2023-504161-22-00招募中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)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 8
- 主要终点
- Percentage change from baseline in CLASI activity (CLASIA) score
研究概览
简要总结
To evaluate the effect of two doses of deucravacitinib (3 mg BID and 6 mg BID) compared with placebo on CLASI-A score at Week 16
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must have a diagnosis of DLE/SCLE
- •Cutaneous Lupus Erythematosus Disease Area and Severity Index- Activity (CLASI-A) score ≥ 8
- •Participants must currently be receiving stable treatment regimen for CLE
- •For optional long term extension treatment period: Completion of Study IM011132 through the protocol-required active treatment period (ie up to and including week 52 treatment visit).
- •For optional long-term extension treatment period: Participant is, based on the invesigators medical judgement, likely to receive benefit from receiving treatment with deucravacitinib.
排除标准
- •Participants with forms of drug-induced CLE and/or drug-induced SLE
- •Participants with other non-SLE driven inflammatory conditions that will significantly impact the assessment of CLE/SLE disease manifestations and activity
结局指标
主要结局
Percentage change from baseline in CLASI activity (CLASIA) score
Percentage change from baseline in CLASI activity (CLASIA) score
次要结局
- Percentage of participants with an improvement of ≥ 50% from baseline in the CLASI-A score (CLASI-50)
- Percentage of participants who have disease improvement as defined by a reduction in CLASI-A of ≥ 4 points from baseline
- Mean change from baseline in CLASI-A score
- Percentage of participants who have a Complete Response (CR) on CLASI-A defined as a score of "0"
- Number and proportion of participants experiencing SAEs, AEs (with severity and relationship of AEs), and abnormalities in laboratory testing, vital signs, and 12-lead ECGs
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (8)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic DrugsPsoriatic ArthritisNCT04908202Bristol-Myers Squibb650
进行中（未招募）
3 期
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusNCT05617677Bristol-Myers Squibb516
进行中（未招募）
3 期
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus ErythematosusSystemic Lupus ErythematosusNCT05620407Bristol-Myers Squibb513
进行中（未招募）
3 期
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's SyndromeSjögren's SyndromeNCT05946941Bristol-Myers Squibb774
已完成
4 期
Efficacy and Safety of Deucravacitinib Versus Placebo in Participants With Moderate-to-severe Scalp PsoriasisPsoriasisNCT05478499Bristol-Myers Squibb154