[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491309":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":44,"responsibleParty":649,"collaborators":32,"id":651,"slug":652,"hasResults":653,"nctId":654,"briefTitle":655,"officialTitle":656,"acronym":32,"eligibilityCriteria":657,"healthyVolunteers":653,"sex":658,"minAge":659,"maxAge":660,"enrollmentInfo":661,"targetDuration":32,"studyType":664,"phases":665,"briefSummary":667,"conditions":668,"keywords":670,"overallStatus":47,"whyStopped":32,"lastUpdateSubmitDate":676,"lastUpdatePostDateStruct":677,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":685},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: LOU064 (blinded)","EXPERIMENTAL","LOU064 (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for up to 6 cycles of 24 weeks.",[13],"Drug: LOU064 (blinded)",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2: LOU064 placebo (blinded)","PLACEBO_COMPARATOR","LOU064 placebo (blinded) taken orally b.i.d. for 24 weeks (randomized in a 2:1 ratio arm 1: arm 2)",[19],"Drug: placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","LOU064 (blinded)","LOU064 (blinded) active treatment",[9],[27],"remibrutinib",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"placebo","matching active drug",[15],null,[34],{"name":35,"affiliation":35,"role":36},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":32,"email":41},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":35,"role":39,"phone":43,"phoneExt":32,"email":32},"+41613241111",[45,67,83,100,111,121,138,148,165,175,191,202,213,220,222,225,234,239,241,249,260,271,282,291,299,304,315,323,331,339,347,356,360,371,380,389,398,407,416,424,435,439,448,457,461,472,483,491,501,509,517,526,531,542,550,556,563,571,582,590,595,605,614,622,633,641],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Kern Research","RECRUITING","Bakersfield","California","93301","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-119.01871,35.37329,{"lat":57,"lon":56},[60,64],{"name":61,"role":39,"phone":62,"phoneExt":32,"email":63},"Wandy Noriega","661-864-7710","wandy.noriega@kernresearch.com",{"name":65,"role":66,"phone":32,"phoneExt":32,"email":32},"Eric Boren","PRINCIPAL_INVESTIGATOR",{"facility":68,"status":47,"city":69,"state":49,"zip":70,"country":51,"countryCode":52,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Allergy and Asthma Medical Group and Research Center","San Diego","92123",{"type":54,"coordinates":72},[73,74],-117.16472,32.71571,{"lat":74,"lon":73},[77,81],{"name":78,"role":39,"phone":79,"phoneExt":32,"email":80},"Susan Smith","858-268-2368","susansmith@allergyandasthma.com",{"name":82,"role":66,"phone":32,"phoneExt":32,"email":32},"Bob Geng",{"facility":84,"status":47,"city":85,"state":86,"zip":87,"country":51,"countryCode":52,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Pediatric Dermatology of Miami at the Pediatric CoE","Miami","Florida","33156",{"type":54,"coordinates":89},[90,91],-80.19366,25.77427,{"lat":91,"lon":90},[94,98],{"name":95,"role":39,"phone":96,"phoneExt":32,"email":97},"Andrea Marin","305-667-3152","andrea@pediatricskinresearch.com",{"name":99,"role":66,"phone":32,"phoneExt":32,"email":32},"Mercedes E Gonzalez",{"facility":101,"status":102,"city":103,"state":104,"zip":105,"country":51,"countryCode":52,"cosmosGeoPoint":106,"geoPoint":110,"contacts":32},"Treasure Valley Medical Research","ACTIVE_NOT_RECRUITING","Boise","Idaho","83706",{"type":54,"coordinates":107},[108,109],-116.20345,43.6135,{"lat":109,"lon":108},{"facility":112,"status":102,"city":113,"state":114,"zip":115,"country":51,"countryCode":52,"cosmosGeoPoint":116,"geoPoint":120,"contacts":32},"Endeavor Health","Glenview","Illinois","60077",{"type":54,"coordinates":117},[118,119],-87.78784,42.06975,{"lat":119,"lon":118},{"facility":122,"status":47,"city":123,"state":124,"zip":125,"country":51,"countryCode":52,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Allergy and Asthma Specialist P S C","Owensboro","Kentucky","42301",{"type":54,"coordinates":127},[128,129],-87.11333,37.77422,{"lat":129,"lon":128},[132,136],{"name":133,"role":39,"phone":134,"phoneExt":32,"email":135},"Angela Haynes","270-684-6144","ahaynes@cloremd.com",{"name":137,"role":66,"phone":32,"phoneExt":32,"email":32},"Lee Clore",{"facility":139,"status":102,"city":140,"state":141,"zip":142,"country":51,"countryCode":52,"cosmosGeoPoint":143,"geoPoint":147,"contacts":32},"Toledo Institute of Clinical Research","Toledo","Ohio","43617",{"type":54,"coordinates":144},[145,146],-83.55521,41.66394,{"lat":146,"lon":145},{"facility":149,"status":47,"city":150,"state":151,"zip":152,"country":51,"countryCode":52,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Allergy Asthma and Clinical Research","Oklahoma City","Oklahoma","73120",{"type":54,"coordinates":154},[155,156],-97.51643,35.46756,{"lat":156,"lon":155},[159,163],{"name":160,"role":39,"phone":161,"phoneExt":32,"email":162},"Meryem Assaoui","405-752-0393","meryem@mtarpay.com",{"name":164,"role":66,"phone":32,"phoneExt":32,"email":32},"Martha Tarpay",{"facility":166,"status":102,"city":167,"state":168,"zip":169,"country":51,"countryCode":52,"cosmosGeoPoint":170,"geoPoint":174,"contacts":32},"Allergy and Clinical Immunology Associates","Pittsburgh","Pennsylvania","15241",{"type":54,"coordinates":171},[172,173],-79.99589,40.44062,{"lat":173,"lon":172},{"facility":176,"status":47,"city":177,"state":178,"zip":179,"country":51,"countryCode":52,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"RFSA Dermatology","San Antonio","Texas","78213",{"type":54,"coordinates":181},[182,183],-98.49363,29.42412,{"lat":183,"lon":182},[186,189],{"name":187,"role":39,"phone":32,"phoneExt":32,"email":188},"Jonathan Joseph","jvjoseph007@gmail.com",{"name":190,"role":66,"phone":32,"phoneExt":32,"email":32},"Lindsey Finklea",{"facility":192,"status":193,"city":194,"state":195,"zip":196,"country":51,"countryCode":52,"cosmosGeoPoint":197,"geoPoint":201,"contacts":32},"Allergy Associates of Utah","COMPLETED","Sandy City","Utah","84093",{"type":54,"coordinates":198},[199,200],-111.8841,40.59161,{"lat":200,"lon":199},{"facility":203,"status":204,"city":205,"state":206,"zip":207,"country":51,"countryCode":52,"cosmosGeoPoint":208,"geoPoint":212,"contacts":32},"Seattle Allergy and Asthma Rsch","WITHDRAWN","Seattle","Washington","98115",{"type":54,"coordinates":209},[210,211],-122.33207,47.60621,{"lat":211,"lon":210},{"facility":214,"status":47,"city":215,"state":216,"zip":217,"country":218,"countryCode":219,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"Novartis Investigative Site","CABA","Buenos Aires","1280","Argentina","AR",{"facility":214,"status":102,"city":215,"state":216,"zip":221,"country":218,"countryCode":219,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"C1414AIF",{"facility":214,"status":47,"city":223,"state":216,"zip":224,"country":218,"countryCode":219,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"Caba","C1425BEN",{"facility":214,"status":47,"city":226,"state":227,"zip":228,"country":218,"countryCode":219,"cosmosGeoPoint":229,"geoPoint":233,"contacts":32},"Rosario","Santa Fe Province","2000",{"type":54,"coordinates":230},[231,232],-60.63932,-32.94682,{"lat":232,"lon":231},{"facility":214,"status":47,"city":226,"state":227,"zip":235,"country":218,"countryCode":219,"cosmosGeoPoint":236,"geoPoint":238,"contacts":32},"S2000JKR",{"type":54,"coordinates":237},[231,232],{"lat":232,"lon":231},{"facility":214,"status":102,"city":215,"state":32,"zip":240,"country":218,"countryCode":219,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"C1181ACH",{"facility":214,"status":102,"city":242,"state":32,"zip":243,"country":218,"countryCode":219,"cosmosGeoPoint":244,"geoPoint":248,"contacts":32},"San Miguel de Tucumán","4000",{"type":54,"coordinates":245},[246,247],-65.21051,-26.81601,{"lat":247,"lon":246},{"facility":214,"status":47,"city":250,"state":251,"zip":252,"country":253,"countryCode":254,"cosmosGeoPoint":255,"geoPoint":259,"contacts":32},"Montreal","Quebec","H4A 3J1","Canada","CA",{"type":54,"coordinates":256},[257,258],-73.58781,45.50884,{"lat":258,"lon":257},{"facility":214,"status":102,"city":261,"state":262,"zip":263,"country":264,"countryCode":265,"cosmosGeoPoint":266,"geoPoint":270,"contacts":32},"Santiago","Santiago Metropolitan","8420383","Chile","CL",{"type":54,"coordinates":267},[268,269],-70.64827,-33.45694,{"lat":269,"lon":268},{"facility":214,"status":102,"city":272,"state":273,"zip":274,"country":275,"countryCode":276,"cosmosGeoPoint":277,"geoPoint":281,"contacts":32},"Guangzhou","Guangdong","510091","China","CN",{"type":54,"coordinates":278},[279,280],113.25,23.11667,{"lat":280,"lon":279},{"facility":214,"status":102,"city":283,"state":284,"zip":285,"country":275,"countryCode":276,"cosmosGeoPoint":286,"geoPoint":290,"contacts":32},"Chengdu","Sichuan","610041",{"type":54,"coordinates":287},[288,289],104.06667,30.66667,{"lat":289,"lon":288},{"facility":214,"status":47,"city":292,"state":32,"zip":293,"country":275,"countryCode":276,"cosmosGeoPoint":294,"geoPoint":298,"contacts":32},"Beijing","100050",{"type":54,"coordinates":295},[296,297],116.39723,39.9075,{"lat":297,"lon":296},{"facility":214,"status":102,"city":292,"state":32,"zip":300,"country":275,"countryCode":276,"cosmosGeoPoint":301,"geoPoint":303,"contacts":32},"100069",{"type":54,"coordinates":302},[296,297],{"lat":297,"lon":296},{"facility":214,"status":102,"city":305,"state":306,"zip":307,"country":308,"countryCode":309,"cosmosGeoPoint":310,"geoPoint":314,"contacts":32},"Frankfurt am Main","Hesse","60590","Germany","DE",{"type":54,"coordinates":311},[312,313],8.68417,50.11552,{"lat":313,"lon":312},{"facility":214,"status":193,"city":316,"state":32,"zip":317,"country":308,"countryCode":309,"cosmosGeoPoint":318,"geoPoint":322,"contacts":32},"Berlin","13353",{"type":54,"coordinates":319},[320,321],13.41053,52.52437,{"lat":321,"lon":320},{"facility":214,"status":204,"city":324,"state":32,"zip":325,"country":308,"countryCode":309,"cosmosGeoPoint":326,"geoPoint":330,"contacts":32},"Mainz","55131",{"type":54,"coordinates":327},[328,329],8.28008,49.98185,{"lat":329,"lon":328},{"facility":214,"status":47,"city":332,"state":32,"zip":333,"country":308,"countryCode":309,"cosmosGeoPoint":334,"geoPoint":338,"contacts":32},"Münster","48149",{"type":54,"coordinates":335},[336,337],7.62571,51.96236,{"lat":337,"lon":336},{"facility":214,"status":193,"city":340,"state":32,"zip":341,"country":308,"countryCode":309,"cosmosGeoPoint":342,"geoPoint":346,"contacts":32},"Tübingen","72076",{"type":54,"coordinates":343},[344,345],9.05222,48.52266,{"lat":345,"lon":344},{"facility":214,"status":47,"city":348,"state":32,"zip":349,"country":348,"countryCode":350,"cosmosGeoPoint":351,"geoPoint":355,"contacts":32},"Hong Kong","999077","HK",{"type":54,"coordinates":352},[353,354],114.17469,22.27832,{"lat":354,"lon":353},{"facility":214,"status":102,"city":348,"state":32,"zip":349,"country":348,"countryCode":350,"cosmosGeoPoint":357,"geoPoint":359,"contacts":32},{"type":54,"coordinates":358},[353,354],{"lat":354,"lon":353},{"facility":214,"status":47,"city":361,"state":362,"zip":363,"country":364,"countryCode":365,"cosmosGeoPoint":366,"geoPoint":370,"contacts":32},"Bari","BA","70126","Italy","IT",{"type":54,"coordinates":367},[368,369],16.86982,41.12066,{"lat":369,"lon":368},{"facility":214,"status":102,"city":372,"state":373,"zip":374,"country":364,"countryCode":365,"cosmosGeoPoint":375,"geoPoint":379,"contacts":32},"Florence","FI","50139",{"type":54,"coordinates":376},[377,378],11.24626,43.77925,{"lat":378,"lon":377},{"facility":214,"status":102,"city":381,"state":382,"zip":383,"country":364,"countryCode":365,"cosmosGeoPoint":384,"geoPoint":388,"contacts":32},"Parma","PR","43126",{"type":54,"coordinates":385},[386,387],10.32618,44.79935,{"lat":387,"lon":386},{"facility":214,"status":102,"city":390,"state":391,"zip":392,"country":364,"countryCode":365,"cosmosGeoPoint":393,"geoPoint":397,"contacts":32},"Pavia","PV","27100",{"type":54,"coordinates":394},[395,396],9.15917,45.19205,{"lat":396,"lon":395},{"facility":214,"status":102,"city":399,"state":400,"zip":401,"country":364,"countryCode":365,"cosmosGeoPoint":402,"geoPoint":406,"contacts":32},"Siena","SI","53100",{"type":54,"coordinates":403},[404,405],11.33064,43.31822,{"lat":405,"lon":404},{"facility":214,"status":47,"city":408,"state":409,"zip":410,"country":364,"countryCode":365,"cosmosGeoPoint":411,"geoPoint":415,"contacts":32},"Trieste","TS","34137",{"type":54,"coordinates":412},[413,414],13.77678,45.64953,{"lat":414,"lon":413},{"facility":214,"status":47,"city":417,"state":32,"zip":418,"country":364,"countryCode":365,"cosmosGeoPoint":419,"geoPoint":423,"contacts":32},"Naples","80138",{"type":54,"coordinates":420},[421,422],14.26811,40.85216,{"lat":422,"lon":421},{"facility":214,"status":102,"city":425,"state":426,"zip":427,"country":428,"countryCode":429,"cosmosGeoPoint":430,"geoPoint":434,"contacts":32},"Kitakyushu","Fukuoka","8078556","Japan","JP",{"type":54,"coordinates":431},[432,433],130.85034,33.85181,{"lat":433,"lon":432},{"facility":214,"status":102,"city":436,"state":437,"zip":438,"country":428,"countryCode":429,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"Kamimashi-gun","Kumamoto","861-3106",{"facility":214,"status":102,"city":440,"state":441,"zip":442,"country":428,"countryCode":429,"cosmosGeoPoint":443,"geoPoint":447,"contacts":32},"Sakai","Osaka","5938324",{"type":54,"coordinates":444},[445,446],135.46653,34.58216,{"lat":446,"lon":445},{"facility":214,"status":102,"city":449,"state":450,"zip":451,"country":428,"countryCode":429,"cosmosGeoPoint":452,"geoPoint":456,"contacts":32},"Izumo","Shimane","6938501",{"type":54,"coordinates":453},[454,455],132.76667,35.36667,{"lat":455,"lon":454},{"facility":214,"status":193,"city":458,"state":459,"zip":460,"country":428,"countryCode":429,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"Itabashi-ku","Tokyo","1738610",{"facility":214,"status":102,"city":462,"state":463,"zip":464,"country":465,"countryCode":466,"cosmosGeoPoint":467,"geoPoint":471,"contacts":32},"Kuching","Sarawak","93586","Malaysia","MY",{"type":54,"coordinates":468},[469,470],110.33333,1.55,{"lat":470,"lon":469},{"facility":214,"status":204,"city":473,"state":474,"zip":475,"country":476,"countryCode":477,"cosmosGeoPoint":478,"geoPoint":482,"contacts":32},"Deventer","Overijssel","7416 SE","Netherlands","NL",{"type":54,"coordinates":479},[480,481],6.16389,52.255,{"lat":481,"lon":480},{"facility":214,"status":102,"city":484,"state":32,"zip":485,"country":476,"countryCode":477,"cosmosGeoPoint":486,"geoPoint":490,"contacts":32},"Utrecht","3584 CX",{"type":54,"coordinates":487},[488,489],5.12222,52.09083,{"lat":489,"lon":488},{"facility":214,"status":102,"city":492,"state":32,"zip":493,"country":494,"countryCode":495,"cosmosGeoPoint":496,"geoPoint":500,"contacts":32},"Lodz","90-436","Poland","PL",{"type":54,"coordinates":497},[498,499],19.47395,51.77058,{"lat":499,"lon":498},{"facility":214,"status":204,"city":502,"state":32,"zip":503,"country":494,"countryCode":495,"cosmosGeoPoint":504,"geoPoint":508,"contacts":32},"Olsztyn","10-045",{"type":54,"coordinates":505},[506,507],20.49272,53.78376,{"lat":507,"lon":506},{"facility":214,"status":204,"city":510,"state":32,"zip":511,"country":494,"countryCode":495,"cosmosGeoPoint":512,"geoPoint":516,"contacts":32},"Warsaw","02-962",{"type":54,"coordinates":513},[514,515],21.01178,52.22977,{"lat":515,"lon":514},{"facility":214,"status":204,"city":518,"state":32,"zip":519,"country":518,"countryCode":520,"cosmosGeoPoint":521,"geoPoint":525,"contacts":32},"Singapore","119074","SG",{"type":54,"coordinates":522},[523,524],103.85007,1.28967,{"lat":524,"lon":523},{"facility":214,"status":204,"city":518,"state":32,"zip":527,"country":518,"countryCode":520,"cosmosGeoPoint":528,"geoPoint":530,"contacts":32},"229899",{"type":54,"coordinates":529},[523,524],{"lat":524,"lon":523},{"facility":214,"status":102,"city":532,"state":533,"zip":534,"country":535,"countryCode":536,"cosmosGeoPoint":537,"geoPoint":541,"contacts":32},"Pretoria","Gauteng","0181","South Africa","ZA",{"type":54,"coordinates":538},[539,540],28.18783,-25.74486,{"lat":540,"lon":539},{"facility":214,"status":102,"city":543,"state":32,"zip":544,"country":535,"countryCode":536,"cosmosGeoPoint":545,"geoPoint":549,"contacts":32},"Cape Town","7925",{"type":54,"coordinates":546},[547,548],18.42322,-33.92584,{"lat":548,"lon":547},{"facility":214,"status":102,"city":551,"state":552,"zip":553,"country":554,"countryCode":555,"cosmosGeoPoint":32,"geoPoint":32,"contacts":32},"Esplugues","Barcelona","08950","Spain","ES",{"facility":214,"status":204,"city":552,"state":32,"zip":557,"country":554,"countryCode":555,"cosmosGeoPoint":558,"geoPoint":562,"contacts":32},"08035",{"type":54,"coordinates":559},[560,561],2.15899,41.38879,{"lat":561,"lon":560},{"facility":214,"status":102,"city":564,"state":32,"zip":565,"country":554,"countryCode":555,"cosmosGeoPoint":566,"geoPoint":570,"contacts":32},"Valencia","46014",{"type":54,"coordinates":567},[568,569],-0.37966,39.47391,{"lat":569,"lon":568},{"facility":214,"status":102,"city":572,"state":573,"zip":574,"country":575,"countryCode":576,"cosmosGeoPoint":577,"geoPoint":581,"contacts":32},"Songkhla","Hat Yai","90110","Thailand","TH",{"type":54,"coordinates":578},[579,580],100.5951,7.19882,{"lat":580,"lon":579},{"facility":214,"status":102,"city":583,"state":32,"zip":584,"country":575,"countryCode":576,"cosmosGeoPoint":585,"geoPoint":589,"contacts":32},"Bangkok","10330",{"type":54,"coordinates":586},[587,588],100.50144,13.75398,{"lat":588,"lon":587},{"facility":214,"status":102,"city":583,"state":32,"zip":591,"country":575,"countryCode":576,"cosmosGeoPoint":592,"geoPoint":594,"contacts":32},"10700",{"type":54,"coordinates":593},[587,588],{"lat":588,"lon":587},{"facility":214,"status":102,"city":596,"state":597,"zip":598,"country":599,"countryCode":32,"cosmosGeoPoint":600,"geoPoint":604,"contacts":32},"Istanbul","Fatih","34093","Turkey (Türkiye)",{"type":54,"coordinates":601},[602,603],28.94966,41.01384,{"lat":603,"lon":602},{"facility":214,"status":102,"city":606,"state":607,"zip":608,"country":599,"countryCode":32,"cosmosGeoPoint":609,"geoPoint":613,"contacts":32},"Ankara","Sihhiye-Altindag","06230",{"type":54,"coordinates":610},[611,612],32.85427,39.91987,{"lat":612,"lon":611},{"facility":214,"status":102,"city":615,"state":32,"zip":616,"country":599,"countryCode":32,"cosmosGeoPoint":617,"geoPoint":621,"contacts":32},"Adana","01330",{"type":54,"coordinates":618},[619,620],35.32531,36.98615,{"lat":620,"lon":619},{"facility":214,"status":102,"city":623,"state":624,"zip":625,"country":626,"countryCode":627,"cosmosGeoPoint":628,"geoPoint":632,"contacts":32},"Peterborough","Cambridgeshire","PE3 9GZ","United Kingdom","UK",{"type":54,"coordinates":629},[630,631],-0.24777,52.57364,{"lat":631,"lon":630},{"facility":214,"status":102,"city":634,"state":32,"zip":635,"country":626,"countryCode":627,"cosmosGeoPoint":636,"geoPoint":640,"contacts":32},"Manchester","M13 9WL",{"type":54,"coordinates":637},[638,639],-2.23743,53.48095,{"lat":639,"lon":638},{"facility":214,"status":102,"city":642,"state":32,"zip":643,"country":626,"countryCode":627,"cosmosGeoPoint":644,"geoPoint":648,"contacts":32},"Southampton","SO16 6YD",{"type":54,"coordinates":645},[646,647],-1.40428,50.90395,{"lat":647,"lon":646},{"type":650,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100491309","phase-3-24-weeks-double-blind-randomized-placebo-controlled-trial-to-evaluate-efficacy-pk-safety-of-lou064-in-adolescents-12---18-with-csu-and-inadequate-response-to-h1-antihistamine-followed-by-optional-3-years-open-label-extension-and-an-optional-3-years-safety-long-term-treatment-free-follow-up-100491309",false,"NCT05677451","24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - \u003C18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up","A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 Years","Key Inclusion Criteria:\n\n* Male and female adolescent participants aged \\>= 12 to \\\u003C 18 years of age at the time of signing the informed consent\n* CSU duration for \\>= 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation)\n* Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as:\n* The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines\n* UAS7 score (range 0 - 42) \\>= 16, ISS7 score (range 0 - 21) \\>= 6 and HSS7 score (range 0 - 21) \\>= 6 during the 7 days prior to randomization (Day 1)\n* Documentation of hives within three months before randomization (either at screening and\u002For at randomization; or documented in the participants' medical history)\n\nKey Exclusion criteria:\n\n* Previous use of remibrutinib or other BTK inhibitors\n* Significant bleeding risk or coagulation disorders\n* History of gastrointestinal bleeding\n* Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg\u002Fd or clopidogrel up to 75 mg\u002Fd. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited\n* History or current hepatic disease\n* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant\n* History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes\n* Participants having a clearly defined predominant or sole trigger of their chronic urticaria (chronic inducible urticaria) including urticaria factitia (symptomatic dermographism), cold-, heat-, solar-, pressure-, delayed pressure-, aquagenic-, cholinergic-, or contact-urticaria\n* Other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary angioedema, or drug-induced urticaria\n* Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","12 Years","17 Years",{"count":662,"type":663},100,"ESTIMATED","INTERVENTIONAL",[666],"PHASE3","The purpose of this trial is:\n\n1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \\\u003C 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines\n2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment\n3. to collect safety data in this population for up to three years after the last dose of study treatment",[669],"Chronic Spontaneous Urticaria",[671,672,673,674,675],"BTK inhibitor","Chronic spontaneous urticaria","Urticaria activity score","Hives severity score","Itch severity score","2026-06-04",{"date":678,"type":679},"2026-06-05","ACTUAL",{"date":681,"type":679},"2023-07-11",{"date":683,"type":663},"2032-03-30",{"name":35,"class":6},66]