jRCTs041240089招募中不适用
Investigation of the usefulness of deucravacitinib in early onset psoriasis
未提供0 个研究点目标入组 100 人开始时间: 2025年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 主要终点
- Percentage achieving PASI >= 90 or PASI score <=1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit(—)
- 性别
- All
入选标准
- •Psoriasis vulgaris patients over 18 years old
- •Patients with psoriasis vulgaris less than 2 years or more than 10 years after onset
- •Patients who have given a written explanation of the study and obtained written consent to participate in the study.
- •Patients who fulfill any of the following (1)~(3)
- •(1)Patients who do not respond adequately to existing systemic therapies, including phototherapy, and whose skin rash covers more than 10% of their body surface area
- •(2)Patients with severely impaired quality of life: DLQI > 10
- •(3)Patients with refractory skin rashes:
- •Patients with skin rash on difficult-to-treat areas (scalp, palms, soles, genitalia, etc.) and PASI 5 or higher
排除标准
- •Patients who have been treated with multiple biologics(However, only one type of experience in the use of biological products is acceptable for registration.)
- •Patients who have been previously treated with the investigational drug deucravacitinib and were unable to continue treatment for safety or other reasons
- •Patients with serious infections and active tuberculosis
- •Patients with a history of hypersensitivity to any component of the drugs under study
- •Patients who have participated or are participating in a clinical trial within the past 6 months
- •Patients deemed ineligible by the physician in charge
结局指标
主要结局
Percentage achieving PASI >= 90 or PASI score <=1
时间窗: 24 weeks of treatment
Patients with psoriasis less than 2 years after onset (Group A) vs. patients with psoriasis more than 10 years after onset (Group B)
次要结局
- Duration of remission and maintenance rate
- Trends and changes in index scores
- PASI >=90 or PASI score =<1 maintenance
- Changes in concomitant medications
- Exploratory study items
研究者
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