CTRI/2025/11/097238尚未招募3 期
A 16-Week, Multicenter, Interventional, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Investigate Efficacy and Safety of Abrocitinib in Children 6 To Less Than 12 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 Inc.
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- 1. Response based on achieving Validated Investigators Global Assessment score of clear or almost clear and a reduction from baseline of greater than equal to 2 points at Week 12
研究概览
简要总结
This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to less than 12 years of age who have moderate-to-severe eczema. Research study participants who meet the study criteria will be assigned by chance (like the flip of a coin) to receive either abrocitinib test medicine or placebo (pretend medicine that looks just like the test medicine) for 16 weeks. The study will last for about 24 weeks in total.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria Children aged 6 to less than 12 years at the time of informed consent or assent.
- •No contraception methods are required for male participants. Disease Characteristics- Participants who meet all of the following AD 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 and
- •A diagnosis of moderate-to-severe AD at the baseline visit.
- •must fulfill all of the following criteria- BSA greater than equal to 10 percent, vIGA greater than equal to 3, EASI greater than equal to 16, and WI-NRS greater than equal to 4 and
- •Documented history within 6 months of the screening visit of inadequate response to treatment with topical medical therapy for AD eg, TCS and TCI, for at least 4 weeks and are candidates for systemic therapy.
排除标准
- •Participants are excluded from the study if any of the following criteria apply- Medical Conditions-
- •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 investigators judgment, make the participant inappropriate for the study.
- •If the participant has SDQ total score greater than equal to 17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study.
- •A copy or summary of the evaluation should be placed in the site source documents.
- •Have any of the following medical conditions- i) Infections- Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (Baseline) or have superficial skin infections 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.
- •ii) Skin Conditions- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.
- •iii) Other Conditions- Documented history of skeletal dysplasia.
- •Documented history of retinal detachment.
- •History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.
- •Prior history of leukemia, lymphoma, sarcoma or any other malignancy.
- •Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
- •Any other medical conditions that in the investigators judgment make the participant inappropriate for the study.
- •iv) Prior or Concomitant Therapy- Prior treatment with a systemic JAK inhibitor for AD.
- •v) Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes, strong inducers of CYP2C9 enzymes, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.
- •vi) Prior or Concurrent Clinical Study Experience: Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.
结局指标
主要结局
1. Response based on achieving Validated Investigators Global Assessment score of clear or almost clear and a reduction from baseline of greater than equal to 2 points at Week 12
时间窗: 1. At Week 12 | 2. At week 12
2. Response based on achieving greater than 75 percent improvement from baseline in the Eczema Area and Severity Index at Week 12
时间窗: 1. At Week 12 | 2. At week 12
次要结局
- Change from Baseline in the Worst Itch Numerical Rating Scale at Week 2(At week 2)
- Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12(At week 12)
- Response based on achieving WI-NRS less than 2 at Week 12(At week 12)
研究者
研究点 (4)
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