NCT04347473招募中4 期
A Single Center Study to Evaluate the Effectiveness and Safety of ILUMYA in Combination With HALOG Ointment 0.1% for the Treatment of 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 25 人开始时间: 2020年4月6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
研究概览
简要总结
Patient with moderate-to-severe plaque psoriasis will receive Ilumya with or without Halog ointment.
详细描述
25 adult subjects with moderate to severe plaque psoriasis will receive Ilumya 100mg subcutaneously at weeks 0, 4 and 16.
At week 16, patients with remaining BSA ˃3% will be given HALOG ointment 0.1% to apply BID for 4 weeks. Patients who have ≤3% BSA at week 16 will remain on Ilumya monotherapy.
Patients will continue to be evaluated at weeks 20 and 24.
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 moderate-to-severe chronic plaque-type psoriasis as defined by
- •Must be a candidate for phototherapy and/or systemic therapy
- •Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at 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.
排除标准
- •Non-plaque forms of psoriasis
- •Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
- •Presence of significant uncontrolled medical condition that in the opinion of the investigator would affect patient safety during the trial.
- •Active or untreated latent tuberculosis (TB)
研究组 & 干预措施
Ilumya
Experimental
Ilumya 100mg subcutaneous at weeks 0, 4 and 16.
干预措施: Ilumya Injectable Product (Drug)
结局指标
主要结局
Body surface area
时间窗: 16 weeks
evaluation of body surface area percentage affected by psoriasis where 1 palm is equivalent to 1%
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque PsoriasisPsoriasisNCT01206387Taro Pharmaceuticals USA120
终止
不适用
An Explorative Psoriasis Biomarker StudyPsoriasis VulgarisNCT04394936Centre for Human Drug Research, Netherlands37
已完成
不适用
A Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)Moderate Plaque PsoriasisNCT03059953Genesis Pharma S.A.302
Unknown
4 期
Brodalumab in Palmoplantar PsoriasisPalmoplantar PsoriasisNCT04622033First OC Dermatology10
已完成
3 期
The Purpose of This Study is to Demonstrate the Safety and Effectiveness of Calcipotriene Foam in Subjects With Scalp and Body PsoriasisPsoriasisNCT01139580Stiefel, a GSK Company363