An Open-Label, Single-Arm Study to Assess Growth and Bone Mineral Density in Children ≥6 to <12 Years of Age With Severe Atopic Dermatitis Treated With Dupilumab
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 85
- 主要终点
- Improvement of ≥5 percentile in height-for-age percentile on the Centers for Disease Control and Prevention (CDC) growth chart
研究概览
简要总结
This study is researching an approved drug called dupilumab (called "study drug"). Dupilumab is approved in the United States for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (also commonly known as eczema).
The aim of the study is to see if dupilumab treatment of children with severe atopic dermatitis, which cannot be adequately controlled with topical atopic dermatitis medication, improves growth and bone strength.
The study is looking at other research questions, including:
• What side effects may happen from taking dupilumab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with body weight ≥15 kg and <60 kg at screening visit 1
- •Diagnosis of AD according to American Academy of Dermatology consensus criteria at time of screening visit
- •Investigator Global Assessment (IGA) score = 4 at screening and baseline visits
- •≥15% Body Surface Area (BSA) of AD involvement at the screening and baseline visits
- •Worst Itch Scale score ≥4 at screening visit (for prior 24 hours) and baseline visit (weekly average over prior 7 days)
- •Shorter stature defined for the study as ≤30th height-for-age percentile at screening, as defined in the protocol
- •AD not adequately controlled with topical corticosteroid prescription therapies or when those therapies are not advisable, as defined in the protocol
排除标准
- •Females who have passed menarche at screening
- •Concomitant skin diseases that may confound AD assessments in the opinion of the investigator
- •Has a known medical issue which may contribute to shorter stature (eg, growth hormone deficiency, Celiac disease)
- •Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
- •Has a known allergy or hypersensitivity to components of the study intervention
- •Prior use of dupilumab or other biologic treatment for AD, as defined in the protocol
- •Other advanced systemic treatment for AD within 4 weeks or non-steroidal topical treatments within 2 weeks before the baseline visit
- •NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
研究组 & 干预措施
dupilumab
干预措施: dupilumab (Drug)
结局指标
主要结局
Improvement of ≥5 percentile in height-for-age percentile on the Centers for Disease Control and Prevention (CDC) growth chart
时间窗: Baseline to Week 52
The Centers for Disease Control and Prevention (CDC) growth charts use percentile scales as a measurement system. The percentile scale is a ranking system that compares a child's growth measurements (e.g., height, weight, Body Mass Index \[BMI\]) to a reference population of the same age and sex.
次要结局
- Change from baseline in Lumbar Spine (LS) Bone Mineral Density (BMD) adjusted Z-score measured by Dual-Energy X-Ray Absorptiometry (DEXA)(Baseline to Week 52)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Through Week 54)
- Occurrence of Serious Adverse Events (SAEs)(Through Week 54)