NCT07171983招募中1 期
A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 9
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with Rheumatoid Arthritis must have onset after age
- •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 -
- •Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.
排除标准
- •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 -
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part B: Administration of BMS-986454
Experimental
干预措施: BMS-986454 (Drug)
Part A: Placebo
Placebo Comparator
干预措施: Placebo (Other)
Part B: Placebo
Placebo Comparator
干预措施: Placebo (Other)
Part A: Administration of BMS-986454
Experimental
干预措施: BMS-986454 (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 6 months
Number of participants with serious adverse events (SAEs)
时间窗: Up to 6 months
Number of participants with physical examination findings
时间窗: Up to 6 months
Number of participants with vital sign measurement findings
时间窗: Up to 6 months
Number of participants with 12-lead electrocardiogram (ECG) findings
时间窗: Up to 6 months
Number of participants with clinical laboratory test findings
时间窗: Up to 6 months
次要结局
- Maximum observed concentration (Cmax)(Up to 6 months)
- Concentration at the end of a dosing interval (Ctau)(Up to 6 months)
- Trough observed plasma concentration (Ctrough)(Up to 6 months)
- Time of maximum observed concentration (Tmax)(Up to 6 months)
- Area under the curve over the dosing interval (AUC(TAU))(Up to 6 months)
- Area under the serum concentration time curve extrapolated to infinite time (AUC(INF))(Up to 6 months)
- Area under the serum concentration time curve from time zero to the last quantifiable concentration (AUC(0-T))(Up to 6 months)
- Terminal-phase half-life (T-HALF)(Up to 6 months)
- Accumulation index of the area under the curve over the dosing interval (AI_AUC(TAU))(Up to 6 months)
- Accumulation index of the maximum observed concentration (AI_Cmax)(Up to 6 months)
- Apparent total body clearance (CLT/F)(Up to 6 months)
- Apparent volume of distribution of terminal phase (Vz/F)(Up to 6 months)
- Number of participants with anti-drug antibody (ADA) formation(Up to 6 months)
研究者
研究点 (9)
Loading locations...
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