A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis
Led by Bristol-Myers Squibb
Updated on 2026-06-08
46
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9
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8 weeks
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What This Trial Is About
Researchers are evaluating the safety, tolerability, and drug levels of the investigational drug BMS-986454 in adults with Rheumatoid Arthritis who have not fully responded to methotrexate treatment. This Phase 1b study includes participants aged 18 to 65 who meet specific clinical criteria for Rheumatoid Arthritis and have swelling in at least one joint of the hand or wrist. The goal is to better understand how the drug behaves in the body and its safety profile.
The study is divided into two parts, each with groups receiving either BMS-986454 or a placebo. Participants will receive specified doses of the drug or placebo on scheduled days. The randomized, double-blind design means neither participants nor researchers know who receives the drug or placebo during the study. This approach helps compare the effects and safety of BMS-986454 to placebo. Participants will be followed for up to six months, during which safety will be closely monitored through physical exams, vital signs, ECGs, and lab tests. Researchers will also measure drug concentrations and immune responses in the blood. The main outcomes include tracking adverse events and drug levels over time. This comprehensive monitoring ensures detailed information about the drugs effects and participant well-being throughout the study period.
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A Study to Evaluate the Safety, Tolerability, and Drug L
📌 A 2-Part, Phase 1b Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of4 In Participants With Rheumatoid Arthritis (Vijayawada)
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📍 Vijayawada
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