EUCTR2018-001926-25-Outside-EU/EEA进行中（未招募）1 期
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BMS-986165 in Adolescent Subjects with Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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 females between 12 to less than 18 years of age
- •- diagnosed with stable (defined as no significant flares of disease activity or morphologic changes for 6 months) moderate to severe plaque psoriasis. Moderate to severe psoriasis defined by: (at screening visit and Day 1) Psoriasis Area and Severity Index (PASI) = 12, // static Physician’s Global Assessment (sPGA) = 3, // Body Surface Area (BSA) = 10% involvement
- •- candidates for phototherapy or systemic therapy
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 168
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Subject has non-plaque forms of psoriasis (e.g. erythrodermic, guttate, inverse or pustular)
- •2. Subjects weighing < 30 Kg at screening
- •3. Subject has any of the following TB criteria:
- •a) History of active TB prior to screening visit, regardless of completion of adequate treatment
- •b) Signs or symptoms of active TB during screening as judged by the investigator
- •c) A chest x-ray showing evidence of current active or old active pulmonary TB
- •d) Latent TB infection (LTBI) defined as positive IGRA (QuantiFERON-TB Gold) at screening
- •4. Received live vaccine within 60 days or plan to receive a live vaccine during the study or plan to receive live vaccine within 60 days of last dose of study medication
- •5. Currently being treated with biologic agents
- •6. History of ongoing, chronic or recurrent infectious disease, and opportunistic infection regardless of successfully treatment
研究者
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