NCT07672561招募中3 期
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Study to Evaluate the Efficacy and Safety of WD-890 Tablets for the Treatment of Moderate to Severe Plaque Psoriasis
Zhejiang Wenda Pharma Technology LTD.1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2026年3月18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
- 招募中
- 发起方
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 16
研究概览
简要总结
The purpose of the study is to evaluate the experimental medication WD-890 compared to placebo in participants with moderate-to-severe plaque 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participant aged 18 to 75 years(inclusive)at the time of informed consent.
- •Diagnosis of plaque psoriasis for at least 6 months prior to the screening visit.
- •Body surface area (BSA) ≥10%, Psoriasis Area and Severity Index (PASI) score ≥12 and static Physician's Global Assessment (sPGA) ≥3 at screening visit and randomization
排除标准
- •Participant has a nonplaque form of psoriasis (for example, erythrodermic, guttate, inverse, pustular,or drug induced psoriasis.)
- •Has uncontrolled arterial hypertension characterized by a systolic blood pressure (BP) ≥160 mm Hg or diastolic BP ≥100 mm Hg Note: Determined by 2 consecutive elevated readings. If an initial BP reading exceeds this limit, the BP may be repeated once after the subject has rested sitting for ≥10 minutes. If the repeat value is less than the criterion limits, the second value may be accepted
- •Class III or IV congestive heart failure by New York Heart Association Criteria
研究组 & 干预措施
Group 1:WD-890
Experimental
Drug:WD-890
WD-890 tablet will be administered orally.
干预措施: Drug:WD-890 (Drug)
Group 2: Placebo
Placebo Comparator
Drug: Placebo
Placebo tablet will be administered orally.
干预措施: Drug: placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 16
时间窗: Screening up to Week 16
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 75 Score at Week 16
时间窗: Screening up to Week 16
次要结局
- Percentage of Participants Who Achieved Physician's Global Assessment (PGA) Score of Clear (0) or Almost Clear (1) at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.(Screening up to Week 52)
- Percentage of Participants Achieving PASI 90 Score at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.(Screening up to Week 52)
- Percentage of Participants Achieving PASI 100 Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.(Screening up to Week 52)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at at Weeks 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, and 52.(Screening up to Week 52)
研究者
研究点 (1)
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