NCT04857034进行中（未招募）2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
Bristol-Myers Squibb41 个研究点 分布在 8 个国家目标入组 74 人开始时间: 2021年7月12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
- 进行中（未招募）
- 发起方
- 入组人数
- 74
- 试验地点
- 41
- 主要终点
- Percentage Change From Baseline in CLASI Activity Score at Week 16
研究概览
简要总结
The purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (BMS-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (DLE/SCLE). This study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe DLE/SCLE with or without systemic lupus erythematosus (SLE) that is not well controlled with standard of care therapy.
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
- •Diagnosis of discoid/subacute cutaneous lupus erythematosus (DLE/SCLE) for at least 3 months prior to screening visit
- •Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
- •Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant
- •Participant could be with or without concurrent systemic lupus erythematosus (SLE)
- •If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening
排除标准
- •Women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period
- •Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
- •Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
- •Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
- •History of 3 or more unexplained consecutive pregnancy losses
- •Active severe or unstable neuropsychiatric SLE
- •Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Active Treatment: Deucravacitinib Dose 1
Experimental
干预措施: Deucravacitinib (Drug)
Active Treatment: Deucravacitinib Dose 2
Experimental
干预措施: Deucravacitinib (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage Change From Baseline in CLASI Activity Score at Week 16
时间窗: From first dose to Week 16 (approximately 16 weeks)
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70
次要结局
- Percentage of Participants With an Improvement of ≥ 50% From Baseline in the CLASI-A Score (CLASI-50).(From first dose to Week 16 (approximately 16 weeks))
- Percentage of Participants Who Have Disease Improvement as Defined by a Reduction in CLASI-A of ≥ 4 Points From Baseline.(From first dose to Week 16 (approximately 16 weeks))
- Mean Change From Baseline in CLASI-A Score.(From first dose to Week 16 (approximately 16 weeks))
- Percentage of Participants Who Have a Complete Response (CR) on CLASI-A Defined as a Score of "0".(From first dose to Week 16 (approximately 16 weeks))
- Number of Participants With Safety Related Events in the Placebo Controlled Period(From signing informed consent to end of safety follow up period (Approximately 60 weeks))
- Number of Participants With Safety Related Events in the Active Treatment Period(From signing informed consent to end of safety follow up period (Approximately 60 weeks))
- Number of Participants With Clinically Significant Laboratory Abnormalities in the Placebo Controlled Period(From signing informed consent to end of safety follow up period (Approximately 60 weeks))
- Number of Participants With Clinically Significant Laboratory Abnormalities in the Active Treatment Period(From signing informed consent to end of safety follow up period (Approximately 60 weeks))
- Number of Participants With Clinically Significant Vital Sign Abnormalities in the Placebo Controlled Period(From signing informed consent to end of safety follow up period (Approximately 60 weeks))
- Number of Participants With Clinically Significant Vital Sign Abnormalities in the Active Treatment Period(From signing informed consent to end of safety follow up period (Approximately 60 weeks))
- Number of Participants With Clinically Significant ECG Abnormalities in the Placebo Controlled Period(From signing informed consent to end of active treatment period (Approximately 56 weeks))
- Number of Participants With Clinically Significant ECG Abnormalities in the Active Treatment Period(From signing informed consent to end of active treatment period (Approximately 56 weeks))
研究者
研究点 (41)
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