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BMS-986454

Phase 1

Rheumatoid Arthritis | Small Molecules | Immunology |Bristol-Myers Squibb Company|Trials Updated: Oct 1, 2026

BMS-986454 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2023

BMS-986454 target and mechanism

Molecular targetCD19
ModalitySmall Molecules

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

BMS-986454 clinical trials

BMS-986454 · 1 trial · 1 indication

Phase 1 1
NCT07171983A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid ArthritisRheumatoid Arthritis
RECRUITING46 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to 6 months
Number of participants with serious adverse events (SAEs)
Up to 6 months
Number of participants with physical examination findings
Up to 6 months
Number of participants with vital sign measurement findings
Up to 6 months
Number of participants with 12-lead electrocardiogram (ECG) findings
Up to 6 months
Number of participants with clinical laboratory test findings
Up to 6 months

Secondary Endpoints

Maximum observed concentration (Cmax)
Up to 6 months
Concentration at the end of a dosing interval (Ctau)
Up to 6 months
Trough observed plasma concentration (Ctrough)
Up to 6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Administration of BMS-986454EXPERIMENTAL -
Part A: PlaceboPLACEBO_COMPARATOR -
Part B: Administration of BMS-986454EXPERIMENTAL -
Part B: PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BMS-986454DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Participants with Rheumatoid Arthritis must have onset after age 18. * Participants who meet 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA. * Participants must have evidence of swelling in at least 1 joint o...

Countries:India
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Recent Changes (Last 90 Days)

LOWOct 1, 2026NCT07171983lastUpdatePostDate: changed
LOWOct 1, 2026NCT07171983lastUpdatePostDate: changed

Frequently asked questions about BMS-986454

What is BMS-986454?

BMS-986454 is an investigational small molecule drug being developed by Bristol-Myers Squibb Company (BMY) for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development and has not been approved by the FDA. It is designed to target CD19.

What is BMS-986454 used for?

BMS-986454 is being studied for use in rheumatoid arthritis, an autoimmune condition affecting the joints. The only clinical trial of BMS-986454 to date enrolls participants with rheumatoid arthritis. It remains investigational and is not approved for any indication.

What does BMS-986454 target?

BMS-986454 targets CD19. CD19 is a protein found on the surface of B cells, and targeting it is intended to modulate the B cell driven immune response implicated in rheumatoid arthritis. Bristol-Myers Squibb is evaluating this small molecule in a Phase 1 study.

Who makes BMS-986454?

Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of BMS-986454. The company is running the Phase 1 clinical program for the drug in rheumatoid arthritis.

What phase is BMS-986454 in?

BMS-986454 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 program is evaluating the drug in participants with rheumatoid arthritis.

What clinical trials is BMS-986454 in?

BMS-986454 is being studied in one clinical trial, NCT07171983, titled A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis. The trial is a recruiting, randomized, double-blind, placebo-controlled Phase 1 study with an planned enrollment of 46 participants in India.