NCT04372277招募中4 期
Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年4月28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
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Body Surface Area 0 or 1
研究概览
简要总结
Enstilar in combination with Taltz for plaque psoriasis.
详细描述
A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.
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
- •Body Surface Area between 3%-8%.
- •Patient has been treated with Taltz for a minimum of 24 weeks
- •Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- •Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination
- •Able and willing to give written informed consent prior to performance of any study-related procedures.
- •Exclusion Criteria
- •˂3% or >8% BSA
- •Patient not receiving Taltz, or receiving Taltz <24 weeks
- •Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
- •Pregnant or breast feeding, or considering becoming pregnant during the study.
- •Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- •Use of oral systemic medications for the treatment of psoriasis within 4 weeks.
- •Patient used other topical therapies to treat within 2 weeks of the Baseline Visit.
- •Patient received UVB phototherapy within 2 weeks of Baseline.
- •Patient received PUVA phototherapy within 4 weeks of Baseline.
- •Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
排除标准
- 未提供
研究组 & 干预措施
Enstilar
Experimental
Enstilar foam
干预措施: Enstilar (Drug)
结局指标
主要结局
Body Surface Area 0 or 1
时间窗: 4 weeks
Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1.
次要结局
未报告次要终点
研究者
研究点 (1)
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