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

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 4 months; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: BMS-986454; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07171983

IM055-1014

Details and patient eligibility

About

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

Enrollment: 46 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 4 patient groups, including a placebo group

Part A: Administration of BMS-986454

Experimental group

Treatment:

Drug: BMS-986454

Part A: Placebo

Placebo Comparator group

Treatment:

Other: Placebo

Part B: Administration of BMS-986454

Experimental group

Treatment:

Drug: BMS-986454

Part B: Placebo

Placebo Comparator group

Treatment:

Other: Placebo