[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595236":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":36,"responsibleParty":416,"collaborators":24,"id":418,"slug":419,"hasResults":420,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":420,"sex":426,"minAge":427,"maxAge":428,"enrollmentInfo":429,"targetDuration":24,"studyType":432,"phases":433,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":452},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ritlecitinib higher dose","EXPERIMENTAL","Participants will receive 1 ritlecitinib higher dose capsule once a day (QD) and 1 placebo lower dose capsule QD orally for up to 3 years.\n\nParticipants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study.\n\nThose participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.",[13],"Drug: Ritlecitinib higher dose",{"label":15,"type":10,"description":16,"interventionNames":17},"Ritlecitinib lower dose","Participants will receive 1 ritlecitinib lower dose capsule once a day (QD) and 1 placebo higher dose capsule QD orally for up to 3 years.\n\nParticipants who meet the protocol-defined treatment discontinuation criteria based on not achieving the required efficacy threshold will be switched to placebo but will remain in the study.\n\nThose participants will receive 1 placebo higher dose capsule QD and 1 placebo lower dose capsule QD.",[18],"Drug: Ritlecitinib lower dose",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Study intervention will be provided as oral capsules centrally by the sponsor in HDPE bottles.",[9],null,{"type":21,"name":15,"description":22,"armGroupLabels":26,"otherNames":24},[15],[28],{"name":29,"affiliation":5,"role":30},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",[32],{"name":29,"role":33,"phone":34,"phoneExt":24,"email":35},"CONTACT","1-800-718-1021","ClinicalTrials.gov_Inquiries@pfizer.com",[37,51,61,71,81,91,101,111,116,125,135,141,147,157,167,177,187,197,206,218,228,239,248,257,263,272,281,290,302,312,322,331,343,353,363,369,375,381,387,397,406],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"California Dermatology & Clinical Research Institute","RECRUITING","Encinitas","California","92024","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-117.29198,33.03699,{"lat":49,"lon":48},{"facility":52,"status":39,"city":53,"state":54,"zip":55,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":60,"contacts":24},"Pediatric Skin Research","Miami","Florida","33156",{"type":46,"coordinates":57},[58,59],-80.19366,25.77427,{"lat":59,"lon":58},{"facility":62,"status":63,"city":64,"state":54,"zip":65,"country":43,"countryCode":44,"cosmosGeoPoint":66,"geoPoint":70,"contacts":24},"D&H Tamarac Research Center","NOT_YET_RECRUITING","Tamarac","33321",{"type":46,"coordinates":67},[68,69],-80.24977,26.21286,{"lat":69,"lon":68},{"facility":72,"status":39,"city":73,"state":74,"zip":75,"country":43,"countryCode":44,"cosmosGeoPoint":76,"geoPoint":80,"contacts":24},"Dawes Fretzin Clinical Research Group, LLC","Indianapolis","Indiana","46250",{"type":46,"coordinates":77},[78,79],-86.15804,39.76838,{"lat":79,"lon":78},{"facility":82,"status":63,"city":83,"state":84,"zip":85,"country":43,"countryCode":44,"cosmosGeoPoint":86,"geoPoint":90,"contacts":24},"Kindred Hair and Skin Center","Marriottsville","Maryland","21104",{"type":46,"coordinates":87},[88,89],-76.89942,39.3501,{"lat":89,"lon":88},{"facility":92,"status":63,"city":93,"state":94,"zip":95,"country":43,"countryCode":44,"cosmosGeoPoint":96,"geoPoint":100,"contacts":24},"Michigan Dermatology Institute","Waterford","Michigan","48328",{"type":46,"coordinates":97},[98,99],-83.41181,42.69303,{"lat":99,"lon":98},{"facility":102,"status":39,"city":103,"state":104,"zip":105,"country":43,"countryCode":44,"cosmosGeoPoint":106,"geoPoint":110,"contacts":24},"Ear, Nose & Throat Consultants, LLC","Omaha","Nebraska","68144",{"type":46,"coordinates":107},[108,109],-95.94043,41.25626,{"lat":109,"lon":108},{"facility":112,"status":39,"city":103,"state":104,"zip":105,"country":43,"countryCode":44,"cosmosGeoPoint":113,"geoPoint":115,"contacts":24},"Skin Specialists, PC dba Schlessinger MD",{"type":46,"coordinates":114},[108,109],{"lat":109,"lon":108},{"facility":117,"status":39,"city":118,"state":104,"zip":119,"country":43,"countryCode":44,"cosmosGeoPoint":120,"geoPoint":124,"contacts":24},"Complete Behavior Health (Dr. Brittany Marshall, Licensed Psychologist)","Papillion","68046",{"type":46,"coordinates":121},[122,123],-96.04224,41.15444,{"lat":123,"lon":122},{"facility":126,"status":39,"city":127,"state":128,"zip":129,"country":43,"countryCode":44,"cosmosGeoPoint":130,"geoPoint":134,"contacts":24},"University of New Mexico Health Sciences Center","Albuquerque","New Mexico","87102",{"type":46,"coordinates":131},[132,133],-106.65114,35.08449,{"lat":133,"lon":132},{"facility":136,"status":39,"city":127,"state":128,"zip":137,"country":43,"countryCode":44,"cosmosGeoPoint":138,"geoPoint":140,"contacts":24},"University of New Mexico-IDS Pharmacy","87106",{"type":46,"coordinates":139},[132,133],{"lat":133,"lon":132},{"facility":142,"status":39,"city":127,"state":128,"zip":143,"country":43,"countryCode":44,"cosmosGeoPoint":144,"geoPoint":146,"contacts":24},"Regents of the University of New Mexico","87131",{"type":46,"coordinates":145},[132,133],{"lat":133,"lon":132},{"facility":148,"status":63,"city":149,"state":150,"zip":151,"country":43,"countryCode":44,"cosmosGeoPoint":152,"geoPoint":156,"contacts":24},"Equity Medical, LLC","The Bronx","New York","10455",{"type":46,"coordinates":153},[154,155],-73.86641,40.84985,{"lat":155,"lon":154},{"facility":158,"status":39,"city":159,"state":160,"zip":161,"country":43,"countryCode":44,"cosmosGeoPoint":162,"geoPoint":166,"contacts":24},"Northwest Dermatology Institute","Portland","Oregon","97210",{"type":46,"coordinates":163},[164,165],-122.67621,45.52345,{"lat":165,"lon":164},{"facility":168,"status":63,"city":169,"state":170,"zip":171,"country":43,"countryCode":44,"cosmosGeoPoint":172,"geoPoint":176,"contacts":24},"Penn State Health Milton S. Hershey Medical Center","Hershey","Pennsylvania","17033",{"type":46,"coordinates":173},[174,175],-76.65025,40.28592,{"lat":175,"lon":174},{"facility":178,"status":63,"city":179,"state":180,"zip":181,"country":43,"countryCode":44,"cosmosGeoPoint":182,"geoPoint":186,"contacts":24},"Medical University of South Carolina Department of Dermatology and Dermatologic Surgery","Charleston","South Carolina","29425",{"type":46,"coordinates":183},[184,185],-79.93275,32.77632,{"lat":185,"lon":184},{"facility":188,"status":39,"city":189,"state":190,"zip":191,"country":43,"countryCode":44,"cosmosGeoPoint":192,"geoPoint":196,"contacts":24},"3A Research","El Paso","Texas","79902",{"type":46,"coordinates":193},[194,195],-106.48693,31.75872,{"lat":195,"lon":194},{"facility":198,"status":39,"city":199,"state":190,"zip":200,"country":43,"countryCode":44,"cosmosGeoPoint":201,"geoPoint":205,"contacts":24},"Texas Dermatology and Laser Specialists","San Antonio","78218",{"type":46,"coordinates":202},[203,204],-98.49363,29.42412,{"lat":204,"lon":203},{"facility":207,"status":39,"city":208,"state":209,"zip":210,"country":211,"countryCode":212,"cosmosGeoPoint":213,"geoPoint":217,"contacts":24},"Huashan Hospital, Fudan University","Shanghai","Shanghai Municipality","200040","China","CN",{"type":46,"coordinates":214},[215,216],121.45806,31.22222,{"lat":216,"lon":215},{"facility":219,"status":63,"city":220,"state":24,"zip":221,"country":222,"countryCode":24,"cosmosGeoPoint":223,"geoPoint":227,"contacts":24},"Prof. MUDr. Petr Arenberger, DrSc., MBA","Prague","11000","Czechia",{"type":46,"coordinates":224},[225,226],14.42076,50.08804,{"lat":226,"lon":225},{"facility":229,"status":63,"city":230,"state":24,"zip":231,"country":232,"countryCode":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":24},"Hospices Civils de Lyon - Hopital Femme Mere Enfant","Bron","69500","France","FR",{"type":46,"coordinates":235},[236,237],4.91303,45.73865,{"lat":237,"lon":236},{"facility":240,"status":63,"city":241,"state":24,"zip":242,"country":232,"countryCode":233,"cosmosGeoPoint":243,"geoPoint":247,"contacts":24},"CHU de Dijon Bourgogne","Dijon","21079",{"type":46,"coordinates":244},[245,246],5.01391,47.31344,{"lat":246,"lon":245},{"facility":249,"status":63,"city":250,"state":24,"zip":251,"country":232,"countryCode":233,"cosmosGeoPoint":252,"geoPoint":256,"contacts":24},"GHICL - Service d'investigation - Recherche clinique","Lille","59000",{"type":46,"coordinates":253},[254,255],3.05512,50.63391,{"lat":255,"lon":254},{"facility":258,"status":63,"city":250,"state":24,"zip":259,"country":232,"countryCode":233,"cosmosGeoPoint":260,"geoPoint":262,"contacts":24},"Hôpital Saint Vincent de Paul","59020",{"type":46,"coordinates":261},[254,255],{"lat":255,"lon":254},{"facility":264,"status":63,"city":265,"state":24,"zip":266,"country":232,"countryCode":233,"cosmosGeoPoint":267,"geoPoint":271,"contacts":24},"Centre Hospitalier Universitaire de Nice","Nice","06202",{"type":46,"coordinates":268},[269,270],7.26608,43.70313,{"lat":270,"lon":269},{"facility":273,"status":63,"city":274,"state":24,"zip":275,"country":232,"countryCode":233,"cosmosGeoPoint":276,"geoPoint":280,"contacts":24},"Hôpitaux Drôme Nord","Romans-sur-Isère","26100",{"type":46,"coordinates":277},[278,279],5.06602,45.0496,{"lat":279,"lon":278},{"facility":282,"status":63,"city":283,"state":24,"zip":284,"country":232,"countryCode":233,"cosmosGeoPoint":285,"geoPoint":289,"contacts":24},"Centre Hospitalier Universitaire de Toulouse - Hôpital Larrey","Toulouse","31400",{"type":46,"coordinates":286},[287,288],1.44367,43.60426,{"lat":288,"lon":287},{"facility":291,"status":63,"city":292,"state":293,"zip":294,"country":295,"countryCode":296,"cosmosGeoPoint":297,"geoPoint":301,"contacts":24},"Tohoku University Hospital","Sendai","Miyagi","980-8574","Japan","JP",{"type":46,"coordinates":298},[299,300],140.86667,38.26667,{"lat":300,"lon":299},{"facility":303,"status":39,"city":304,"state":305,"zip":306,"country":295,"countryCode":296,"cosmosGeoPoint":307,"geoPoint":311,"contacts":24},"Hamamatsu University Hospital","Hamamatsu","Shizuoka","431-3192",{"type":46,"coordinates":308},[309,310],137.73333,34.7,{"lat":310,"lon":309},{"facility":313,"status":63,"city":314,"state":315,"zip":316,"country":295,"countryCode":296,"cosmosGeoPoint":317,"geoPoint":321,"contacts":24},"Kyorin University Hospital","Mitaka","Tokyo","181-8611",{"type":46,"coordinates":318},[319,320],139.56002,35.68361,{"lat":320,"lon":319},{"facility":323,"status":39,"city":324,"state":24,"zip":325,"country":295,"countryCode":296,"cosmosGeoPoint":326,"geoPoint":330,"contacts":24},"Osaka Metropolitan University Hospital","Osaka","545-8586",{"type":46,"coordinates":327},[328,329],135.50107,34.69379,{"lat":329,"lon":328},{"facility":332,"status":63,"city":333,"state":334,"zip":335,"country":336,"countryCode":337,"cosmosGeoPoint":338,"geoPoint":342,"contacts":24},"Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak Spółka Partnerska","Wroclaw","Lower Silesian Voivodeship","50-566","Poland","PL",{"type":46,"coordinates":339},[340,341],17.03006,51.10286,{"lat":341,"lon":340},{"facility":344,"status":63,"city":345,"state":346,"zip":347,"country":336,"countryCode":337,"cosmosGeoPoint":348,"geoPoint":352,"contacts":24},"DERMEDIC Iwona Zdybska","Lublin","Lublin Voivodeship","20-607",{"type":46,"coordinates":349},[350,351],22.57009,51.25058,{"lat":351,"lon":350},{"facility":354,"status":63,"city":355,"state":356,"zip":357,"country":336,"countryCode":337,"cosmosGeoPoint":358,"geoPoint":362,"contacts":24},"Klinika Osipowicz & Turkowski","Warsaw","Masovian Voivodeship","00-716",{"type":46,"coordinates":359},[360,361],21.01178,52.22977,{"lat":361,"lon":360},{"facility":364,"status":63,"city":355,"state":356,"zip":365,"country":336,"countryCode":337,"cosmosGeoPoint":366,"geoPoint":368,"contacts":24},"Państwowy Instytut Medyczny MSWiA","02-507",{"type":46,"coordinates":367},[360,361],{"lat":361,"lon":360},{"facility":370,"status":63,"city":355,"state":356,"zip":371,"country":336,"countryCode":337,"cosmosGeoPoint":372,"geoPoint":374,"contacts":24},"Provita Poliklinika","02-647",{"type":46,"coordinates":373},[360,361],{"lat":361,"lon":360},{"facility":376,"status":63,"city":355,"state":356,"zip":377,"country":336,"countryCode":337,"cosmosGeoPoint":378,"geoPoint":380,"contacts":24},"Klinika Ambroziak Dermatologia","02-953",{"type":46,"coordinates":379},[360,361],{"lat":361,"lon":360},{"facility":382,"status":63,"city":355,"state":356,"zip":383,"country":336,"countryCode":337,"cosmosGeoPoint":384,"geoPoint":386,"contacts":24},"Royalderm Agnieszka Nawrocka","02-962",{"type":46,"coordinates":385},[360,361],{"lat":361,"lon":360},{"facility":388,"status":63,"city":389,"state":390,"zip":391,"country":336,"countryCode":337,"cosmosGeoPoint":392,"geoPoint":396,"contacts":24},"Centrum Medyczne Angelius Provita","Katowice","Silesian Voivodeship","40-611",{"type":46,"coordinates":393},[394,395],19.02173,50.2597,{"lat":395,"lon":394},{"facility":398,"status":63,"city":399,"state":24,"zip":400,"country":336,"countryCode":337,"cosmosGeoPoint":401,"geoPoint":405,"contacts":24},"Uniwersytecki Szpital kliniczny im. F. Chopina w Rzeszowie","Rzeszów","35-055",{"type":46,"coordinates":402},[403,404],21.99901,50.04132,{"lat":404,"lon":403},{"facility":407,"status":63,"city":408,"state":409,"zip":410,"country":336,"countryCode":337,"cosmosGeoPoint":411,"geoPoint":415,"contacts":24},"Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak","Lodz","Łódź Voivodeship","90-436",{"type":46,"coordinates":412},[413,414],19.47395,51.77058,{"lat":414,"lon":413},{"type":417,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100595236","phase-3-a-long-term-study-to-learn-about-the-study-medicine-called-ritlecitinib-in-children-with-severe-alopecia-areata-100595236",false,"NCT07029828","A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.","A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031","B7981028","Inclusion Criteria:\n\n1. Participants with alopecia areata (AA) (including alopecia totalis \\[AT\\] and alopecia universalis \\[AU\\]) who completed the studies B7981027 or B7981031.\n2. For participants originating from Study B7981031: At least 50% scalp hair loss due to AA (ie, a SALT score of ≥50) at both the Screening and Baseline visits.\n\nExclusion Criteria:\n\n1. Exclusion criteria for participants originating from Study B7981027 with ≤ 30 Days between last dose in Study B7981027 and first visit of Study B7981028\n\n   1. During Study B7981027 or in the period between the last dose of study intervention in Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.\n   2. Study participants discontinued from Study B7981027 due to issues other than safety-related events and considered by the investigator for enrolment in Study B7981028 must have resolution of the issue(s) resulting in discontinuation from the parent study prior to enrolment in Study B7981028.\n2. Exclusion criteria for participants originating from Study B7981031 or from Study B7981027 with \\>30 Days between last dose in Study B7981027 and first visit of Study B7981028\n\n   1. During Study B7981031 or Study B7981027 or in the period between the last dose of study intervention in Study B7981031 or Study B7981027 and the first dose of study intervention of Study B7981028, presence of safety events that would require permanent discontinuation based on the B7981028 protocol.\n   2. Any present malignancies or history of malignancies or lymphoproliferative disorders.\n   3. Evidence of untreated or inadequately treated active or latent Mycobacterium tuberculosis (TB) infection, history (one or more episodes) of severe or serious cytomegalovirus (CMV), herpes zoster (shingles) or disseminated herpes simplex, infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).\n\n      \\-","ALL","6 Years","14 Years",{"count":430,"type":431},140,"ESTIMATED","INTERVENTIONAL",[434],"PHASE3","The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.\n\nThis study is seeking participants who have:\n\n* previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031).\n* at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031).\n* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.\n\nAll participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.\n\nParticipants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.\n\nThe study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.\n\nThe study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.",[437],"Severe Alopecia Areata",[439,440,441,442],"Alopecia Areata","Children","Ritlecitinib","Long-term extension study","2026-04-23",{"date":445,"type":446},"2026-04-28","ACTUAL",{"date":448,"type":446},"2025-09-10",{"date":450,"type":431},"2030-06-26",{"name":5,"class":6},41]