A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects With Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 98
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
研究概览
简要总结
The main objective of the trial is to characterize the long-term safety and tolerability of BMS-986165 in subjects with Systemic Lupus Erythematosus (SLE).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completion of SLE Study (NCT03252587) through the protocol-required treatment period, and currently receiving blinded study drug. Note: If a subject is not receiving blinded study drug due to exceptional circumstances (eg, missed investigational product [IP] due to COVID-19 pandemic, delays in study approval, etc), the subject may be allowed to enroll with approval from the BMS Clinical Trial Physician or designee.
排除标准
- •Any disease or medical condition that, in the opinion of the investigator, would make the subject unsuitable for this study, would interfere with the interpretation of subject safety or study results, or considered unsuitable by the investigator for any other reason
- •Evidence of active tuberculosis (TB)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986165 Dose 1
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 2
干预措施: BMS-986165 (Drug)
BMS-986165 Dose 3
干预措施: BMS-986165 (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
时间窗: From Day 1 until 30 days after last dose (up to approximately 42 months)
A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
Number of Participants With Abnormalities in Vital Signs
时间窗: From Day 1 until 30 days after last dose (up to approximately 42 months)
Vital signs heart rate (HR) (beats/min), systolic blood pressure (SBP) (mmHG), and diastolic blood pressure (DBP) (mmHg).
Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
时间窗: From Day 1 until 30 days after last dose (up to approximately 42 months)
Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality
次要结局
未报告次要终点