EUCTR2014-003263-37-CZ进行中（未招募）1 期
A Phase 2A Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged =6 to <18 Years With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •1. Male or female patients =6 to <18 years of age with a diagnosis of 1. Atopic Dermatitis whose disease cannot be adequately controlled with topical medications
- •2. Minimum disease severity, as defined by Investigator’s Global Assessment (IGA)
- •a. IGA = 3 or 4 in adolescents =12 to <18 year of age
- •b. IGA = 4 in children =6 to <12 years of age
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- •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
排除标准
- •1. Recent treatment (within specific time windows before the baseline visit) with systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated) vaccines and other investigational drugs including biologics
- •2. History of any of the following infections:
- •a. Any systemic infection requiring treatment within 4 weeks before the baseline visit
- •b. Superficial skin infections within 1 week before the baseline visit
- •c. Known history of HIV infection
- •d. History of seropositivity to hepatitis B or C screening tests
- •e. History of clinical endoparasitosis (ie, helminthic infection) within 12 months before the baseline visit, or high risk of helminthic infection, unless subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled out the possibility of parasite infection/infestation
- •3. History of malignancy within 5 years before the baseline visit
- •4. Persistent (confirmed by repeated tests =2 weeks apart) elevated transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) more than 3 times the upper limit of normal (ULN) during the screening period
- •5. Presence of any severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study
- •6. Presence of skin comorbidities that may interfere with study assessments
- •7. Females patients who are pregnant or breastfeeding
- •8. Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception
研究者
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