CTRI/2025/12/099009尚未招募3 期
A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older 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
- 500
- 试验地点
- 4
- 主要终点
- To evaluate long-term safety of abrocitinib in children less than equal to 2 years of age with moderate-to-severe disease
研究概览
简要总结
This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria for the Extension Cohort:
- •Participants who have completed the treatment phase of the qualifying parent study.
- •age 2 to less than 12 years old.
- •No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception during the study intervention period and for at least 28 days after the last dose of study intervention. Inclusion Criteria for the De Novo Cohort:.
- •Age: Children aged 6 to less than 12 years at the time of informed consent/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 6 months 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 10percent, 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.
- •Other Inclusion Criteria: Body weight greater than equal to 15 kg.
排除标准
- •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 investigator s 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.
- •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.
- •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 investigator s judgment make the participant inappropriate for the study.
- •Prior or Concomitant Therapy:
- •Prior treatment with a systemic JAK inhibitor for AD.
- •Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.
- •Prior or Concurrent Clinical Study Experience:
- •Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day
- •Diagnostic Assessments:
- •Hepatic and or renal and or hematological abnormalities defined as: AST greater 2 x ULN Hemoglobin less than 10 g per dL ALT greater 2 x ULN ANC less than 1000 per mm3 Total bilirubin greater than equal to 1.5 x ULN ALC less than 500 per mm3 eGFR less than 60 mL per min per 1.73 m2 Platelets less than 150,000 per mm3 Other Exclusion Criteria: Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
结局指标
主要结局
To evaluate long-term safety of abrocitinib in children less than equal to 2 years of age with moderate-to-severe disease
时间窗: 0 to 24 months
次要结局
- Number of Participants With Clinically Significant Laboratory Abnormalities(0-24 months)
- Response based on achieving Validated Investigators Global Assessment score of clear 0 or almost clear 1 on a 5-point scale and a 2 point reduction from baseline at all scheduled time points(Baseline, 24 months)
- Percentage of Response based on achieving a greater than equal to 4 point improvement from baseline in the Worst Itch Numerical Rating Scale at all scheduled time points in participants aged greater than equal to 2 to less than 6 years(0-24 months)
- Percentage of Response based on achieving a greater than equal to 4 point improvement from baseline in the WSI-NRS at all scheduled time points in participants aged greater than equal to 6 to 12 years(0-24 months)
- Percentage of Responders based on achieving Eczema Area and Severity Index EASI-50, EASI-90 and EASI-100 at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib(0-24 months)
- Percent Change from Baseline in EASI total score at all scheduled time points.(0-24 months)
- Percentage of Participants with Flares(0-24 months)
- CFB in the percentage Body Surface Area affected at all scheduled time points(0-24 months)
- CFB in Children Dermatology Life Quality Index at all scheduled time points.(0-24 months)
- CFB in in Infants Dermatitis Quality of Life Index at all scheduled time points(0-24 months)
- CFB in Patient-Oriented Eczema Measure at all scheduled time points(0-24 months)
- CFB in Dermatitis Family Impact at all scheduled time points(0-24 months)
- CFB in Patient Global Impression of Severity at all scheduled time points(0-24 months)
- CFB in Observer Reported Global Impression of Severity at all scheduled time points(0-24 months)
- CFB in the the EuroQol- 5 Dimension Youth(0-24 months)
- Number of topical corticosteroid and or topical calcineurin inhibitor free days(0-24 months)
- Percentage of Participants Achieving satisfactory response in Tdap or DTaP and or pneumococcal antibody titers as appropriate in participants who receive Tdap or DTaP and or pneumococcal vaccinations(0-24 months)
研究者
研究点 (4)
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