Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of Participants with Successful Discontinuation of Dupilumab
研究概览
简要总结
This is a pilot investigator-blinded, randomized clinical trial to assess the feasibility of dupilumab treatment discontinuation or dose-reduction in children aged 1-17 years who have achieved sustained atopic dermatitis (AD) control on dupilumab.
详细描述
Participants will be randomly assigned to one of three groups: discontinuation of dupilumab; reduction of dupilumab dose; or continuation of standard dupilumab dose. During the active study treatment period, participants will be asked to complete 5 study visits. At these visits, a physician will conduct a skin examination to assess atopic dermatitis (AD) severity and participants will complete questionnaires about their AD symptoms and severity. During the observational period, participants will be asked to complete questionnaires about their AD symptoms and medication use every twelve weeks, for a total of 3 follow-up contacts. The purpose of this study is to evaluate the feasibility and sustainability of reducing or discontinuing dupilumab in children with well-controlled 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
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants are unblinded to the trial arm. Clinical outcomes will be assessed by a blinded investigator.
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 to <18 years old, either sex, any race or ethnicity
- •Provide signed informed consent by parent or legal guardian and informed assent if applicable
- •Has a physician confirmed diagnosis of atopic dermatitis
- •Has received dupilumab for at least 12 months for the treatment of atopic dermatitis
- •Has had well-controlled atopic dermatitis on dupilumab within last 6 months (defined as POEM<=7, EASI<=7, or IGA<=2)
- •Able to speak English
- •Able and willing to adhere to all study procedures
排除标准
- •Taking concurrent systemic medication for atopic dermatitis (e.g., methotrexate, cyclosporine, tralokinumab, abrocitinib, upadacitinib, systemic corticosteroids)
- •Using concurrent phototherapy for atopic dermatitis
- •Taking dupilumab for a clinical indication other than atopic dermatitis (such as asthma or eosinophilic esophagitis)
- •Poor control of atopic dermatitis
- •Poor control of asthma or eosinophilic esophagitis
- •Has used an investigational drug within 90 days or plan to use an investigational drug during the study period
- •Does not have health insurance or will lose health insurance during the study period
研究组 & 干预措施
Dupilumab - dose reduction
Participants whose standard dupilumab dosing for atopic dermatitis is 200 mg or 300 mg every 2 weeks will decrease drug administration to every 4 weeks, and participants whose standard dupilumab dosing is 200 mg or 300 mg every 4 weeks will decrease administration to every 8 weeks.
干预措施: Dupilumab - Dose Reduction (Drug)
Dupilumab - standard dosing
Participants will continue to receive standard maintenance dupilumab dosing for atopic dermatitis according to FDA labeling, as indicated below.
Infants ≥6 months and Children <6 years:
5 to <15 kg: 200 mg every 4 weeks. 15 to <30 kg: 300 mg every 4 weeks
Children ≥6 years and Adolescents ≤17 years:
15 to <30 kg: 300 mg every 4 weeks 30 to <60 kg: 200 mg every other week
≥60 kg: 300 mg every other week
干预措施: Dupilumab - Standard Dose (Drug)
Dupilumab - discontinuation
Participants will discontinue their dupilumab treatment for atopic dermatitis.
干预措施: Dupilumab - Discontinuation (Drug)
结局指标
主要结局
Percentage of Participants with Successful Discontinuation of Dupilumab
时间窗: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
Successful discontinuation is defined as maintaining discontinuation of dupilumab after initial discontinuation on week 0. Patients who require resumption of dupilumab or beginning other systemic treatments for their AD will be regarded as treatment failure.
Percentage of Participants with Successful Dose Reduction of Dupilumab
时间窗: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
Successful de-escalation is defined as maintaining a reduced dose (i.e., less frequent administration) of dupilumab after initial de-escalation on week 0. Patients who require re-escalating the dose of dupilumab to standard dosing or adding other systemic treatments for their AD will be regarded as treatment failure.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Investigator's Global Assessment (IGA) Scores(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Patient Oriented Eczema Measure (POEM) Scores(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Eczema Area and Severity Index (EASI) Scores(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Children's Dermatology Life Quality Index (CDLQI) score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Change in Family Dermatology Life Quality Index (FDLQI) score(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Changes in Utilization of Topical Medications for Atopic Dermatitis(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))
- Adverse Events After Dupilumab Dose-reduction or Discontinuation(From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase))