A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With DBV712 250 mcg in 1-through 3-year-old Children With Peanut Allergy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 480
- 试验地点
- 165
- 主要终点
- DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
研究概览
简要总结
The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.
详细描述
This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE).
The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.
For participation eligibility, please refer to eligibility criteria section.
Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 through 3 years at Visit 1 (screening).
- •Physician-diagnosed peanut allergy and following a strict peanut-free diet
- •Peanut-specific IgE > 0.7 kUA/L.
- •A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
- •An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
排除标准
- •Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
- •Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
- •Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
- •History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
- •Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit
- •Uncontrolled persistent asthma.
研究组 & 干预措施
DBPC Treatment Period: DBV712 250 mcg
Participants will apply DBV712 250 mcg, epicutaneous system (or patch), daily for a period of 6 months.
干预措施: DBV712 250 mcg (Combination Product)
Optional Open-Label Extension-Period: DBV712 250 mcg
The 6-month DBPC period will be followed by an optional open-label extension (OLE) period during which eligible participants will receive DBV712 250 mcg for a duration of 18 months (representing 24 months of active treatment for those participants initially randomized to DBV712 250 mcg and 18 months of active treatment for those participants that were initially randomized to placebo).
干预措施: DBV712 250 mcg (Combination Product)
DBPC Treatment Period: Placebo
Participants will apply DBV712 matching placebo epicutaneous system (or patch), daily for a period of 6 months.
干预措施: Placebo (Combination Product)
结局指标
主要结局
DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
时间窗: Through DBPC Treatment Period, 6 months
次要结局
未报告次要终点