NCT03587194已完成4 期
A Single Center Study to Evaluate the Effectiveness and Safety of Add on Enstilar® in Patients Using OTEZLA® for Moderate to Severe Plaque Psoriasis
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年7月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Psoriasis Area Severity Index 75 at Week 12
研究概览
简要总结
Add-on Enstilar to Otezla therapy.
详细描述
50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 16 weeks with add-on Enstilar.
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 —（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:
- •PGA score of 3 or greater
- •BSA affected by plaque-type psoriasis of 10% or greater
- •PASI ≥ 12
- •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. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
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
- •Subjects who previously used any biologic agent for psoriasis.
- •Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
- •Patient used topical therapies to treat psoriasis on the hands and/or feet within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
- •Patient received UVB phototherapy within 2 weeks of Baseline.
研究组 & 干预措施
Otezla Enstilar
Experimental
Otezla 30mg BID Enstilar QD
干预措施: Otezla (Drug)
结局指标
主要结局
Psoriasis Area Severity Index 75 at Week 12
时间窗: 12 weeks
Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)
次要结局
未报告次要终点
研究者
研究点 (1)
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