2023-509121-51-00招募中3 期
B7451023 - 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
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 54
- 试验地点
- 13
- 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
To evaluate efficacy of abrocitinib compared with placebo when co-administered with background topical medications in children 6 to <12 years of age with moderate-to-severe AD
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to <12 years at the time of informed consent/assent.
- •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[19]; and 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 WI-NRS ≥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
- •Body weight ≥15 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. If the participant has SDQ total score ≥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: 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 (Section 8.3.6 and Appendix 10). - 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 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, P-gp substrates with narrow therapeutic index and sensitive CYP2C19 substrates is not allowed in the study.
- •Previous administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, of Day
- •Hepatic and/or renal and/or hematological abnormalities defined as: AST >2 x ULN Hemoglobin <10 g/dL ALT >2 x ULN ANC <1000/mm3 Total bilirubin ≥1.5 x ULN ALC <500/mm3 eGFR 60 mL/min/1.73 m2 Platelets <150,000 /mm3
- •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
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
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
Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI-75) at Week 12
Response based on achieving ≥75% improvement from baseline in the Eczema Area and Severity Index (EASI) total score (EASI-75) at Week 12
次要结局
- Percent CFB in EASI total score at all scheduled time points
- Time from baseline to achieving at least a 4- point improvement in the WI-NRS scale
- Change from baseline (CFB) in the Worst Itch Numerical Rating Scale (WI-NRS) at Week 2
- Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at Week 12
- Response based on achieving WI-NRS < 2 at Week 12
- Response based on achieving vIGA score of clear (0) or almost clear (1) (on a 5-point scale) and a reduction from baseline of ≥2 points at all scheduled time points (except for the time point analyzed for the primary endpoints)
- Response based on achieving ≥50%, ≥75%, ≥90%, 100% improvement from baseline in the EASI total score (EASI-50, EASI-75, EASI-90, EASI-100) at all scheduled time points (except for the time point analyzed for the primary endpoints)
- Response based on achieving at least a 4-point improvement from baseline in the WI-NRS at all scheduled time points (except for the time point analyzed for the key secondary endpoint)
- Response based on achieving WI-NRS <2 at all scheduled time points (except for the time point analyzed for the key secondary endpoint)
- Response based on achieving WI-NRS <2 and EASI-90 at all scheduled time points
- CFB in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points (except for the time point analyzed for the key secondary endpoint)
- CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points
- CFB in Children’s Dermatology Life Quality Index (CDLQI) at all scheduled time points
- CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points
- CFB in Dermatitis Family Impact (DFI) score at all scheduled time points
- Topical corticosteroids- and topical calcineurin inhibitor-free days
- CFB in the length of time scratching at night at all scheduled time points
- CFB in the sleep efficiency at all scheduled time points
- The incidence of treatment-emergent adverse events, serious adverse events and adverse events leading to discontinuation
- The incidence of clinically significant laboratory abnormalities
- Immune response to diphtheria, tetanus, and acellular pertussis vaccine (DTaP/Tdap) and/or pneumococcal vaccines in participants who received DTaP/Tdap and/or pneumococcal vaccination
- Acceptability and Palatability Questionnaire to rate overall formulation taste and dosing experience.
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (13)
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