A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986326 in Adult Participants With Discoid Lupus Erythematosus, Subacute Cutaneous Lupus Erythematosus, or Systemic Lupus Erythematosus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 44
- 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 safety, drug levels and drug effects on cells and organs of the body, after receiving multiple increasing doses of BMS-986326 via intravenous (IV) infusion or subcutaneous (SC) injection, in participants with different forms of lupus.
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
- •Having a diagnosis of Discoid Lupus Erythematosus (DLE), Subacute Cutaneous Lupus Erythematosus (SCLE), or Systemic Lupus Erythematosus (SLE).
- •Participants with DLE or SCLE must have their diagnosis at least 3 months prior to screening and must be confirmed by biopsy (except if only the facial/head/neck region is affected) and must have some ongoing disease activity (based CLASI-A scoring).
- •Participants with SLE must have a diagnosis of SLE at screening based on the 2019 EULAR/ACR Classification for SLE and have mild-moderate disease severity (based on a SLEDAI-2K score).
排除标准
- •SLE that is considered by the Investigator to be severe.
- •Drug-induced CLE and drug-induced SLE.
- •Women who are pregnant or breastfeeding.
- •Current use of >10 mg prednisone (or equivalent) per day.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Cohort D2: BMS-986326 Dose 4 SC
干预措施: Placebo for BMS-986326 (Other)
Cohort E2: BMS-986326 Dose 3 SC
干预措施: BMS-986326 (Drug)
Cohort D2: BMS-986326 Dose 4 SC
干预措施: BMS-986326 (Drug)
Cohort A: BMS-986326 Dose 1 IV
干预措施: BMS-986326 (Drug)
Cohort B: BMS-986326 Dose 2 IV
干预措施: BMS-986326 (Drug)
Cohort C1: BMS-986326 Dose 3 IV
干预措施: BMS-986326 (Drug)
Cohort C2: BMS-986326 Dose 3 SC
干预措施: BMS-986326 (Drug)
Cohort A: BMS-986326 Dose 1 IV
干预措施: Placebo for BMS-986326 (Other)
Cohort B: BMS-986326 Dose 2 IV
干预措施: Placebo for BMS-986326 (Other)
Cohort C1: BMS-986326 Dose 3 IV
干预措施: Placebo for BMS-986326 (Other)
Cohort C2: BMS-986326 Dose 3 SC
干预措施: Placebo for BMS-986326 (Other)
Cohort E2: BMS-986326 Dose 3 SC
干预措施: Placebo for BMS-986326 (Other)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 228 days
Number of participants with serious adverse events (SAEs)
时间窗: Up to 228 days
Number of participants with clinical laboratory abnormalities
时间窗: Up to 228 days
Number of participants with vital sign abnormalities
时间窗: Up to 228 days
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to 228 days
Number of participants with physical examination abnormalities
时间窗: Up to 228 days
次要结局
- Maximum observed serum concentration (Cmax)(Predose and post-dose up to Day 167)
- Time of Cmax (Tmax)(Predose and post-dose up to Day 167)
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])(Predose and post-dose up to Day 167)
- Change from baseline in regulatory T cells (Treg) count to Day 144(Baseline up to Day 144)
- Change from baseline in Treg-to-conventional t cells (Tconv) ratio(Baseline up to Day 144)
- Number of participants with anti-drug antibodies(Baseline up to Day 167)
- Maximum observed serum concentration (Cmax)(Predose and post-dose up to Day 167)
- Time of Cmax (Tmax)(Predose and post-dose up to Day 167)
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])(Predose and post-dose up to Day 167)
- Serum PK parameters such as AUC(TAU)(Predose and post-dose up to Day 167)
- Change from baseline in regulatory T cells (Treg) count to Day 144(Baseline up to Day 144)
- Change from baseline in Treg-to-conventional t cells (Tconv) ratio(Baseline up to Day 144)
- Number of participants with anti-drug antibodies(Baseline up to Day 167)