NCT03345914已完成3 期
A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16
研究概览
简要总结
The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age with severe atopic dermatitis (AD).
The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to <12 years of age with severe AD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
- •Chronic AD diagnosed at least 1 year prior to the screening visit
- •IGA = 4 at screening and baseline visits
- •EASI ≥21 at the screening and baseline visits
- •BSA ≥15% at screening and baseline visits
- •Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
- •At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit
排除标准
- •Participation in a prior dupilumab clinical study
- •Treatment with a systemic investigational drug before the baseline visit
- •Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
- •Treatment with crisabarole within 2 weeks prior to the baseline visit
- •History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician
- •Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
- •Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- •Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- •Phototherapy for AD
- •Treatment with biologics, as follows:
- •Any cell-depleting agents including but not limited to rituximab:
- •within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
- •Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
- •Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
- •Body weight <15 kg at baseline
- •Note: Other Inclusion/ Exclusion criteria apply
研究组 & 干预措施
Group 1
Experimental
Participants will receive dupilumab, dosing regimen 1
干预措施: Dupilumab (Drug)
Group 2
Experimental
Participants will receive dupilumab, dosing regimen 2
干预措施: Dupilumab (Drug)
Group 3
Experimental
Participants will receive matching placebo
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Investigator's Global Assessment (IGA) 0 or 1 at Week 16
时间窗: Week 16
The IGA was an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe). The full analysis set (FAS) included all randomized participants. Efficacy analyses were based on the treatment allocated at randomization (as randomized). Values after first rescue treatment used were set to missing. Participants with missing score at Week 16 were considered as a non-responder.
次要结局
- Percent Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16(Baseline (Day 1), Week 16)
- Time to Achieve ≥ 4 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period(Baseline (Day 1) up to Week 16)
- Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 16(Baseline (Day 1), Week 16)
- Change From Baseline in Weekly Average of Daily Worst Itch Score at Week 16(Baseline (Day 1), Week 16)
- Percentage of Participants With Eczema Area and Severity Index -75 (EASI-75) (≥ 75 Percent (%) Improvement From Baseline) at Week 16(Week 16)
- Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥3 Points at Week 16(Week 16)
- Change From Baseline in Patient Oriented Eczema Measure (POEM) at Week 16(Baseline (Day 1), Week 16)
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 16(Baseline (Day 1), Week 16)
- Time to Achieve ≥ 3 Point Reduction of Weekly Average of Daily Worst Itch Score From Baseline During the 16-week Treatment Period(Baseline (Day 1) up to Week 16)
- Percentage of Participants With Improvement (Reduction From Baseline) of Weekly Average of Daily Worst Itch Score ≥4 Points at Week 16(Week 16)
- Percentage of Participants Achieving Eczema Area and Severity Index - 50 (EASI-50) (≥ 50% Improvement From Baseline) at Week 16(Week 16)
- Percentage of Participants Achieving Eczema Area and Severity Index - 90 (EASI - 90) (≥ 90% Improvement From Baseline) at Week 16(Week 16)
- Proportion of Topical Corticosteroid (TCS) Medication-free Days From Baseline to Week 16(Baseline (Day 1), Week 16)
- Change From Baseline in Percent Body Surface Area (BSA) Affected by Atopic Dermatitis (AD) at Week 16(Baseline (Day 1), Week 16)
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16(Baseline (Day 1), Week 16)
- Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Anxiety Short Form Scale Total Score at Week 16(Baseline (Day 1), Week 16)
- Percentage of Participants Having at Least One Skin Infection Treatment Emergent Adverse Event (TEAE) (Excluding Herpetic Infections) Through Week 16(Baseline through Week 16)
- Percentage of Participants Having at Least One Serious Treatment Emergent Adverse Event (TEAE) Through Week 16(Baseline (Day 1) through Week 16)
- Change From Baseline in Dermatitis Family Index (DFI) at Week 16(Baseline (Day 1) , Week 16)
- Change From Baseline in Patient Reported Outcomes Measurements Information Systems (PROMIS) Pediatric Depressive Symptoms Short Form Scale Score at Week 16(Baseline (Day 1), Week 16)
- Mean Weekly Dose of Topical Corticosteroid (TCS) in Grams for Low or Medium Potency TCS From Baseline to Week 16(Baseline (Day 1), Week 16)
研究者
研究点 (1)
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