NCT07000630终止不适用
Efficacy and Tolerability of Deucravacitinib in the Management of Palmoplantar Pustulosis; A Nonrandomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Primary efficacy endpoint
研究概览
简要总结
The goal of this clinical trial is to investigate the efficacy and safety of Deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis. Approximately 25 subjects will be included in the study and receive Deucravacitinib 6mg per day for four months. This study will begin June 2025 and is expected to last 14 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between ages 18 - 65 years who have suffered from palmoplantar pustulosis (PPP) for at least 6 months.
- •Patients were required to have over 10 well-demarcated white or yellow pustules across all regions, with or without plaque psoriasis
- •Patients were required to have a Palmoplantar Pustular Physician's Global Assessment (PPPGA) score of at least moderate severity (≥3) and a minimum PPPASI score of
- •Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
- •Further criteria apply.
排除标准
- •Systemic treatment for PPP ended less than five half-lives or 12 weeks ago
- •Topical treatment for PPP ended less 4 weeks ago
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
- •Severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.
- •Presence or known history of anti-TNF-induced PPP-like disease.
- •Patient with a transplanted organ (with exception of a corneal transplant >12 weeks Prior to screening) or who have ever received stem cell therapy.
- •Known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- •Further criteria apply.
研究组 & 干预措施
Deucravacitinib treatment
Experimental
25 subjects with palmoplantar pustulosis will be allocated to receive oral Deucravacitinib 6mg everyday for 16 weeks.
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Primary efficacy endpoint
时间窗: From enrollment to the end of treatment at 16 weeks
The primary efficacy endpoint was percentage change from baseline in Palmoplantar Pustular Area and Severity Index (PPPASI) at W16.
次要结局
- Effect of Deucravacitinib on overall severity of palmoplantar pustulosis(From enrollment to the end of treatment at 16 weeks)
- Effect of Deucravacitinib on quality of life: Dermatology Life Quality Index (DLQI)(From enrollment to the end of treatment at 16 weeks)
研究者
Jingru Sun
Attending doctor
Peking University First Hospital
研究点 (1)
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