2023-504331-41-00招募中3 期
A randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy and long-term safety of dupilumab in children 2 to <6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze
Sanofi-Aventis Research & Development31 个研究点 分布在 9 个国家目标入组 69 人开始时间: 2023年12月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 69
- 试验地点
- 31
- 主要终点
- Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period.
研究概览
简要总结
• Part A: To assess the efficacy of dupilumab in reducing the annualized rate of severe asthma exacerbations at Week 52 compared to placebo • Part B: Safety and tolerability of dupilumab in children aged 2 to <6 years old with uncontrolled asthma and/or recurrent severe asthmatic during Part B
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be 2 to <6 years of age
- •Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze.
- •At least one additional major criterion from the modified asthma predictive index: a) Physician diagnosed Atopic Dermatitis, b) Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L). OR 2 minor critieria: c) Wheezing unrelated to colds, d) Peripheral blood eosinophilia ≥4%, e) Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE >0.35 kU/L.
- •Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures.
- •Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements.
- •Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires
- •Body weight at screening and randomization >5 kg and <30 kg.
- •Parents or caregivers or legal guardian capable of giving signed informed consent.
排除标准
- •Severe asthma with the need for chronic oral/systemic corticosteroid use (>1 month continuous) at the time of screening enrollment.
- •History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient.
- •History of prematurity (<34 weeks gestation).
- •Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period.
- •History of life-threatening asthma (eg, requiring intubation).
结局指标
主要结局
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period.
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period.
Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation
Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation
次要结局
- Part A: Change from baseline to Week 52 in Physician Global Assessment of the child’s asthma control (PGA-asthma control).
- Part A: Change from baseline to Week 52 in Test for Respiratory and Asthma Control in Kids (TRACK)
- Part A: Change from baseline in blood eosinophil level at Weeks 24 and 52
- Part A: Concentration of dupilumab in serum over time during the 52-week treatment period
- Part A: Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab over time
- Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52 week treatment period.
- Part A: Annualized rate of moderate asthma exacerbations during the 52-week treatment period
- Part A: Cumulative ICS dose during the 52-week treatment period
- Part A: Change from baseline in weekly average use of reliever medication during the 52-week treatment period
- Part A: Mean number of days without asthma symptoms (DWAS) using the Pediatric Asthma Caregiver Diary (PACD) during the 52-week treatment period
- Part A: Change from baseline to Week 52 in daytime symptom score using the daytime record of PACD
- Part A: Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation
- Part A: Change from baseline to Week 52 in Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Scale
- Part A: Caregiver Global Impression of Change in their child’s asthma control (CGI-change in asthma control) at Week 52
- Part A: Physician Global Assessment of Change of the child’s asthma control (PGA-change in asthma control) at Week 52
- Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child’s asthma control (CGI-asthma control)
- Part A: Change from baseline to Week 52 in Caregiver Global Impression of their child’s asthma severity (CGI-asthma severity)
- Part A: IgG response to any vaccination for tetanus, diphtheria and pertussis and antibody for influenza (HAI antibody titers) vaccine administered according to vaccination schedule during the 52-week treatment period
- Part B: Annualized rate of severe asthma exacerbations events during the 52-week Part B treatment period
- Part B Concentration of dupilumab in serum over time during the 52-week Part B treatment period
- Part B: Incidence of treatment-emergent anti-drug antibodies (ADAs) against dupilumab over time
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Research & Development
研究点 (31)
Loading locations...
相似试验
尚未招募
不适用
A randomized, double-blind, placebo-controlled, parallel study with an open label placebo extensionCTRI/2023/05/052481Vidya Herbs Pvt Ltd24
已完成
1 期
the Safety, Tolerability and PK of KX-826 in Healthy Males With Alopecia Following Topical Multiple Dose AscendingAndrogenetic AlopeciaNCT04502901Suzhou Kintor Pharmaceutical Inc,40
已完成
2 期
A randomised, double blind, placebo-controlled study of RAD001 (Everolimus) in the treatment of neurocognitive problems in tuberous sclerosisTuberous sclerosisNervous System DiseasesISRCTN09739757Cardiff University (UK)38
已完成
2 期
Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)DementiaAlzheimer's DiseaseNCT00104273Teva Branded Pharmaceutical Products R&D, Inc.376
已完成
1 期
A study of the effects of different doses of oliceridine on several brain functions and a pain test, in healthy volunteers, compared to morphineEffects of oliceridine and morphine on neurocognition and pain in healthy participantsISRCTN13308001Trevena, Inc.23