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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT07171983

Run by

Bristol-Myers Squibb

People needed

46

Starts

2026-02-27

Expected to finish

2027-08-25

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Krishna Institute of Medical Sciences Limited — Secunderabad, Telangana, India (enrolling)
• Apollo Hospitals Ahmedabad — Ahmedabad, Gujarat, India (enrolling)
• Life Point Mutispecialty Hospital Pvt. Ltd. — Pune, Maharashtra, India (enrolling)
• Kalinga Institute of Medical Sciences- Bhubaneswar — Bhubaneswar, Odisha, India (enrolling)
• Nizams Institute Of Medical Sciences — Hyderabad, Andhra Pradesh, India (enrolling)
• All India Institute of Medical Sciences (AIIMS) - Nagpur — Nagpur, Maharashtra, India (enrolling)
• Local Institution - 0003 — Bangalore, Karnataka, India
• Local Institution - 0009 — Mysuru, Karnataka, India
• Local Institution - 0002 — Hyderabad, Telangana, India

Full record on ClinicalTrials.gov

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