NCT07412704招募中1 期
A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 82
- 主要终点
- Number of participants with treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.
排除标准
- •Juvenile arthritis or onset of inflammatory arthritis before age
- •Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.
- •Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Cohort A1
Experimental
干预措施: BMS-986528 (Drug)
Cohort A2
Experimental
干预措施: BMS-986528 (Drug)
Cohort A3
Experimental
干预措施: BMS-986528 (Drug)
Cohort B2
Experimental
干预措施: BMS-986528 (Drug)
Cohort A5
Experimental
干预措施: BMS-986528 (Drug)
Cohort A6
Experimental
干预措施: BMS-986528 (Drug)
Cohort A7
Experimental
干预措施: BMS-986528 (Drug)
Cohort A8
Experimental
干预措施: BMS-986528 (Drug)
Cohort A4
Experimental
干预措施: BMS-986528 (Drug)
Cohort B1
Experimental
干预措施: BMS-986528 (Drug)
结局指标
主要结局
Number of participants with treatment-emergent adverse events (TEAEs)
时间窗: Up to Week 54
Number of participants with Serious Adverse Events (SAEs)
时间窗: Up to Week 54
次要结局
- Apparent volume of distribution of terminal phase (Vz/F)(Up to Week 54)
- Change from baseline in numbers and fractions of B cells(Up to Week 54)
- Change from baseline in immunoglobulin G (igG) levels(Up to Week 54)
- Change from baseline in igM levels(Up to Week 54)
- Change from baseline in igE levels(Up to Week 54)
- Change from baseline in igD levels(Up to Week 54)
- Change from baseline in igA levels(Up to Week 54)
- Number of participants with anti-drug antibody (ADA)(Up to Week 54)
- Change from baseline in disease activity score 28-C-reactive protein (DAS28-CRP)(At Week 12)
- area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))(Up to Week 54)
- Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF))(Up to Week 54)
- Apparent terminal serum half-life (T-HALF)(Up to Week 54)
- Apparent total body clearance (CLT/F)(Up to Week 54)
- Maximum observed concentration (Cmax)(Up to Week 54)
- Time of maximum observed concentration (Tmax)(Up to Week 54)
研究者
研究点 (82)
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