A Single Center Study to Evaluate the Effectiveness and Safety of SOTYKTU® (Deucravacitinib) in Combination With Enstilar® for Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psoriasis Area and Severity Index 75 at week 12
研究概览
简要总结
combination deucravacitinib and enstilar foam
详细描述
30 adult patients with moderate to severe plaque psoriasis will be given Deucravacitinib 6mg QD for the first 8 weeks of the study.
At week 8:
Subjects who do not meet PASI 25 at week 8 will be discontinued from the study as non-responders.
Subjects who achieve ≥PASI 75 at week 8 will remain enrolled and continue Deucravacitinib 6mg QD monotherapy through week 24.
Subjects who achieved between PASI 25-74 response will receive 4 weeks of Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% applied QD in addition to continuing Deucravacitinib 6mg QD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult ≥ 18 years of age;
- •Diagnosis of chronic plaque-type psoriasis
- •Moderate to severe plaque type psoriasis as defined at baseline by:
- •BSA affected by plaque-type psoriasis of 10% or greater
- •PGA score of 3 or greater
- •Able and willing to give written informed consent prior to performance of any study-related procedures Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.
排除标准
- •Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
- •Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis
- •Use of oral systemic medications or PUVA phototherapy for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
- •Prior use of biologics within the following periods:
- •Etanercept - 4 weeks
- •Adalimumab or certolizumab pegol - 8 weeks
- •IL-17 antagonists - 16 weeks
- •Ustekinumab or IL-23 pathway inhibitors - 24 weeks
- •Other biologics - 5 half-lives
- •Patient used topical therapies or UVB phototherapy to treat psoriasis within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
研究组 & 干预措施
Deucravacitinib in combination with Enstilar
deucravacitinib in combination with Enstilar
干预措施: Enstilar (Drug)
Deucravacitinib in combination with Enstilar
deucravacitinib in combination with Enstilar
干预措施: Deucravacitinib (Drug)
Deucravacitinib monotherapy
monotherapy
干预措施: Deucravacitinib (Drug)
结局指标
主要结局
Psoriasis Area and Severity Index 75 at week 12
时间窗: 12 weeks
Proportion of subjects achieving PASI 75 at week 12 for patients in the Deucravacitinib + Enstilar combination arm.
次要结局
未报告次要终点