A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study investigating the efficacy, safety, pharmacokinetic and biomarker profiles of Dupilumab (REGN668) administered to adult patients with moderate-to-severe Atopic dermatitis

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 240 人开始时间: 2013年5月10日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•1. Adult patients with moderate to severe atopic dermatitis whose disease cannot be adequately controlled with topical medications
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1. Prior treatment with REGN668
•2. Recent treatment (within specific time windows before the baseline visit) with systemic corticosteroids, immunosuppressive agents, topical corticosteroids and calcineurin inhibitors, live (attenuated) vaccine, other investigational drugs
•3. History of human immunodeficiency virus (HIV) infection
•4. HIV or viral hepatitis seropositivity at screening
•5. Known or suspected immunosuppresion
•6. Recent infections requiring antiinfectious treatment
•7. Recent history or high risk of clinical endoparasitoses
•8. High risk populations (low life expectancy, severe concomitant diseases, etc.)
•9. Pregnant or breast-feeding women
•10. Female patients of reproductive potential and sexually active who are unwilling to use adequate contraception

发起方