A Phase 3, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-279 in Adult Subjects With Generalized Pustular Psoriasis or Erythrodermic Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 40
- 主要终点
- Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16
研究概览
简要总结
The main aim of this study is to check if TAK-279 improves symptoms of With Generalized Pustular Psoriasis (GPP) or Erythrodermic Psoriasis (EP) and side effect from the study treatment or TAK-279.
All participants will be assigned to study treatments of TAK-279 and will be treated with TAK-279 if the participants meet the study rules.
Participants will be in the study for up to 61 weeks including 52 weeks of study treatment. During the study, participants will visit their study clinic for multiple times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •A diagnosis of GPP or EP prior to the screening visit.
- •Candidate for phototherapy or systemic therapy.
排除标准
- •Other forms of psoriasis.
- •History of recent infection.
- •Any prior exposure to TAK-279, or participation in any study that included a TYK2 inhibitor.
- •Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
TAK-279 for Generalized Pustular Psoriasis
Participants with generalized pustular psoriasis will receive TAK-279 from Day 1 up to Week 52.
干预措施: TAK-279 (Drug)
TAK-279 for Erythrodermic Psoriasis
Participants with erythrodermic psoriasis will receive TAK-279 from Day 1 up to Week 52.
干预措施: TAK-279 (Drug)
结局指标
主要结局
Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 16
时间窗: Baseline, Week 16
The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scaling, and induration. The average of the 3 scales, rounded to the nearest whole number, is the final sPGA score. The sPGA score ranges from 0 to 4 (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe). Higher scores indicate more severe disease activity. 'Clear' and 'Almost clear' will include all participants who score a 0 or 1.
Percentage of Participants Achieving ≥75% Improvement from Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 16
时间窗: Baseline, Week 16
PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. Percentage of participants showing at least 75% improvement in PASI score relative to baseline PASI score will be reported.
次要结局
- Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Week 52(Baseline, Week 52)
- Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Both Week 16 and Week 52 Visits(Baseline, Week 16 and Week 52)
- Percentage of Participants Achieving an sPGA of Clear (0) at Week 16 and Week 52(Week 16 and Week 52)
- Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52(Week 16 and Week 52)
- Percentage of Participants Achieving an sPGA of Clear (0) or Almost Clear (1) at Week 16 and Week 52 Visits(Week 16 and Week 52)
- Percentage of Participants Achieving PASI-75 at Week 52(Week 52)
- Percentage of Participants Achieving PASI-90 at Week 16 and Week 52(Week 16 and Week 52)
- Percentage of Participants Achieving PASI-100 at Week 16 and Week 52(Week 16 and Week 52)
- Percentage of Participants Achieving PASI-75 at Both the Week 16 and Week 52 Visits(Week 16 and Week 52)
- Percentage of Participants Achieving PASI-90 at Both the Week 16 and Week 52 Visits(Week 16 and Week 52)
- Percentage of Participants Achieving a Scalp-specific Physician's Global Assessment (ssPGA) of Absence of Disease (0) or Very Mild Disease (1) With a ≥2-Point Decrease from Baseline at Week 16 and Week 52(Week 16 and Week 52)
- Change from baseline in ssPGA at Weeks 16 and 52(Baseline, Week 16 and Week 52)
- Percentage of Participants Achieving a PGA of the Hands and/or Feet of Clear (0) or Almost Clear (1) With a ≥2-Point Decrease from Baseline at Weeks 16 and Week 52(Baseline, Week 16 and Week 52)
- Percentage of Participants with a Baseline Dermatology Life Quality Index (DLQI) Score ≥2 who Achieve DLQI Score of 0 or 1 at Week 16 and Week 52(Week 16 and Week 52)
- Change from Baseline in DLQI at Week 16 and Week 52(Baseline, Week 16 and Week 52)
- Change from Baseline in Nail Psoriasis Severity Index (NAPSI) at Week 16 and Week 52 Among Participants with Nail Involvement at Baseline(Baseline, Week 16 and Week 52)
- Change from Baseline in Body Surface Area (BSA) Affected by Psoriasis at Week 16 and Week 52(Baseline, Week 16 and Week 52)
- Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a Generalized Pustular Psoriasis Global Assessment (GPPGA) Pustulation Subscore of No Visible Pustules (0) at Week 16 and Week 52(Week 16 and Week 52)
- Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) or Almost Clear (1) at Weeks 16 and Week 52(Week 16 and Week 52)
- Percentage of Participants with Generalized Pustular Psoriasis Who Achieve a GPPGA of Clear (0) at Week 16 and Week 52(Week 16 and Week 52)
- Percentage of Participants with Generalized Pustular Psoriasis Who Achieve ≥75% Improvement from Baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI) Score at Week 16 and Week 52(Weeks 16 and Week 52)
- Change from Baseline in Japanese Dermatological Association Severity Index (JDASI) Score at Week 16 and Week 52 for Participants with Generalized Pustular Psoriasis(Week 16 and Week 52)