NCT05946941进行中（未招募）3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)
Bristol-Myers Squibb369 个研究点 分布在 5 个国家目标入组 774 人开始时间: 2023年9月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 774
- 试验地点
- 369
- 主要终点
- Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening.
- •Have moderate to severe SjS ESSDAI ≥
- •Short duration of disease (≤ 10 years) before screening.
- •A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
- •Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.
排除标准
- •Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus [SLE], systemic sclerosis).
- •Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered.
- •Medical condition associated with sicca syndrome.
- •Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Deucravacitinib, Dose 1
Experimental
干预措施: Deucravacitinib (Drug)
Deucravacitinib, Dose 2
Experimental
干预措施: Deucravacitinib (Drug)
Placebo, followed by Deucravacitinib Dose 1 or Dose 2
Placebo Comparator
干预措施: Deucravacitinib (Drug)
Placebo, followed by Deucravacitinib Dose 1 or Dose 2
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
时间窗: Baseline, Week 52
次要结局
- Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52(Baseline, Week 52)
- Number of participants with ESSDAI < 5 at Week 52(Baseline, Week 52)
- Change from baseline in stimulated whole salivary flow (SWSF) at Week 52(Baseline, Week 52)
- Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52(Baseline, Week 52)
- Change from baseline in oral dryness NRS at Week 52(Baseline, Week 52)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Week 156)
- Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52(Baseline, Week 52)
- Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52(Baseline, Week 52)
- Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52(Baseline, Week 52)
- Number of participants with AEs leading to discontinuation of treatment and study discontinuation(Up to Week 160)
- Number of participants with clinical laboratory abnormalities(Up to Week 160)
- Change from baseline in ESSDAI at Week 24(Baseline, Week 24)
- Change from baseline in physician global assessment (PhGA) at Week 52(Baseline, Week 52)
- Change from baseline in joint/ muscle pain NRS at Week 52(Baseline, Week 52)
- Number of participants with an increase of Schirmer's test ≥ 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal(Baseline, Week 52)
- Number of participants with adverse events (AEs)(Up to Week 160)
- Number of participants with serious AEs (SAEs)(Up to Week 160)
- Number of participants with AEs of special interest (AESIs)(Up to Week 160)
- Number of participants with vital sign abnormalities(Up to Week 160)
研究者
研究点 (369)
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