EUCTR2018-001216-29-SK进行中（未招募）1 期
A Phase 2a Study to Evaluate Safety, Tolerability, and Efficacy of PRCL-02 in Patients with Moderate to Severe Chronic Plaque Psoriasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male and female between 18 to 75 years of age inclusive.
- •- Present with moderate to severe psoriasis vulgaris based on the disease diagnostic criteria.
- •- Are candidates for systemic therapy.
- •- Have a body mass index (BMI) within the range of 18 to 40 kg/m2, inclusive.
- •- Women who are of childbearing potential, who must agree to use effective methods of contraception for the entirety of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 51
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Present with pustular, erythrodermic psoriasis, generalized pustular psoriasis or acute guttate psoriasis.
- •- Have current serious or unstable illnesses.
- •- Have received inactivated vaccine within 4 weeks prior to dosing in this study, or a live vaccine within 3 months prior to dosing in this study.
- •- Present with a history of clinically significant opportunistic infection.
- •- Had symptomatic herpes zoster within 3 months of randomization, other recent or ongoing infection
- •- Positive QuantiFERON®-tuberculosis test at screening AND have not been vaccinated for tuberculosis.
研究者
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