseline in ppFVC. Percent change from baseline is a calculation that expresses the change in a value compared to its initial starting point (baseline) as a percentage, showing how much a value has increased or decreased relative to its original level; it's calculated by subtracting the baseline value from the new value, dividing by the baseline value, and then multiplying by 100%. The percent change in this endpoint was calculated from ppFVC values taken at baseline, which is defined as the measurement of ppFVC taken at first dose, and ppFVC values taken at Week 26. This endpoint reports data for the IPF cohort only as pre-specified in the protocol.

Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Up to Day 13
Number of participants with non-serious Adverse Events (AEs)
Until 28 days post last treatment dose

Part A

Number of participants with Serious AEs (SAEs)
Until 28 days post last treatment dose

Part A

Number of participants with AEs leading to study intervention discontinuation
Until 28 days post last treatment dose

Part A

Number of participants with vital sign abnormalities
Up to Day 18

Part A

Number of participants with clinical laboratory assessment abnormalities
Up to Day 18

Part A

Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Up to Day 18

Part A

Number of participants with physical examination abnormalities
Up to Day 18

Part A

Maximum observed concentration (Cmax)
Up to Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Up to Day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Up to Day 8
Maximum observed plasma concentration (Cmax)
Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
Predose and post-dose up to Day 28
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Up to 33 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 33 days
Time of maximum observed concentration (Tmax)
Up to Day 19
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to Day 19
Mean placebo-corrected change from baseline in systolic blood pressure (SBP) (Part 1)
Up to 16 days
Maximum observed plasma concentration (Cmax) (Part 2)
Up to 14 days
Time of maximum observed plasma concentration (Tmax) (Part 2)
Up to 14 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) (Part 2)
Up to 14 days
Maximum observed plasma concentration (Cmax) of BMS-986278
Up to 15 days
Maximum observed plasma concentration (Cmax) of total radioactivity (TRA)
Up to 15 days
Time of maximum observed plasma concentration (Tmax) of BMS-986278
Up to 15 days
Time of maximum observed plasma concentration (Tmax) of TRA
Up to 15 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278
Up to 15 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA
Up to 15 days
Maximum plasma concentration (Cmax) of BMS-986278
Up to 5 days
Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278
Up to 5 days
Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments
Up to 5 days
Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton
Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton
Up to day 5 of each period (Each period is 7 days; 3 periods total)
Maximum observed plasma concentration (Cmax) for BMS-986278
Day 1 and 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for BMS-986278
Up to 24 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] for BMS-986278
Day 1 and 8
Terminal phase half-life (T-HALF) for BMS-986278
Day 1 and 8
Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation
Up to 30 days
Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations
Up to 30 days

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

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986278 ArmEXPERIMENTAL -
BMS-986278 Dose 1EXPERIMENTAL -
BMS-986278 Dose 2EXPERIMENTAL -
BMS-986278 PlaceboPLACEBO_COMPARATOR -
IPF Dose 1 + Post Treatment Follow-up or OTEEXPERIMENTALIPF (Idiopathic Pulmonary Fibrosis) OTE (Optional Treatment Extension)
IPF Dose 2 + Post Treatment Follow-up or OTEEXPERIMENTAL -
IPF Placebo + Post Treatment Follow-up or OTEPLACEBO_COMPARATOR -
PF-ILD Dose 1 + Post Treatment Follow-up or OTEEXPERIMENTALPF-ILD (Progressive Fibrotic Interstitial Lung Disease)
PF-ILD Dose 2 + Post Treatment Follow-up or OTEEXPERIMENTAL -
PF-ILD Placebo + Post Treatment Follow-up or OTEPLACEBO_COMPARATOR -
Treatment AEXPERIMENTAL -
Treatment BEXPERIMENTAL -
Treatment CPLACEBO_COMPARATOR -
Treatment DEXPERIMENTAL -
Part AEXPERIMENTAL -
Part B1/B2 Treatment AEXPERIMENTAL -
Part B1/B2 Treatment BEXPERIMENTAL -
Part B1/B2 Treatment CEXPERIMENTAL -
Part B1/B2 Treatment DEXPERIMENTAL -
Part B3 Treatment AEXPERIMENTAL -
Part B3 Treatment BEXPERIMENTAL -
Part B3 Treatment CEXPERIMENTAL -
Part B3 Treatment DEXPERIMENTAL -
Group A and CEXPERIMENTAL -
Group B: Period 1EXPERIMENTAL -
Group B: Period 2EXPERIMENTAL -
Group A: Mild Hepatic Impairment BMS-986278EXPERIMENTAL -
Group B: Moderate Hepatic Impairment BMS-986278EXPERIMENTAL -
Group C: Severe Hepatic Impairment BMS-986278EXPERIMENTAL -
Group D: Normal Hepatic Function BMS-986278EXPERIMENTAL -
Treatment A: DRSP/EEEXPERIMENTAL -
Treatment B: BMS-986278/DRSP/EEEXPERIMENTAL -
BMS-986278, followed by itraconazoleEXPERIMENTAL -
BMS-986278, followed by gemfibrozilEXPERIMENTAL -
BMS-986278, followed by carbamazepineEXPERIMENTAL -
Group 1EXPERIMENTAL -
Group 2EXPERIMENTAL -
Part 1: BMS-986278 + SildenafilEXPERIMENTAL -
Part 1: Placebo + SildenafilPLACEBO_COMPARATOR -
Part 2: BMS-986278EXPERIMENTAL -
Part 2: PlaceboPLACEBO_COMPARATOR -
Treatment A: BMS-986278 suspension, fastedEXPERIMENTAL -
Treatment B: BMS-986278 tablet, fastedEXPERIMENTAL -
Treatment C: BMS-986278 tablet, fedEXPERIMENTAL -
Treatment D: BMS-986278 tablet + esomeprazole capsule, fastedEXPERIMENTAL -
BMS-986278EXPERIMENTAL -
PirfenidoneEXPERIMENTAL -
BMS-986278 + PirfenidoneEXPERIMENTAL -
BMS-986278 + RifampinEXPERIMENTALTreatment period A: BMS-986278 alone Treatment period B: Rifampin followed by BMS-986278
Single Ascending DoseEXPERIMENTALBMS-986278 or placebo
Multiple Ascending DoseEXPERIMENTALBMS-986278 or placebo

Interventions

NameTypeDescription
BMS-986278DRUGSpecified dose on specified days
BMS-986278 PlaceboDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
MoxifloxacinDRUGSpecified dose on specified days
Drospirenone/Ethinyl EstradiolDRUGSpecified dose on specified days
ItraconazoleDRUGSpecified dose on specified days
GemfibrozilDRUGSpecified dose on specified days
CarbamazepineDRUGSpecified dose on specified days
SildenafilDRUGSpecified dose on specified days
[14C] BMS-986278DRUGSpecified dose on specified days
Kinevac®DRUGSpecified dose on specified days
BMS-986278 TabletDRUGSpecified dose on specified days
EsomeprazoleDRUGSpecified dose on specified days
BMS-986278 suspensionDRUGSpecified dose on specified days
PirfenidoneDRUGcapsule
RifampinDRUGOral administration 600 mg
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Eligibility Criteria

Age Range21 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites275

Inclusion Criteria: \- Participants must have participated in either IM027068 or IM0271015 without discontinuing treatment permanently due to withdrawal of informed consent in either IM027068 or IM0271015. Exclusion Criteria: * Any disease/condition that, in the investigator's judgment, may pose ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChileChinaColombiaDenmarkFinlandFranceGermanyGreeceIndiaIrelandIsraelItalyJapanMexicoNetherlandsPeruPortugalSouth KoreaSpainTaiwanUnited KingdomAustriaCzechiaHungaryMalaysiaPolandPuerto RicoSwitzerlandTurkey (Türkiye)
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Competitive Landscape -Idiopathic Pulmonary Fibrosis 19 trials

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986278
United Therapeutics CorporationUTHR2PHASE3Treprostinil
AbbVie, Inc.ABBV2PHASE2ABBV-142
PureTech Health PLC Sponsored ADRPRTC2PHASE3Deupirfenidone, Pirfenidone
Syndax Pharmaceuticals IncSNDX1PHASE2Axatilimab
Contineum Therapeutics, Inc. Class ACTNM1PHASE2PIPE-791 Dose A, PIPE-791 Dose B
Rein Therapeutics, IncRNTX1PHASE2LTI-03
Sunshine Biopharma IncorporatedSBFM2PHASE3HEC585, Pirfenidone
Cumberland Pharmaceuticals Inc.CPIX1PHASE2Ifetroban
Avalyn Pharma IncAVLN3PHASE2AP01
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Recent Changes (Last 90 Days)

MEDIUMSep 3, 2026NCT07422298TRIAL_REMOVED: changed
MEDIUMSep 3, 2026NCT07422298TRIAL_REMOVED: changed
MEDIUMSep 3, 2026NCT07422298TRIAL_REMOVED: changed
LOWAug 14, 2026NCT07441408Enrollment: 2277 → 2380
LOWAug 14, 2026NCT07441408Enrollment: 2277 → 2380
HIGHAug 3, 2026NCT07422298Status: RECRUITING → COMPLETED
HIGHAug 3, 2026NCT07422298Status: RECRUITING → COMPLETED
LOWJul 28, 2026NCT07441408lastUpdatePostDate: changed
LOWJul 28, 2026NCT07441408lastUpdatePostDate: changed
LOWJul 2, 2026NCT07441408lastUpdatePostDate: changed
LOWJul 2, 2026NCT07441408lastUpdatePostDate: changed
LOWJun 16, 2026NCT07441408lastUpdatePostDate: changed
LOWJun 16, 2026NCT07441408lastUpdatePostDate: changed
LOWJun 16, 2026NCT07441408lastUpdatePostDate: changed

Frequently asked questions about BMS-986278

What is BMS-986278 used for?

BMS-986278 is an investigational small molecule being developed for pulmonary fibrosis, progressive pulmonary fibrosis, and idiopathic pulmonary fibrosis. It is also studied in healthy volunteers and in participants with hepatic impairment. The drug is currently in Phase 1 clinical development and is not yet approved.

Who makes BMS-986278?

BMS-986278 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics.

What phase is BMS-986278 in?

BMS-986278 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing and completed trials are early-stage studies focused on safety, tolerability, and drug levels in healthy participants and specific patient populations.

What clinical trials is BMS-986278 in?

BMS-986278 has been studied in several Phase 1 trials, including NCT05805904 in healthy Chinese participants, NCT05985590 in healthy female participants, NCT06746402 in healthy participants, and NCT07422298 in healthy participants. These trials evaluate drug levels, safety, tolerability, and cardiac effects.

Is BMS-986278 being studied in healthy volunteers?

Yes, BMS-986278 is being studied in healthy volunteers. Multiple Phase 1 trials, such as NCT05805904, NCT05985590, NCT06746402, and NCT07422298, enroll healthy participants to assess the drug's safety, tolerability, pharmacokinetics, and effects on cardiac repolarization.