JPRN-jRCT2080223467未知2 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
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 18age old 至 <= 70age old（—）
- 性别
- All
入选标准
- •Diagnosis of plaque psoriasis for 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.
排除标准
- •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 ixekizumab within 6 months of first administration of study medication
- •Has received anti-Tumor Necrosis Factor (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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