EUCTR2016-002481-31-LV进行中（未招募）1 期
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986165 in Subjects with Moderate to Severe Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 516
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, ages 18 to 70 years
- •- Diagnosis of plaque psoriasis for less or equal to 6 months
- •- Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test, must not be pregnant, lactating, breastfeeding or planning pregnancy.
- •- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment plus 5 half-lives of the study drug plus 90 days.
- •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 439
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •- Diagnosis of non-plaque psoriasis
- •- History or evidence of active infection and/or febrile illness
- •- Any significant acute or chronic medical illness
- •- Blood transfusion within 4 weeks of study drug administration
- •- Inability to tolerate oral medication
- •- Positive hepatitis-B (HBV) surface antigen
- •- Positive hepatitis-C (HCV) antibody
- •- Any history or risk for tuberculosis (TB)
- •- Any major illness/condition or evidence of an unstable clinical condition
- •- Chest X-ray findings suspicious of infection at screening
- •- Has received ustekinumab, secukinumab or ixikizumab within 6 months of first administration of study medication
- •- Has received anti-TNF inhibitor(s) within 2 months of first administration of study medication
- •- Has received Rituximab within 6 months of first administration of study medication
- •- Topical medications/treatments for psoriasis within 2 weeks of the first administration of any study medication
- •- any systemic medications/treatments for psoriasis within 4 weeks of the first administration of any study medication
研究者
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