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Edyta Gebska","Chorzów","Silesian Voivodeship","41-500",{"type":54,"coordinates":372},[373,374],18.9742,50.30582,{"lat":374,"lon":373},{"facility":377,"status":47,"city":378,"state":369,"zip":379,"country":349,"countryCode":350,"cosmosGeoPoint":380,"geoPoint":384,"contacts":30},"Centrum Medyczne Angelius Provita","Katowice","40-611",{"type":54,"coordinates":381},[382,383],19.02173,50.2597,{"lat":383,"lon":382},{"facility":386,"status":47,"city":387,"state":388,"zip":389,"country":349,"countryCode":350,"cosmosGeoPoint":390,"geoPoint":394,"contacts":30},"Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. 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Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.\n\nDisease Characteristics:\n\nParticipants who meet all of the following AD criteria:\n\n* 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\n* 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\n* 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\n\nOther Inclusion Criteria:\n\nBody weight ≥15 kg\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\nAny 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.\n\nIf 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.\n\nHave any of the following medical conditions:\n\n* Infections:\n\n  * 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 1.\n  * 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 1.\n  * Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.\n  * Infection with HIV, hepatitis B, and\u002For hepatitis C\n  * Evidence of active TB or inadequately treated latent TB.\n* Skin Conditions:\n\n  \\- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.\n* Other Conditions:\n\n  * Documented history of skeletal dysplasia.\n  * Documented history of retinal detachment.\n  * History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.\n  * Prior history of leukemia, lymphoma, sarcoma or any other malignancy.\n  * Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.\n  * Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.\n\nPrior\u002FConcomitant Therapy:\n\nPrior 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.\n\nConcomitant 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.\n\nPrior\u002FConcurrent Clinical Study Experience:\n\nPrevious administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.","ALL","6 Years","11 Years",{"count":449,"type":450},150,"ESTIMATED","INTERVENTIONAL",[453],"PHASE3","This research study is being conducted to find out if the test medicine, abrocitinib, improves eczema and is safe for children 6 to \\\u003C12 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.",[456],"Eczema",[458],"Dermatitis","2026-05-05",{"date":461,"type":462},"2026-05-06","ACTUAL",{"date":464,"type":462},"2025-07-24",{"date":466,"type":450},"2027-05-02",{"name":5,"class":6},41]