NCT05526521已完成3 期
A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 15
- 试验地点
- 15
- 主要终点
- Serum Concentration of Dupilumab at Weeks 12 and 24
研究概览
简要总结
This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.
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
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be ≥ 2 years to <12 years of age, at the time of signing the informed consent.
- •Participants who had history of a diagnosis of CSU prior to screening (Visit 1) or symptoms consistent with a diagnosis of CSU for at least 3 months in the Investigator's opinion.
- •Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for >6 weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.
- •Body weight within ≥5 kg to <60 kg.
- •Participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures.
排除标准
- •Participants were excluded from the study if any of the following criteria apply:
- •Underlying etiology for chronic urticarias other than CSU.
- •Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.
- •Participants with a diagnosis of chronic inducible cold urticaria.
- •Participants with active AD.
- •Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
- •Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated.
- •Diagnosed with, suspected of, or at high risk of endoparasitic infection.
- •Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.
- •Known or suspected immunodeficiency.
- •Active malignancy or history of malignancy within 5 years before the baseline visit.
- •History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient.
- •Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Dupilumab
Experimental
Administered subcutaneously (SC) every 4 weeks (Q4W) or every 2 weeks (Q2W) with or without an initial loading dose based on weight and age
干预措施: Dupilumab (Drug)
结局指标
主要结局
Serum Concentration of Dupilumab at Weeks 12 and 24
时间窗: Weeks 12 and 24
Blood samples were collected at specified timepoints to obtain dupilumab concentration.
次要结局
- Number of Participants With Anti-drug Antibodies (ADAs) to Dupilumab(From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(From the first dose of study intervention (Day 1) up to end of follow-up, maximum up to 36 weeks)
- Change From Baseline in Children's Dermatology Life Quality Index (C-DLQI) in Participants Aged 4 Years to <12 Years at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Infant's Dermatitis Quality of Life Index (IDQOL) in Participants Aged 2 Years to <4 Years at Week 24(Baseline (Day 1) and Week 24)
- Change From Baseline in Modified Urticaria Activity Score Over 7 Days (mUAS7) at Week 24(Baseline (Day -7 to Day 1) and Week 24)
- Change From Baseline in Itch Severity Score Over 7 Days (ISS7) at Week 24(Baseline (Day -7 to Day 1) and Week 24)
- Change From Baseline in Hive Severity Score Over 7 Days (HSS7) at Week 24(Baseline (Day -7 to Day 1) and Week 24)
研究者
研究点 (15)
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