A Phase 1b Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Incidence of Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety and drug levels of BMS-986256 in participants with cutaneous lupus erythematosus.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •a) Must have one of following diagnoses: i) Meet European League Against Rheumatoid (EULAR)/American College of Rheumatology 2019 Classification Criteria for systemic lupus erythematosus (SLE) OR ii) Biopsy-proven acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), or discoid lupus erythematosus (DLE): Participants without a concurrent SLE diagnosis are eligible b) Active cutaneous lupus disease, defined as a modified Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (mCLASI-A) score ≥ 6 c) Active cutaneous lupus skin lesion(s) amenable to biopsy
- •Women of childbearing potential (WOCBP) and men must agree to follow instructions for method(s) of contraception, if applicable
排除标准
- •Active severe or unstable neuropsychiatric SLE
- •Active, severe Lupus Nephritis (LN)
- •Any British Isles Lupus Assessment Group (BILAG) A or B, unless within the constitutional, musculoskeletal and/or mucocutaneous domains
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986256
干预措施: BMS-986256 (Drug)
Placebo
干预措施: BMS-986256 Placebo (Other)
结局指标
主要结局
Incidence of Serious Adverse Events (SAEs)
时间窗: Up to 24 weeks
Incidence of Adverse Events (AEs)
时间窗: Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
时间窗: Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
时间窗: Up to 20 weeks
Number of laboratory test abnormalities: Hematology
时间窗: Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
时间窗: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
时间窗: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
时间窗: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
时间窗: Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
时间窗: Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
时间窗: Up to 20 weeks
次要结局
- Maximum observed plasma concentration (Cmax) of BMS-986256(Up to 20 weeks)
- Time to maximum concentration (Tmax) of BMS-986256(Up to 20 weeks)
- Trough observed plasma concentration (Ctrough) of BMS-986256(Up to 20 weeks)
- Area under the concentration-time curve over the dosing interval (AUC (TAU)) of BMS-986256(Up to 20 weeks)
- Maximum observed plasma concentration (Cmax) of metabolite BMT-271199(Up to 20 weeks)
- Time to maximum concentration (Tmax) of metabolite BMT-271199(Up to 20 weeks)
- Trough observed plasma concentration (Ctrough) of metabolite BMT-271199(Up to 20 weeks)
- Area under the concentration-time curve over the dosing interval (AUC (TAU)) of metabolite BMT-271199(Up to 20 weeks)