EUCTR2018-001271-20-DE进行中（未招募）1 期
A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 WITH A PARTIALLY BLINDED EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO
Pfizer Inc 235 East 42nd Street, New York, NY10017 US0 个研究点目标入组 660 人开始时间: 2019年4月16日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 660
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 or female subjects between 18-65 years of age, inclusive, at time of informed consent.
- •Must have moderate to severe active non-segmental vitiligo.
- •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 660
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •History of human immunodeficiency virus (HIV) or positive HIV serology at screening.
- •Infected with hepatitis B or hepatitis C viruses.
- •Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB).
- •Have galactosemia (galactose-1-phosphate-uridylyltransferase or UDP-galactose-4-epimerase or galactokinase deficiency; Fanconi Bickel syndrome), a congenital lactase deficiency or glucose-galactose malabsorption.
- •Glycosylated hemoglobin A1c (HbA1c) >10%; Subjects whose diabetes mellitus is poorly controlled should be excluded;
研究者
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