跳至主要内容
临床试验/jRCTs041240089
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

发起方
未提供

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