A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Non-Pustular PalmoPlantar and Genital Psoriasis (Psoriatyk Special Sites)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 130
- 试验地点
- 62
- 主要终点
- Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction
研究概览
简要总结
The purpose of this study is to measure the safety and effectiveness of deucravatinib in participants with non-pustular palmoplantar psoriasis and genital 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
- •Inclusion Criteria for Non-Pustular Palmoplantar Psoriasis
- •Men and women diagnosed with stable plaque psoriasis with involvement of the palm(s)and/or sole(s) for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
- •Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day
- •Moderate-to-severe non-pustular PP psoriasis, defined as pp-PGA score of ≥ 3 on a 5-pointscale and pp-PASI ≥ 8 at both screening visit and Day
- •A total maximum of 5 sterile pustules across both palms and soles limited only to psoriatic plaques will be allowed.
- •Evidence of typical plaque psoriasis outside palms and soles at both screening visit and Day
- •Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
- •Failed to respond to, or intolerant of ≥ 1 topical therapy.
- •Inclusion Criteria for Genital Psoriasis
- •Men and women diagnosed with stable plaque psoriasis with involvement of the genital area for at least 6 months or more. Stable psoriasis is defined as no morphology changes or significant flares of disease activity in the opinion of the investigator.
- •Moderate-to-severe plaque psoriasis defined as s-PGA score of ≥ 3 on a 5-point scale at both screening visit and Day
- •Moderate-to-severe GenPs, defined as static Physician's Global Assessment of Genitalia (s-PGA-G) score of ≥ 3 on a 6-point scale at both screening visit and Day
- •Evidence of typical plaque psoriasis in a non-genital area at both screening visit and Day
- •Deemed by the investigator to be a candidate for phototherapy or systemic therapy.
- •Failed to respond to, or intolerant of ≥ 1 topical therapy.
排除标准
- •Target Disease Exceptions
- •Has non-plaque psoriasis (for PP pustulosis, PP pustular psoriasis, isolated pustules on palms or soles with or without erythema outside psoriatic plaques, guttate, pustular, erythrodermic, and drug-induced psoriasis) at screening or Day
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Deucravacitinib
干预措施: Deucravacitinib (Drug)
Placebo followed by Deucravacitinib
干预措施: Deucravacitinib (Drug)
Placebo followed by Deucravacitinib
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Static Physician Global Assessment Genitals (s-PGA-G) Score of 0 (Clear ) or 1 (Almost Clear), With At Least a 2-Point Reduction
时间窗: Baseline to Week 16
Number of Participants With a 75% Improvement in Palmoplantar Psoriasis Area and Severity Index (pp-PASI-75) Score
时间窗: Baseline to Week 16
Percentage of Participants Achieving Palmoplantar Psoriasis Area and Severity Index (Pp-PASI)-75 Response
时间窗: Week 16
PASI-75 is defined as the percentage of participants who achieve at least a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) total score. PASI assesses erythema, thickness, and scaling of psoriatic lesions (each rated 0-4), weighted by body region involvement (head, arms, trunk, legs), producing a total score from 0-72, where higher scores indicate more severe disease. Baseline is the Week 0 assessment. PASI-75 responder defined as a 75% improvement from baseline in the PASI score.
Percentage of Participants Achieving Static Physician's Global Assessment of Genitalia (sPGA-G) Response
时间窗: Week 16
The Static Physician's Global Assessment (sPGA) OF Genitalia is a 5-point scale evaluating psoriasis severity based on erythema, scale, and induration. Scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe; higher scores indicate worse disease. The sPGA-G 0/1 response is defined as the percentage of participants achieving a score of 0 or 1 with at least a 2-point improvement from baseline.
次要结局
- Number of Participants With Palmoplantar Physician Global Assessment (pp-PGA) Score of 0 (Clear) or 1 (Almost Clear), With At Least a 2-Point Reduction(Baseline to Week 16)
- Number of Participants With Static Physician Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear), With Least a 2-Point Reduction(Baseline to Week 16)
- Number of Participants With Adverse Events (AEs)(Up to Week 16)
- Change from baseline in Genital Psoriasis (GenPs) Itch Numeric Rating Scale (NRS) score(Baseline to Week 16)
- Number of Participants With Serious Adverse Events (SAEs)(Up to Week 16)
- Number of Participants With Clinical Laboratory Abnormalities(Up to Week 16)
- Number of Participants With Vital Sign Abnormalities(Up to Week 16)
- Number of Participants With Vital Sign Summaries Per Categories(Week 0 through Week 16)
- Percentage of Participants Who Achieve a Palmoplantar Physician Global Assessment (Pp-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16(Week 16)
- Change From Baseline in Genital Psoriasis Itch (GenPs) Numeric Rating Scale (NRS) Score at Week 16(Week 16)
- Number of Participants With Adverse Events(Week 0 through Week 16)
- Number of Participants With Worst Toxicity Grade 3 or Grade 4 Laboratory Test Results(Week 0 through Week 16)