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BMS-986454

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Jul 20, 2026

Target and mechanism

Molecular targetCD19
ModalitySmall molecule

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

Clinical trial landscape

BMS-986454 · 2 trials · 2 indications

Phase 1 2
NCT07171983A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid ArthritisRheumatoid Arthritis
RECRUITING46 Analytics
NCT06086886A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy ParticipantsHealthy Participants
COMPLETED63 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants
Healthy ParticipantsUnlock 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
Number of participants with severe adverse events (SAEs)
Up to approximately 4 months
Number of participants with physical examination abnormalities
Up to approximately 4 months
Number of participants with vital sign abnormalities
Up to approximately 4 months
Number of participants with electrocardiogram (ECG) abnormalities
Up to approximately 4 months
Number of participants with clinical laboratory abnormalities
Up to approximately 4 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 -
BMS-986454EXPERIMENTAL -
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:IndiaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 20, 2026NCT07171983lastUpdatePostDate: changed
LOWJul 20, 2026NCT07171983lastUpdatePostDate: changed
LOWJun 8, 2026NCT07171983lastUpdatePostDate: changed
LOWJun 8, 2026NCT07171983lastUpdatePostDate: changed
LOWJun 8, 2026NCT07171983lastUpdatePostDate: changed
LOWMay 26, 2026NCT07171983Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07171983studyFirstPostDate: changed

Frequently asked questions about BMS-986454

What is BMS-986454 used for?

BMS-986454 is an investigational small molecule being developed by Bristol-Myers Squibb for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, with studies evaluating its safety, tolerability, and drug levels in healthy participants and in patients with rheumatoid arthritis.

What does BMS-986454 target?

BMS-986454 targets CD19, a protein found on the surface of B cells. By targeting CD19, the drug may modulate B-cell activity, which is relevant to autoimmune conditions like rheumatoid arthritis. This mechanism is being investigated in early-stage clinical trials.

Who makes BMS-986454?

BMS-986454 is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and tolerability.

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 regulatory authorities. Two Phase 1 trials are listed: one completed study in healthy participants and one ongoing study in participants with rheumatoid arthritis.

What clinical trials is BMS-986454 in?

BMS-986454 has two Phase 1 clinical trials. NCT06086886, a completed study in healthy participants in the United Kingdom with 63 enrolled, and NCT07171983, a recruiting study in participants with rheumatoid arthritis in India with a target enrollment of 46. Both are randomized, double-blind, and placebo-controlled.

Is BMS-986454 the same as any other drug?

No alternative names for BMS-986454 have been disclosed. The drug is referred to solely by its development code, BMS-986454, in clinical trial registrations and company communications.