EUCTR2014-003263-37-PL进行中（未招募）不适用
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
- 不适用
- 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
- •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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