跳至主要内容
临床试验/NCT03943147
NCT03943147终止2 期

A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis

Bristol-Myers Squibb87 个研究点 分布在 6 个国家目标入组 16 人开始时间: 2019年7月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
16
试验地点
87
主要终点
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)

研究概览

简要总结

The purpose of this study is to evaluate the safety and effectiveness of BMS-986165 compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

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)

盲法说明

Double-blind Study

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

入选标准

  • Meets the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria for Systemic Lupus Erythematosus (SLE)
  • Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V
  • Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen

排除标准

  • Pure ISN/RPS Class V membranous LN
  • Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2
  • Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study
  • End-stage renal disease
  • Other protocol-defined inclusion/exclusion criteria apply

研究组 & 干预措施

BMS-986165 Dose 1

Experimental

Specified Dose on Specified Days

干预措施: BMS-986165 (Drug)

BMS-986165 Dose 1

Experimental

Specified Dose on Specified Days

干预措施: Mycophenolate Mofetil (Drug)

BMS-986165 Dose 2

Experimental

Specified Dose on Specified Days

干预措施: BMS-986165 (Drug)

BMS-986165 Dose 2

Experimental

Specified Dose on Specified Days

干预措施: Mycophenolate Mofetil (Drug)

Placebo for BMS-986165

Placebo Comparator

Specified Dose on Specified Days

干预措施: Placebo (Drug)

Placebo for BMS-986165

Placebo Comparator

Specified Dose on Specified Days

干预措施: Mycophenolate Mofetil (Drug)

Mycophenolate Mofetil (MMF)

Experimental

Specified Dose on Specified Days

干预措施: Mycophenolate Mofetil (Drug)

结局指标

主要结局

The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)

时间窗: From baseline up to 52 weeks after first dose in Part B

The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)

时间窗: From baseline up to 52 weeks after first dose in Part B

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)

时间窗: From baseline up to 52 weeks after first dose in Part B

The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)

时间窗: From baseline up to 52 weeks after first dose in Part B

The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.

Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)

时间窗: Week 24

The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.

次要结局

  • The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)(Week 52)
  • The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)(Week 52)
  • The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)(Week 24)
  • The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)(Week 24)
  • The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B)(Week 24)
  • The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B)(Week 52)

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (87)

Loading locations...

相似试验