NCT05478499已完成4 期
A Phase 3B/4, Multicenter, Randomized, Double-blind Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Moderate-to-severe Scalp Psoriasis (PSORIATYK SCALP)
Bristol-Myers Squibb29 个研究点 分布在 5 个国家目标入组 154 人开始时间: 2022年10月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 29
- 主要终点
- Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.
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
- Double (Participant, Investigator)
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
- •Men and women diagnosed with stable plaque psoriasis with scalp involvement for 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the Investigator
- •Deemed by the Investigator to be a candidate for phototherapy or systemic therapy
- •Moderate-to-severe scalp psoriasis as defined by scalp-specific Physician's Global Assessment (ss-PGA) ≥ 3; ≥ 20% scalp surface area (SSA); Psoriasis Scalp Severity Index (PSSI) ≥ 12 at the Screening visit and Day 1
- •≥ 3% of Body Surface Area (BSA) involvement at the Screening visit and Day 1
- •Evidence of plaque psoriasis in a non-scalp area
- •Failed to respond to, or intolerant of ≥ 1 topical therapy for scalp psoriasis
排除标准
- •Target Disease Exceptions:
- •Has nonplaque psoriasis (ie, guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at Screening or Day 1 Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Deucravacitinib
Experimental
干预措施: Deucravacitinib (Drug)
Placebo then Deucravacitinib
Placebo Comparator
干预措施: Deucravacitinib (Drug)
Placebo then Deucravacitinib
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16
时间窗: Baseline and Week 16
ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease.
次要结局
- Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16(Baseline and Week 16)
- Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16(Baseline and Week 16)
- Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16(Baseline and Week 16)
- Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs)(From week 0 through week 16)
- Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs)(From week 0 through week 16)
- Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade(Week 0 through Week 16)
- Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests(Week 0 through Week 16)
- Number of Participants With Abnormalities in Vital Signs(Week 0 through Week 16)
研究者
研究点 (29)
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