An open-label extension study to assess the long-term safety and efficacy of dupilumab in patients =6 months to <18 years of age with atopic dermatitis

Regeneron Pharmaceuticals, Inc.0 个研究点目标入组 812 人开始时间: 2015年9月15日最近更新: 2020年6月22日

研究概览

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•1. Male or female, =6 months to <18 years of age at the time of screening.
•2. Participated in a prior dupilumab study in pediatric patients with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 812
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Patients who, during their participation in a prior dupilumab study in pediatric patients with AD, developed a serious adverse event (SAE) deemed related to study drug, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient.
•2. Patients, who during their participation in a prior dupilumab study in pediatric patients with AD, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient.
•3. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit.
•4. History of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit.
•5. Known or suspected immunodeficiency.
•6. Recent infections requiring anti-infectious 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. Women of childbearing potential who are unwilling to practice highly effective contraception
•11. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit

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