RecruitingPhase 1NCT07171983
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis
Sponsor
Bristol-Myers Squibb
Enrollment
46 participants
Start Date
Feb 27, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria4
- 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 Criteria3
- 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.
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Interventions
DRUGBMS-986454
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Locations(9)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07171983
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