[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06807281":3,"trial-entities:NCT06807281":436,"trial-summary:NCT06807281":439},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":45,"sex":98,"minimum_age":99,"maximum_age":100,"healthy_volunteers":101,"eligibility_criteria":102,"std_ages":131,"locations":133,"central_contacts":422,"overall_officials":428,"references":431,"see_also_links":432},"NCT06807281","B7451031","A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema","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","RECRUITING","2032-02-22","2026-08","2026-08-17","2025-12-02","Pfizer","INDUSTRY",true,"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.","Phase 3, open-label study to assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children ≥2 years of age with moderate-to-severe atopic dermatitis (AD). This study will enroll participants in two cohorts: an extension cohort of participants who previously completed prior abrocitinib studies, and a de novo cohort of participants (6 to \\\u003C12 years of age) who have not participated in previous abrocitinib studies. Study duration will be up to 2 years (or commercial availability, whichever occurs earlier). The study will enroll a maximum of approximately 500 participants with moderate-to-severe Atopic Dermatitis from study sites globally (extension cohort will enroll up to 320 participants; de novo cohort will enroll approximately 180 participants). All participants will receive the study intervention abrocitinib oral suspension.",[19],"Atopic Dermatitis",[21,22],"eczema","atopic dermatitis","INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},500,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"DRUG","Abrocitinib","Abrocitinib administered as liquid oral suspension.",[36,37],"De novo","Extension",[39],"PF-04965842",[41],{"measure":42,"description":43,"timeFrame":44},"Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation","The number of the treatment emergent adverse events, serious adverse events and adverse events leading to discontinuation among patients with moderate-to-severe disease treated with abrocitinib regardless of discontinuation from study treatment.","0-24 months",[46,49,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95],{"measure":47,"description":48,"timeFrame":44},"Number of Participants With Clinically Significant Laboratory Abnormalities","The number of clinically significant laboratory abnormalities among participants with moderate-to-severe disease treated with abrocitinib.",{"measure":50,"description":51,"timeFrame":52},"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 2 -point reduction from baseline at all scheduled time points","Proportion of responders based on vIGA at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib","Baseline, 24 months",{"measure":54,"description":55,"timeFrame":44},"Percentage of Response based on achieving a ≥4 point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS) at all scheduled time points in participants aged ≥2 to \u003C6 years","Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WI-NRS (in patients aged ≥2 to \\\u003C6 years) with moderate-to-severe disease treated with abrocitinib.",{"measure":57,"description":58,"timeFrame":44},"Percentage of Response based on achieving a ≥4-point improvement from baseline in the WSI-NRS at all scheduled time points in participants aged ≥6 to 12 years","Percentage of responders based on achieving an improvement ≥4 points from baseline at all scheduled time points in the WSI-NRS (in patients aged ≥6 to 12 years) with moderate-to-severe disease treated with abrocitinib.",{"measure":60,"description":61,"timeFrame":44},"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","Percentage of response based on achieving ≥50%, ≥90%, 100% improvement from parent study baseline in the EASI total score (EASI-50, EASI-90, EASI-100) at all scheduled time points.",{"measure":63,"description":64,"timeFrame":44},"Percent Change from Baseline (CFB) in EASI total score at all scheduled time points.","Mean percent CFB in EASI total score at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib",{"measure":66,"description":67,"timeFrame":44},"Percentage of Participants with Flares","Percentage of participants reporting flares in patients with moderate-to-severe disease treated with abrocitinib.",{"measure":69,"description":70,"timeFrame":44},"CFB in the percentage Body Surface Area (BSA) affected at all scheduled time points","Mean CFB in BSA affected at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.",{"measure":72,"description":73,"timeFrame":44},"CFB in Children's Dermatology Life Quality Index (CDLQI) at all scheduled time points.","Mean CFB in CDLQI at all scheduled time points in participants aged ≥4 to \\\u003C16 years with moderate-to-severe disease treated with abrocitinib.",{"measure":75,"description":76,"timeFrame":44},"CFB in in Infants' Dermatitis Quality of Life (IDQOL) Index at all scheduled time points","Mean CFB in IDQOL Index or CDQLI depending on age at all scheduled time points in participants aged \\\u003C4 years with moderate-to-severe disease treated with abrocitinib",{"measure":78,"description":79,"timeFrame":44},"CFB in Patient-Oriented Eczema Measure (POEM) at all scheduled time points","Mean CFB in POEM at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.",{"measure":81,"description":82,"timeFrame":44},"CFB in Dermatitis Family Impact (DFI) at all scheduled time points","Mean CFB in DFI at all scheduled time points in participants with moderate-to-severe disease treated with abrocitinib.",{"measure":84,"description":85,"timeFrame":44},"CFB in Patient Global Impression of Severity (PGIS) at all scheduled time points","Mean CFB in PGIS (in patients aged 6 to \\\u003C12 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib.",{"measure":87,"description":88,"timeFrame":44},"CFB in Observer Reported Global Impression of Severity (OGIS) at all scheduled time points","Mean CFB in OGIS (in patients aged 2 to \\\u003C6 years) at all scheduled time points in patients with moderate-to-severe disease treated with abrocitinib",{"measure":90,"description":91,"timeFrame":44},"CFB in the the EuroQol- 5 Dimension Youth (EQ-5D-Y)","Mean CFB in EQ-5D-Y at all scheduled time points in patients with moderate-tosevere AD treated with abrocitinib versus placebo.",{"measure":93,"description":94,"timeFrame":44},"Number of topical corticosteroid and \u002For topical calcineurin inhibitor free days","Mean number of days free from topical corticosteroids and \u002For topical calcineurin inhibitor use in patients with moderate-to-severe disease treated with abrocitinib.",{"measure":96,"description":97,"timeFrame":44},"Percentage of Participants Achieving satisfactory response in Tdap\u002FDTaP and\u002For pneumococcal antibody titers as appropriate in participants who receive Tdap\u002FDTaP and\u002For pneumococcal vaccinations","For patients that receive Tdap\u002F DTap and\u002For pneumococcal vaccinations during the study, the proportion of patients treated with abrocitinib who achieve satisfactory immunogenicity at 4 weeks after receiving the vaccinations.","ALL","2 Years","11 Years",false,{"inclusion":103,"exclusion":107,"raw_text":130},[104,105,106],"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 ≥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.",[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129],"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 1.","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.","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\u002For hepatitis C","Evidence of active TB or inadequately treated latent TB.","Skin Conditions:","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.","AST \\>2 x ULN","Hemoglobin \\\u003C10 g\u002FdL","ALT \\>2 x ULN","ANC \\\u003C1000\u002Fmm3","Total bilirubin ≥1.5 x ULN","ALC \\\u003C500\u002Fmm3","eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2","Platelets \\\u003C150,000 \u002Fmm3","Inclusion Criteria for the Extension Cohort:\n\n1\\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \\\u003C12 years old).\n\n• 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 (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention.\n\nInclusion Criteria for the De Novo Cohort:\n\nAge\n\n1. Children aged 6 to \\\u003C12 years at the time of informed consent\u002Fassent.\n\n   • No contraception methods are required for male participants.\n\n   Disease Characteristics:\n2. Participants who meet all of the following AD criteria:\n\n   * 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\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\n   Other Inclusion Criteria:\n3. Body weight ≥15 kg\n\nExclusion Criteria for the Extension Cohort:\n\nMedical Conditions:\n\n1. 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.\n\n   If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them 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\n   Prior\u002FConcomitant Therapy:\n2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.\n3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.\n\n   Diagnostic Assessments:\n4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.\n5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.\n\nExclusion Criteria for the De Novo Cohort\n\nMedical Conditions:\n\n1. 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.\n\n   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.\n2. Have 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\n   Prior\u002FConcomitant Therapy:\n3. Prior treatment with a systemic JAK inhibitor for AD.\n4. 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.\n5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.\n\n   Prior\u002FConcurrent Clinical Study Experience:\n6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.\n\n   Diagnostic Assessments:\n7. Hepatic and\u002For renal and\u002For hematological abnormalities defined as:\n\n   * AST \\>2 x ULN\n   * Hemoglobin \\\u003C10 g\u002FdL\n   * ALT \\>2 x ULN\n   * ANC \\\u003C1000\u002Fmm3\n   * Total bilirubin ≥1.5 x ULN\n   * ALC \\\u003C500\u002Fmm3\n   * eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m2\n   * Platelets \\\u003C150,000 \u002Fmm3\n\n   Other Exclusion Criteria:\n8. 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.",[132],"CHILD",[134,143,151,160,163,171,179,187,195,202,210,219,227,235,243,251,258,262,271,279,288,293,302,310,315,322,326,335,343,350,359,367,375,382,390,398,407,415],{"facility":135,"status":8,"city":136,"state":137,"zip":138,"country":139,"geoPoint":140},"Cahaba Dermatology & Skin Health Center","Birmingham","Alabama","35244","United States",{"lat":141,"lon":142},33.52066,-86.80249,{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":139,"geoPoint":148},"Arkansas Research Trials","North Little Rock","Arkansas","72117",{"lat":149,"lon":150},34.76954,-92.26709,{"facility":152,"status":153,"city":154,"state":155,"zip":156,"country":139,"geoPoint":157},"Investigational Drug Service - Rady Childrens Hospital-San Diego","NOT_YET_RECRUITING","San Diego","California","92123",{"lat":158,"lon":159},32.71571,-117.16472,{"facility":161,"status":153,"city":154,"state":155,"zip":156,"country":139,"geoPoint":162},"University of California, San Diego\u002F Rady Children's Hospital - San Diego",{"lat":158,"lon":159},{"facility":164,"status":8,"city":165,"state":166,"zip":167,"country":139,"geoPoint":168},"Solutions Through Advanced Research","Jacksonville","Florida","32256",{"lat":169,"lon":170},30.33218,-81.65565,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":139,"geoPoint":176},"Dawes Fretzin Clinical Research Group, LLC","Indianapolis","Indiana","46250",{"lat":177,"lon":178},39.76838,-86.15804,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":139,"geoPoint":184},"Saint Louis University","St Louis","Missouri","63104",{"lat":185,"lon":186},38.62727,-90.19789,{"facility":188,"status":8,"city":189,"state":190,"zip":191,"country":139,"geoPoint":192},"Medical University of South Carolina - South Carolina Translational Research Nexus Clinic","Charleston","South Carolina","29425",{"lat":193,"lon":194},32.77632,-79.93275,{"facility":196,"status":8,"city":197,"state":190,"zip":198,"country":139,"geoPoint":199},"Tribe Clinical Research, LLC","Greenville","29607",{"lat":200,"lon":201},34.85262,-82.39401,{"facility":203,"status":153,"city":204,"state":205,"zip":206,"country":139,"geoPoint":207},"Texas Dermatology and Laser Specialists","San Antonio","Texas","78235",{"lat":208,"lon":209},29.42412,-98.49363,{"facility":211,"status":8,"city":212,"state":213,"zip":214,"country":215,"geoPoint":216},"Beijing Children's hospital, Capital Medical University","Beijing","Beijing Municipality","100045","China",{"lat":217,"lon":218},39.9075,116.39723,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":215,"geoPoint":224},"Shenzhen Children's Hospital","Shenzhen","Guangdong","518026",{"lat":225,"lon":226},22.54554,114.0683,{"facility":228,"status":8,"city":229,"state":230,"zip":231,"country":215,"geoPoint":232},"Hunan Children's Hospital","Changsha","Hunan","410007",{"lat":233,"lon":234},28.19874,112.97087,{"facility":236,"status":153,"city":237,"state":238,"zip":239,"country":215,"geoPoint":240},"Dermatology Hospital of Jiangxi Province","Nanchang","Jiangxi","330000",{"lat":241,"lon":242},28.68396,115.85306,{"facility":244,"status":8,"city":245,"state":246,"zip":247,"country":215,"geoPoint":248},"Hangzhou Third People's Hospital","Hangzhou","Zhejiang","310009",{"lat":249,"lon":250},30.29365,120.16142,{"facility":252,"status":8,"city":253,"zip":254,"country":215,"geoPoint":255},"Shanghai Children's Hospital","Shanghai","200062",{"lat":256,"lon":257},31.22222,121.45806,{"facility":259,"status":8,"city":253,"zip":260,"country":215,"geoPoint":261},"Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine","200092",{"lat":256,"lon":257},{"facility":263,"status":153,"city":264,"state":265,"zip":266,"country":267,"geoPoint":268},"Universitätsklinikum Münster","Münster","North Rhine-Westphalia","48149","Germany",{"lat":269,"lon":270},51.96236,7.62571,{"facility":272,"status":153,"city":273,"state":274,"zip":275,"country":267,"geoPoint":276},"Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden","Dresden","Saxony","01307",{"lat":277,"lon":278},51.05089,13.73832,{"facility":280,"status":8,"city":281,"state":282,"zip":283,"country":284,"geoPoint":285},"Pécsi Tudományegyetem Klinikai Központ","Pécs","Baranya","7632","Hungary",{"lat":286,"lon":287},46.07617,18.22814,{"facility":289,"status":8,"city":290,"state":291,"zip":292,"country":284},"Clinexpert Kft.","Budapest","Pest County","1033",{"facility":294,"status":8,"city":295,"state":296,"zip":297,"country":298,"geoPoint":299},"Queen's square Medical Facilities Queen's square Dermatology and Allergology","Yokohama","Kanagawa","220-6208","Japan",{"lat":300,"lon":301},35.43333,139.65,{"facility":303,"status":8,"city":304,"state":305,"zip":306,"country":298,"geoPoint":307},"Dermatology and Ophthalmology Kume Clinic","Sakai","Osaka","593-8324",{"lat":308,"lon":309},34.58216,135.46653,{"facility":311,"status":8,"city":312,"state":313,"zip":314,"country":298},"Sasamoto Children's Clinic","Setagaya-ku","Tokyo","157-0066",{"facility":316,"status":8,"city":317,"zip":318,"country":298,"geoPoint":319},"Fukuoka National Hospital","Fukuoka","811-1394",{"lat":320,"lon":321},33.6,130.41667,{"facility":323,"status":153,"city":317,"zip":324,"country":298,"geoPoint":325},"Saruta Dermatology Clinic","819-0042",{"lat":320,"lon":321},{"facility":327,"status":153,"city":328,"state":329,"zip":330,"country":331,"geoPoint":332},"Eukarya Pharmasite S.C.","Monterrey","Nuevo León","64718","Mexico",{"lat":333,"lon":334},25.68435,-100.31721,{"facility":336,"status":153,"city":337,"state":338,"zip":339,"country":331,"geoPoint":340},"Arké SMO S.A de C.V","Veracruz","Veracruz Ignacio de LA Llave","91900",{"lat":341,"lon":342},19.18095,-96.1429,{"facility":344,"status":153,"city":345,"zip":346,"country":331,"geoPoint":347},"Servicios Hospitalarios de Mexico S.A. DE C.V.","Chihuahua City","31238",{"lat":348,"lon":349},28.63528,-106.08889,{"facility":351,"status":8,"city":352,"state":353,"zip":354,"country":355,"geoPoint":356},"LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska","Lublin","Lublin Voivodeship","20-573","Poland",{"lat":357,"lon":358},51.25058,22.57009,{"facility":360,"status":8,"city":361,"state":362,"zip":363,"country":355,"geoPoint":364},"Centrum Medyczne Evimed","Warsaw","Masovian Voivodeship","02-625",{"lat":365,"lon":366},52.22977,21.01178,{"facility":368,"status":8,"city":369,"state":370,"zip":371,"country":355,"geoPoint":372},"DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska","Chorzów","Silesian Voivodeship","41-500",{"lat":373,"lon":374},50.30582,18.9742,{"facility":376,"status":153,"city":377,"state":370,"zip":378,"country":355,"geoPoint":379},"Centrum Medyczne Angelius Provita","Katowice","40-611",{"lat":380,"lon":381},50.2597,19.02173,{"facility":383,"status":8,"city":384,"state":385,"zip":386,"country":355,"geoPoint":387},"Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak","Lodz","Łódź Voivodeship","90-436",{"lat":388,"lon":389},51.77058,19.47395,{"facility":391,"status":8,"city":392,"state":393,"zip":394,"country":355,"geoPoint":395},"Dermedic Jacek Zdybski","Ostrowiec Świętokrzyski","Świętokrzyskie Voivodeship","27-400",{"lat":396,"lon":397},50.92936,21.38525,{"facility":399,"status":8,"city":400,"state":401,"zip":402,"country":403,"geoPoint":404},"CHUS - Hospital Clinico Universitario","Santiago de Compostela","A Coruña [LA Coruña]","15706","Spain",{"lat":405,"lon":406},42.88052,-8.54569,{"facility":408,"status":8,"city":409,"state":410,"zip":411,"country":403,"geoPoint":412},"Hospital General de Granollers","Granollers","Barcelona","08402",{"lat":413,"lon":414},41.60797,2.28773,{"facility":416,"status":8,"city":417,"zip":418,"country":403,"geoPoint":419},"Hospital Universitario Miguel Servet","Zaragoza","50009",{"lat":420,"lon":421},41.65606,-0.87734,[423],{"name":424,"role":425,"phone":426,"email":427},"Pfizer CT.gov Call Center","CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[429],{"name":424,"affiliation":13,"role":430},"STUDY_DIRECTOR",[],[433],{"label":434,"url":435},"To obtain contact information for a study center near you, click here.","https:\u002F\u002Fpmiform.com\u002Fclinical-trial-info-request?StudyID=B7451031",{"nct_id":4,"conditions":437,"biomarkers":438},[19],[],{"nct_id":4,"found":15,"summary":440,"prompt_version":450},{"design":441,"status":442,"heading":443,"summary":444,"follow_up":445,"word_count":446,"commitments":447,"compensation":448,"drugs_mentioned":449},"This is an open-label Phase 3 study, meaning everyone knows what treatment is being given. It plans to enroll about 500 participants.","completed","Long-term Study of Abrocitinib for Moderate to Severe Eczema in Children","This study is looking at the long-term safety and effectiveness of a liquid medicine called abrocitinib for children aged 2 to 11 years old who have moderate to severe atopic dermatitis (eczema). Some children in the study will have already participated in other abrocitinib studies, while others will be new to abrocitinib. All participants will receive abrocitinib oral suspension, which may be given with or without other skin medications. The main goal is to track any side effects over 24 months. The study aims to enroll about 500 children globally. The current status of the study is unclear.","The study will track adverse events for 0-24 months.",98,"Participants will receive abrocitinib oral suspension for up to 2 years. The study will track safety events over 24 months.","Not stated in the trial record.",[33],"v2"]