Tyrosine Kinase 2 (TYK2) Inhibition in Paradoxical Psoriasis A Randomized, Double-blind, Placebo-controlled Multi-center Study Evaluating the Effect of Deucravacitinib on Severity of Psoriasis in Patients With Paradoxical Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Paradoxical Psoriasis Investigator Global Assessment
研究概览
简要总结
Paradoxical psoriasis is a side effect of a biological treatment (anti-tumor necrosis factor agent, short called anti-TNF) that is used to treat diseases of the skin, the intestine or the joints. If paradoxical psoriasis occurs, the anti-TNF-treatment often needs to be stopped and so far, no specific treatment for paradoxical psoriasis exists.
This research project aims to study whether the efficacy of the drug 'Deucravacitinib' 6mg, a tablet taken by mouth once a day is superior compared to taking a placebo in treating paradoxical 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)
盲法说明
Lab personnel
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
- •Clinical diagnosis of Paradoxical Psoriasis caused by anti-TNF treatment, with with Investigator Global Assessment ≥ 2 and Body Surface Area ≥ 2%
- •Females who are of child-bearing potential should be practicing highly-effective contraception methods throughout the study and for 28 days after the last dose of study drug;
- •Male subjects with a mechanical contraceptive method;
- •be in good health
- •be willing to have skin biopsies taken
排除标准
- •Use of any other anti-psoriatic therapy. Certain washout periods of treatments needs to be respected
- •Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the Baseline visit;
- •A positive serology test for hepatitis B, hepatitis C, HIV;
- •History of lymphoproliferative disease or of malignancy within the past 5 years.
- •Chronic recurring bacterial infections or active tuberculosis;
- •Positive pregnancy test at Screening and at the Baseline visit;
- •Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
- •History of clinically significant alcohol or drug abuse in the last 12 months
- •Known hypersensitivity to Deucravacitinib or any of its excipients
- •Current severe progressive or uncontrolled disease
- •Live vaccine within 12 weeks before Baseline Visit.
研究组 & 干预措施
'Deucravacitinib'
Deucravacitinib 6mg oral intake once daily for 4 weeks
干预措施: Deucravacitinib (Drug)
'Placebo'
Matching Placebo oral intake once daily for 4 weeks
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Paradoxical Psoriasis Investigator Global Assessment
时间窗: At Week 4
Percentage of patients attaining PxP IGA 0/1 and at least a reduction of 2 points from baseline
次要结局
- Paradoxical Psoriasis Body Surface Area(At Week 4)
- Paradoxical Psoriasis palmoplantar Psoriasis Area and Severity Index(at 4 Weeks)
- Paradoxical Psoriasis Scalp Investigator General Assessment(At Week 4)
- Psoriasis Area and Severity Index (PASI)(At Week 4 and at Week 16)
- American College of Rheumatology (ACR) Score(At Week 4 and Week 16)
研究者
Prof Curdin Conrad
Associate Professor
Centre Hospitalier Universitaire Vaudois