Status:
NOT_YET_RECRUITING
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 25 2027
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT07171983
Start Date
January 22 2026
End Date
August 25 2027
Last Update
September 15 2025
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