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
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration
研究概览
简要总结
The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).
The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Minimum disease severity, as defined by Investigator's Global Assessment (IGA)
- •IGA = 3 or 4 in adolescents ≥12 to <18 year of age
- •IGA = 4 in children ≥6 to <12 years of age
排除标准
- •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
- •History of any of the following infections:
- •Any systemic infection requiring treatment within 4 weeks before the baseline visit
- •Superficial skin infections within 1 week before the baseline visit
- •Known history of HIV infection
- •History of seropositivity to hepatitis B or C screening tests
- •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
- •History of malignancy within 5 years before the baseline visit
- •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
- •Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
- •Presence of skin comorbidities that may interfere with study assessments
- •Females patients who are pregnant or breastfeeding
- •Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception
研究组 & 干预措施
Cohort 1
Cohort 1 will receive dupilumab dosing regimen 1
干预措施: Dupilumab (Drug)
Cohort 2
Cohort 2 will receive dupilumab dosing regimen 2
干预措施: Dupilumab (Drug)
结局指标
主要结局
Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration
时间窗: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration
时间窗: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose
时间窗: Pre-dose on Day 71 and Day 85
Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.
次要结局
- Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12(Baseline to Week 12 (one week after last dose))
- Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12(Baseline to Week 12 (one week after last dose))
- Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12(Baseline to Week 12 (one week after last dose))
- Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12(Week 12)
- Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12(Baseline to Week 12)