2025-523347-35-00招募中4 期
A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) at Week 8
研究概览
简要总结
To assess the efficacy and safety of upadacitinib compared with dupilumab as per its label, in adult subjects with inadequate response to dupilumab.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant meets all the following disease activity criteria at Baseline Visit:
- •Eczema Area and Severity Index (EASI) score >= 12;
- •Validated Investigator´s Global Assessment for AD (vIGA-AD) score >= 3;
- •Body surface area (BSA) involvement of >= 10% in a majority of subjects (>= 50% of the overall study population)
- •Baseline weekly average of daily Worst Pruritus-Numerical Rating Scale (WP-NRS) >=
- •Note: The Baseline weekly average of daily WP-NRS will be calculated from the 7 consecutive days immediately preceding the Baseline Visit. A minimum of 4 daily scores out of the 7 days is needed.
- •Inadequate response to dupilumab treatment after at least 4 months of current use.
- •Particpant has applied a topical emollient (an additive-free, bland emollient moisturizer) twice daily for at least 7 days before the Baseline Visit and for the duration of the study. Note: Subject may use prescription moisturizers or moisturizers containing ceramide, urea, filaggrin degradation products or hyaluronic acid if such moisturizers were initiated before the Screening visit.
- •Chronic AD with onset of symptoms at least 3 years prior to Baseline and subject meets Hanifin and Rajka criteria.
排除标准
- •Meeting any of the following conditions at Baseline:
- •Participants with current or past history of infection including, Evidence of Hepatitis B virus (HBV) or Hepatitis C virus (HCV)
- •At Baseline any of the following medical diseases or disorders:
- •Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aorto-coronary bypass surgery or venous thromboembolism;
- •Any unstable clinical condition which, in the opinion of the investigator would put the subject at risk by participating in the protocol;
- •Diagnosed active parasitic infection, suspected or high risk of parasitic infection unless clinical (and if necessary) laboratory assessment have ruled out active infection before randomization;
- •History of an organ transplant which requires continued immunosuppression;
- •History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class;
- •History of GI perforation (other than due to appendicitis or mechanical injury), diverticulitis, or significantly increased risk for GI perforation per investigator judgment;
- •Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery including sleeve gastrectomy; subjects with a history of gastric banding/ segmentation are not excluded;
- •History of malignancy except for successfully treated or localized carcinoma in situ of the cervix
- •Other active skin diseases or skin infections (bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline Visit or would interfere with assessment of AD lesions;
- •Two or more past episodes of herpes zoster, or one or more episodes of disseminated herpes zoster;
- •One or more past episodes of disseminated herpes simplex (including eczema herpeticum);
- •HIV infection defined as confirmed positive anti- HIV Ab test;
- •Active TB or meet TB exclusionary parameters (specific requirements for TB testing are provided in the operations manual);
- •Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to the Baseline Visit;
- •Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study;
- •COVID-19 infection: In subjects who tested positive for COVID-19, at least 5 days must have passed between a COVID-19 positive test result and the Baseline visit of asymptomatic subjects. Subjects with mild/moderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Subjects may be rescreened if deemed appropriate by the investigator based upon the subject's health status.
结局指标
主要结局
Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) at Week 8
Participants who achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) at Week 8
次要结局
- Percentage of participants who achieve a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 8
- Participants who simultaneous achieve at least a 90% reduction in Eczema Area and Severity Index from Baseline (EASI 90) and Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) at Week 8
- Percentage of participants achieving worst pruritus numerical rating scale (WP-NRS) 0/1 at Week 4
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (5)
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