A 16-WEEK, MULTICENTER, INTERVENTIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF ABROCITINIB IN CHILDREN 2 TO LESS THAN 6 YEARS OF AGE WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 90
- 主要终点
- Response based on achieving validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
研究概览
简要总结
This clinical study is designed to test how well a medicine called abrocitinib works and how safe it is for young children (ages 2 to under 6) who have moderate-to-severe eczema (also known as atopic dermatitis).Eczema is a skin condition that can cause the skin to be dry, itchy, have scaly patches, blisters and skin infections.
How the study works:
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Children will be randomly placed into two groups:
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2 out of 3 will get the real medicine (abrocitinib).
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1 out of 3 will get a placebo (a look-alike liquid with no active medicine).
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Neither the families nor the doctors will know which group each child is in (this is called double-blind).
This study is seeking for children:
- between 2 and under 6 years old.
- Who have had eczema for at least 1 year.
- Who have moderate-to-severe eczema at the start of the study, based on skin area affected and symptom scores.
The medicine is given once a day as a liquid. The amount given depends on the child's body weight. If the child's eczema doesn't improve enough between weeks 4 and 8, the dose might be increased (still without anyone knowing which group they're in), unless the child can't tolerate it.
All children will also use standard medicated creams during the study. The study will be up to 24 weeks long and there will be a screening period (up to 28 days) to make sure each child qualifies for the study.
详细描述
This is a 16-week, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of abrocitinib compared to placebo in participants aged 2 to <6 years with moderate-to-severe AD. Participants will be screened within 28 days prior to the first dose of study intervention to confirm study eligibility. Participants who continue to meet eligibility criteria at baseline will be randomized 2:1 to abrocitinib oral suspension (at 100 mg adult equivalent dose level [AED] once daily [QD]) or matching placebo. Participants will be stratified by their baseline vIGA (score of 3 or 4). At the starting dose level of 100 mg QD AED, the dose volume (in mL of oral suspension) will depend on the participant's body weight.
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2 to <6 years at the time of informed consent /assent.
- •Disease Characteristics:
- •All participants must meet all of the following criteria:
- •A documented diagnosis of chronic AD for at least 1 year prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria;
- •A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16 and WSI-NRS ≥4).
- •For countries outside the US:
- •Eligible participants must have:
- •a documented history within 6 months before the screening visit of inadequate response to treatment with topical medicated therapy for AD (eg, TCS and TCI) for at least 4 weeks, or;
- •required at least 1 systemic therapy for control of their disease.
- •For US only:
- •Eligible participants are those whose disease is not adequately controlled with at least 1 systemic therapy or when the use of systemic therapies is inadvisable.
- •Prior systemic therapies may include biologics such as dupilumab, oral agents such as corticosteroids, cyclosporine, methotrexate Note that an inadequate response to topical treatments alone is not sufficient for eligibility in the US.
- •Other Inclusion Criteria:
- •Body weight ≥10 kg.
排除标准
- •Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline), or have non-typical pediatric superficial skin infections (excluding common self-limiting viral conditions such as verruca vulgaris and molluscum contagiosum) within 1 week of Day
- •History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day
- •Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.
- •Infection with HIV, hepatitis B, and/or hepatitis C.
- •Evidence of active TB or inadequately treated latent TB.
- •Prior treatment with a systemic JAK inhibitor for AD.
- •Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.
- •Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, sensitive P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates with narrow therapeutic index are not allowed in the study.
研究组 & 干预措施
Matching Placebo
Participants will receive liquid oral suspension of matching placebo.
干预措施: Placebo (Drug)
Abrocitinib
Participants will receive liquid oral suspension of Abrocitinib.
干预措施: Abrocitinib (Drug)
结局指标
主要结局
Response based on achieving validated Investigator's Global Assessment (vIGA) score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at Week 12
时间窗: Baseline, week 12
The difference in percentage of responders based on vIGA at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo.
Response based on achieving ≥75% improvement from baseline in Eczema and Severity Index (EASI) at Week 12
时间窗: Week 12
The difference in percentage of responders based on EASI-75 at Week 12 in participants with moderate-to-severe AD treated with abrocitinib versus placebo
次要结局
- Change from baseline (CFB) in the Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) at Week 2(Baseline, Week 2)
- Response based on achieving at least a 4-point improvement from baseline in the WSI-NRS at Week 12(Week 12)
- Response based on achieving WSI-NRS <2 at Week 12(Week 12)