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A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis

RECRUITINGPhase 1Sponsored by Bristol-Myers Squibb
Actively Recruiting
PhasePhase 1
SponsorBristol-Myers Squibb
Started2026-02-27
Est. completion2027-06-28
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis

Eligibility

Age: 18 Years – 65 YearsHealthy volunteers accepted
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 of the hand or wrist by clinical examination at screening and Day -1.
* Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.

Exclusion Criteria:

* Participants must not have any significant medical condition, with the exception of Rheumatoid Arthritis (including but not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders) that, in the Investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
* Participants must not have any condition aside from RA that confounds the ability to interpret data from the study.
* Participants must not have severe Rheumatoid Arthritis as assessed by Disease Activity Score 28 c-reactive protein (DAS28-CRP) at screening or Day -1.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Conditions2

ArthritisRheumatoid Arthritis

Interventions1

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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