A randomized, double-blind, placebo-controlled, repeat-dose study of the efficacy, safety, tolerability, and pharmacodynamics of subcutaneously-administered REGN668 in adult patients with extrinsic moderate-to-severe atopic dermatitis

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 100 人开始时间: 2011年12月15日最近更新: 2013年10月14日

研究概览

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•1. Male or female, 18 years or older
•2. Chronic Atopic dermatitis for at least 3 years
•3. History of inadequate rsponse to a stable (> / = 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for Atopic dermatitis within 3 months before the screening visit
•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 96
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•1. Prior treatment with REGN668
•2. Presence of certnain laboratory abnormalities at the screening visit
•3. Treatment with an investigational drug within 8 weeks
•4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
•5. Certain treatments and medical procedures, underaken within a particular timeframe prior to the baseline visit, preclude eligibility for participation in the study
•6. Known history of human immunodeficiency virus (HIV) infection
•7. History of malignancy within 5 years before the baseline visit, with certain exceptions
•8. Planned surgical procedure dirung the length of the patient's participation in this study
•9. History of clinical parasite infection
•10. Any medical or psychiatric condition which, in the opinion of the investigator or the sponsor’s medical monitor, would place the patient at risk, interfere with participation in the study, or interfere with the interpretation of study results
•11. Pregnant or breast-feeding women

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