[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591087":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":16,"studyPopulation":16,"armGroups":48,"interventions":59,"overallOfficials":16,"centralContacts":68,"locations":75,"responsibleParty":630,"collaborators":16,"id":632,"slug":633,"hasResults":634,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":634,"sex":640,"minAge":641,"maxAge":642,"enrollmentInfo":643,"targetDuration":16,"studyType":646,"phases":647,"briefSummary":649,"conditions":650,"keywords":16,"overallStatus":78,"whyStopped":16,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":661},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Annualized rate of clinical VOC","Calculated from total number of clinical VOC incidents and total number of days during the observation period","At Week 52",[14,18,20,22,25,27,29,31,33,35],{"measure":15,"description":16,"timeFrame":17},"Time to first clinical VOC incidence",null,"Until Week 52",{"measure":19,"description":16,"timeFrame":12},"Annualized rate of visits due to SCD-related complications as assessed by the Investigator",{"measure":21,"description":16,"timeFrame":12},"Annualized rate of home-managed VOCs as reported in the Sickle Cell Pain Crisis (SCPC) eDiary",{"measure":23,"description":16,"timeFrame":24},"Change in fatigue as measured by the PROMIS SF v1.0 Fatigue 13a total score (adults)","From baseline to Week 52",{"measure":26,"description":16,"timeFrame":24},"Change in Hb levels",{"measure":28,"description":16,"timeFrame":24},"Change in fatigue as measured by the PedsQL Multidimensional Fatigue Scale total score (pediatric participants)",{"measure":30,"description":16,"timeFrame":17},"Incidence of treatment emergent adverse events (TEAEs), including serious adverse events (SAEs), adverse events of special interest (AESIs) and adverse events leading to discontinuation",{"measure":32,"description":16,"timeFrame":17},"Incidence of potentially clinically significant laboratory, vital signs, and ECG abnormalities",{"measure":34,"description":16,"timeFrame":17},"Absolute number of simple and exchange blood transfusion",{"measure":36,"description":16,"timeFrame":17},"Number of days requiring acetaminophen, NSAID and\u002For short-acting opioid usage",{"allocation":38,"interventionModel":39,"interventionModelDescription":16,"primaryPurpose":40,"observationalModel":16,"timePerspective":16,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":16,"whoMasked":43},"QUADRUPLE",[44,45,46,47],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[49,54],{"label":50,"type":51,"description":50,"interventionNames":52},"Rilzabrutinib","EXPERIMENTAL",[53],"Drug: Rilzabrutinib",{"label":55,"type":56,"description":55,"interventionNames":57},"Placebo","PLACEBO_COMPARATOR",[58],"Drug: Placebo",[60,66],{"type":61,"name":50,"description":62,"armGroupLabels":63,"otherNames":64},"DRUG","Pharmaceutical form:Tablet -Route of administration:Oral",[50],[65],"SAR444671",{"type":61,"name":55,"description":62,"armGroupLabels":67,"otherNames":16},[55],[69],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","contact-us@sanofi.com",[76,90,100,110,120,129,139,149,159,169,179,189,199,208,218,228,238,249,255,264,276,286,296,305,313,324,333,342,351,362,371,382,387,396,407,412,421,426,448,458,477,494,514,533,548,559,570,581,587,597,602,611,623],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":16},"University of Alabama at Birmingham- Site Number : 8400003","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-86.80249,33.52066,{"lat":88,"lon":87},{"facility":91,"status":78,"city":92,"state":93,"zip":94,"country":82,"countryCode":83,"cosmosGeoPoint":95,"geoPoint":99,"contacts":16},"Phoenix Children's Hospital- Site Number : 8400028","Phoenix","Arizona","85016",{"type":85,"coordinates":96},[97,98],-112.07404,33.44838,{"lat":98,"lon":97},{"facility":101,"status":78,"city":102,"state":103,"zip":104,"country":82,"countryCode":83,"cosmosGeoPoint":105,"geoPoint":109,"contacts":16},"University of California San Francisco- Site Number : 8400040","Fresno","California","93701",{"type":85,"coordinates":106},[107,108],-119.77237,36.74773,{"lat":108,"lon":107},{"facility":111,"status":78,"city":112,"state":113,"zip":114,"country":82,"countryCode":83,"cosmosGeoPoint":115,"geoPoint":119,"contacts":16},"Oncology & Hematology Associates of West Broward- Site Number : 8400029","Coral Springs","Florida","33065",{"type":85,"coordinates":116},[117,118],-80.2706,26.27119,{"lat":118,"lon":117},{"facility":121,"status":78,"city":122,"state":113,"zip":123,"country":82,"countryCode":83,"cosmosGeoPoint":124,"geoPoint":128,"contacts":16},"Sylvester Comprehensive Cancer Center- Site Number : 8400020","Miami","33136",{"type":85,"coordinates":125},[126,127],-80.19366,25.77427,{"lat":127,"lon":126},{"facility":130,"status":78,"city":131,"state":132,"zip":133,"country":82,"countryCode":83,"cosmosGeoPoint":134,"geoPoint":138,"contacts":16},"University of Illinois-Chicago - College of Medicine- Site Number : 8400054","Chicago","Illinois","60612",{"type":85,"coordinates":135},[136,137],-87.65005,41.85003,{"lat":137,"lon":136},{"facility":140,"status":78,"city":141,"state":142,"zip":143,"country":82,"countryCode":83,"cosmosGeoPoint":144,"geoPoint":148,"contacts":16},"Indiana University Health Riley Hospital for Children- Site Number : 8400056","Indianapolis","Indiana","46202",{"type":85,"coordinates":145},[146,147],-86.15804,39.76838,{"lat":147,"lon":146},{"facility":150,"status":78,"city":151,"state":152,"zip":153,"country":82,"countryCode":83,"cosmosGeoPoint":154,"geoPoint":158,"contacts":16},"Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037","Shreveport","Louisiana","71130",{"type":85,"coordinates":155},[156,157],-93.75018,32.52515,{"lat":157,"lon":156},{"facility":160,"status":78,"city":161,"state":162,"zip":163,"country":82,"countryCode":83,"cosmosGeoPoint":164,"geoPoint":168,"contacts":16},"University of Maryland School of Medicine - Baltimore- Site Number : 8400041","Baltimore","Maryland","21201",{"type":85,"coordinates":165},[166,167],-76.61219,39.29038,{"lat":167,"lon":166},{"facility":170,"status":78,"city":171,"state":172,"zip":173,"country":82,"countryCode":83,"cosmosGeoPoint":174,"geoPoint":178,"contacts":16},"University of Michigan Health System - Ann Arbor- Site Number : 8400035","Ann Arbor","Michigan","48109",{"type":85,"coordinates":175},[176,177],-83.74088,42.27756,{"lat":177,"lon":176},{"facility":180,"status":78,"city":181,"state":182,"zip":183,"country":82,"countryCode":83,"cosmosGeoPoint":184,"geoPoint":188,"contacts":16},"Southern Specialty Research- Site Number : 8400059","Flowood","Mississippi","39232",{"type":85,"coordinates":185},[186,187],-90.13898,32.30959,{"lat":187,"lon":186},{"facility":190,"status":78,"city":191,"state":192,"zip":193,"country":82,"countryCode":83,"cosmosGeoPoint":194,"geoPoint":198,"contacts":16},"Richmond University Medical Center- Site Number : 8400038","Staten Island","New York","10310",{"type":85,"coordinates":195},[196,197],-74.13986,40.56233,{"lat":197,"lon":196},{"facility":200,"status":78,"city":201,"state":192,"zip":202,"country":82,"countryCode":83,"cosmosGeoPoint":203,"geoPoint":207,"contacts":16},"Montefiore Medical Center - Moses Campus- Site Number : 8400057","The Bronx","10467",{"type":85,"coordinates":204},[205,206],-73.86641,40.84985,{"lat":206,"lon":205},{"facility":209,"status":78,"city":210,"state":211,"zip":212,"country":82,"countryCode":83,"cosmosGeoPoint":213,"geoPoint":217,"contacts":16},"Prisma Health- Site Number : 8400051","Greenville","South Carolina","29605",{"type":85,"coordinates":214},[215,216],-82.39401,34.85262,{"lat":216,"lon":215},{"facility":219,"status":78,"city":220,"state":221,"zip":222,"country":82,"countryCode":83,"cosmosGeoPoint":223,"geoPoint":227,"contacts":16},"Baylor College of Medicine- Site Number : 8400055","Houston","Texas","77030",{"type":85,"coordinates":224},[225,226],-95.36327,29.76328,{"lat":226,"lon":225},{"facility":229,"status":78,"city":230,"state":231,"zip":232,"country":82,"countryCode":83,"cosmosGeoPoint":233,"geoPoint":237,"contacts":16},"VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400012","Richmond","Virginia","23298",{"type":85,"coordinates":234},[235,236],-77.46026,37.55376,{"lat":236,"lon":235},{"facility":239,"status":78,"city":240,"state":16,"zip":241,"country":242,"countryCode":243,"cosmosGeoPoint":244,"geoPoint":248,"contacts":16},"Investigational Site Number : 0560003","Brussels","1020","Belgium","BE",{"type":85,"coordinates":245},[246,247],4.34878,50.85045,{"lat":247,"lon":246},{"facility":250,"status":78,"city":240,"state":16,"zip":251,"country":242,"countryCode":243,"cosmosGeoPoint":252,"geoPoint":254,"contacts":16},"Investigational Site Number : 0560002","1070",{"type":85,"coordinates":253},[246,247],{"lat":247,"lon":246},{"facility":256,"status":78,"city":257,"state":16,"zip":258,"country":242,"countryCode":243,"cosmosGeoPoint":259,"geoPoint":263,"contacts":16},"Investigational Site Number : 0560001","Leuven","3000",{"type":85,"coordinates":260},[261,262],4.70093,50.87959,{"lat":262,"lon":261},{"facility":265,"status":78,"city":266,"state":267,"zip":268,"country":269,"countryCode":270,"cosmosGeoPoint":271,"geoPoint":275,"contacts":16},"Hospital Santa Izabel- Site Number : 0760006","Salvador","Estado de Bahia","40050-410","Brazil","BR",{"type":85,"coordinates":272},[273,274],-38.49096,-12.97563,{"lat":274,"lon":273},{"facility":277,"status":78,"city":278,"state":279,"zip":280,"country":269,"countryCode":270,"cosmosGeoPoint":281,"geoPoint":285,"contacts":16},"Universidade Federal de Goias- Site Number : 0760002","Goiânia","Goiás","74605-020",{"type":85,"coordinates":282},[283,284],-49.25389,-16.67861,{"lat":284,"lon":283},{"facility":287,"status":78,"city":288,"state":289,"zip":290,"country":269,"countryCode":270,"cosmosGeoPoint":291,"geoPoint":295,"contacts":16},"Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760001","São José do Rio Preto","São Paulo","15090-000",{"type":85,"coordinates":292},[293,294],-49.37944,-20.81972,{"lat":294,"lon":293},{"facility":297,"status":78,"city":298,"state":16,"zip":299,"country":269,"countryCode":270,"cosmosGeoPoint":300,"geoPoint":304,"contacts":16},"Pontifícia Universidade Católica do Rio de Janeiro- Site Number : 0760009","Rio de Janeiro","22451-900",{"type":85,"coordinates":301},[302,303],-43.18223,-22.90642,{"lat":303,"lon":302},{"facility":306,"status":78,"city":289,"state":16,"zip":307,"country":269,"countryCode":270,"cosmosGeoPoint":308,"geoPoint":312,"contacts":16},"Hospital Samaritano De Sao Paulo- Site Number : 0760005","01232-010",{"type":85,"coordinates":309},[310,311],-46.63611,-23.5475,{"lat":311,"lon":310},{"facility":314,"status":78,"city":315,"state":16,"zip":316,"country":317,"countryCode":318,"cosmosGeoPoint":319,"geoPoint":323,"contacts":16},"Investigational Site Number : 2500002","Créteil","94010","France","FR",{"type":85,"coordinates":320},[321,322],2.46569,48.79266,{"lat":322,"lon":321},{"facility":325,"status":78,"city":326,"state":16,"zip":327,"country":317,"countryCode":318,"cosmosGeoPoint":328,"geoPoint":332,"contacts":16},"Investigational Site Number : 2500005","Marseille","13885",{"type":85,"coordinates":329},[330,331],5.38107,43.29695,{"lat":331,"lon":330},{"facility":334,"status":78,"city":335,"state":16,"zip":336,"country":317,"countryCode":318,"cosmosGeoPoint":337,"geoPoint":341,"contacts":16},"Investigational Site Number : 2500001","Paris","75015",{"type":85,"coordinates":338},[339,340],2.3488,48.85341,{"lat":340,"lon":339},{"facility":343,"status":78,"city":344,"state":16,"zip":345,"country":317,"countryCode":318,"cosmosGeoPoint":346,"geoPoint":350,"contacts":16},"Investigational Site Number : 2500004","Toulouse","31100",{"type":85,"coordinates":347},[348,349],1.44367,43.60426,{"lat":349,"lon":348},{"facility":352,"status":78,"city":353,"state":16,"zip":354,"country":355,"countryCode":356,"cosmosGeoPoint":357,"geoPoint":361,"contacts":16},"Investigational Site Number : 2760002","Essen","45147","Germany","DE",{"type":85,"coordinates":358},[359,360],7.01228,51.45657,{"lat":360,"lon":359},{"facility":363,"status":78,"city":364,"state":16,"zip":365,"country":355,"countryCode":356,"cosmosGeoPoint":366,"geoPoint":370,"contacts":16},"Investigational Site Number : 2760004","Stuttgart","70736",{"type":85,"coordinates":367},[368,369],9.17702,48.78232,{"lat":369,"lon":368},{"facility":372,"status":78,"city":373,"state":16,"zip":374,"country":375,"countryCode":376,"cosmosGeoPoint":377,"geoPoint":381,"contacts":16},"Investigational Site Number : 3000001","Athens","115 27","Greece","GR",{"type":85,"coordinates":378},[379,380],23.72784,37.98376,{"lat":380,"lon":379},{"facility":383,"status":78,"city":373,"state":16,"zip":374,"country":375,"countryCode":376,"cosmosGeoPoint":384,"geoPoint":386,"contacts":16},"Investigational Site Number : 3000003",{"type":85,"coordinates":385},[379,380],{"lat":380,"lon":379},{"facility":388,"status":78,"city":389,"state":16,"zip":390,"country":375,"countryCode":376,"cosmosGeoPoint":391,"geoPoint":395,"contacts":16},"Investigational Site Number : 3000002","Pátrai","265 04",{"type":85,"coordinates":392},[393,394],21.73508,38.2462,{"lat":394,"lon":393},{"facility":397,"status":78,"city":398,"state":16,"zip":399,"country":400,"countryCode":401,"cosmosGeoPoint":402,"geoPoint":406,"contacts":16},"Investigational Site Number : 3760001","Afula","1834111","Israel","IL",{"type":85,"coordinates":403},[404,405],35.2892,32.60907,{"lat":405,"lon":404},{"facility":408,"status":78,"city":398,"state":16,"zip":399,"country":400,"countryCode":401,"cosmosGeoPoint":409,"geoPoint":411,"contacts":16},"Investigational Site Number : 3760002",{"type":85,"coordinates":410},[404,405],{"lat":405,"lon":404},{"facility":413,"status":78,"city":414,"state":16,"zip":415,"country":400,"countryCode":401,"cosmosGeoPoint":416,"geoPoint":420,"contacts":16},"Investigational Site Number : 3760005","Haifa","3109601",{"type":85,"coordinates":417},[418,419],34.99928,32.81303,{"lat":419,"lon":418},{"facility":422,"status":78,"city":414,"state":16,"zip":415,"country":400,"countryCode":401,"cosmosGeoPoint":423,"geoPoint":425,"contacts":16},"Investigational Site Number : 3760006",{"type":85,"coordinates":424},[418,419],{"lat":419,"lon":418},{"facility":427,"status":78,"city":428,"state":429,"zip":430,"country":431,"countryCode":432,"cosmosGeoPoint":433,"geoPoint":437,"contacts":438},"Azienda Ospedaliero Universitaria Careggi SOD Ematologia-Site Number : 3800006","Florence","Firenze","50134","Italy","IT",{"type":85,"coordinates":434},[435,436],11.24626,43.77925,{"lat":436,"lon":435},[439,443,446],{"name":440,"role":71,"phone":441,"phoneExt":16,"email":442},"Valentina Carrai","055 7949777","carraiv@aou-careggi.toscana",{"name":444,"role":71,"phone":441,"phoneExt":16,"email":445},"Silvia Querceto","silvia.querceto@unifi.it",{"name":440,"role":447,"phone":16,"phoneExt":16,"email":16},"PRINCIPAL_INVESTIGATOR",{"facility":449,"status":78,"city":450,"state":451,"zip":452,"country":431,"countryCode":432,"cosmosGeoPoint":453,"geoPoint":457,"contacts":16},"Investigational Site Number : 3800004","Milan","Milano","20122",{"type":85,"coordinates":454},[455,456],9.18951,45.46427,{"lat":456,"lon":455},{"facility":459,"status":78,"city":460,"state":461,"zip":462,"country":431,"countryCode":432,"cosmosGeoPoint":463,"geoPoint":467,"contacts":468},"Azienda Ospedaliera Universitaria, Università della Campania \"Luigi Vanvitelli\" Napoli-Site Number : 3800005","Naples","Napoli","80138",{"type":85,"coordinates":464},[465,466],14.26811,40.85216,{"lat":466,"lon":465},[469,473,476],{"name":470,"role":71,"phone":471,"phoneExt":16,"email":472},"Silverio Perrotta","+390815664185","silverio.perrotta@unicampania.it",{"name":474,"role":71,"phone":471,"phoneExt":16,"email":475},"Laura Pinfildi","pinfildilaura@gmail.com",{"name":470,"role":447,"phone":16,"phoneExt":16,"email":16},{"facility":478,"status":78,"city":479,"state":480,"zip":481,"country":431,"countryCode":432,"cosmosGeoPoint":482,"geoPoint":486,"contacts":487},"IRCCS Ospedale Pediatrico Bambino Gesù-Site Number : 3800001","Rome","Roma","00165",{"type":85,"coordinates":483},[484,485],12.51133,41.89193,{"lat":485,"lon":484},[488,492],{"name":489,"role":71,"phone":490,"phoneExt":16,"email":491},"Centro Trial Oncoematologico","+390668593697","centrotrial-oncoematologico@opbg.net",{"name":493,"role":447,"phone":16,"phoneExt":16,"email":16},"Franco Locatelli",{"facility":495,"status":78,"city":496,"state":497,"zip":498,"country":431,"countryCode":432,"cosmosGeoPoint":499,"geoPoint":503,"contacts":504},"Azienda Ospedaliera Universitaria San Luigi Gonzaga, SSD Microcitemie Malattie Rare Ematologiche-Site Number : 3800007","Orbassano","Torino","10043",{"type":85,"coordinates":500},[501,502],7.53813,45.00547,{"lat":502,"lon":501},[505,509,513],{"name":506,"role":71,"phone":507,"phoneExt":16,"email":508},"Rosa Maria Catena De Maria","+393398110707","rosamaria.demaria@unito.it",{"name":510,"role":71,"phone":511,"phoneExt":16,"email":512},"Vincenzo Voi","+390119026852","vincenzo.voi@unito.it",{"name":510,"role":447,"phone":16,"phoneExt":16,"email":16},{"facility":515,"status":78,"city":516,"state":16,"zip":517,"country":431,"countryCode":432,"cosmosGeoPoint":518,"geoPoint":522,"contacts":523},"Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello-Site Number : 3800002","Palermo","90146",{"type":85,"coordinates":519},[520,521],13.3636,38.1166,{"lat":521,"lon":520},[524,528,532],{"name":525,"role":71,"phone":526,"phoneExt":16,"email":527},"Rosario Di Maggio","+390917802034","rdm83@hotmail.it",{"name":529,"role":71,"phone":530,"phoneExt":16,"email":531},"Alessandro Inzerillo","+393277653510","aleinzerillo22@gmail.com",{"name":525,"role":447,"phone":16,"phoneExt":16,"email":16},{"facility":534,"status":78,"city":535,"state":16,"zip":536,"country":431,"countryCode":432,"cosmosGeoPoint":537,"geoPoint":541,"contacts":542},"Centro Ricerche Cliniche Verona s.r.l. presso Ospedale G.B. Rossi Borgo Roma-Site Number : 3800003","Verona","37134",{"type":85,"coordinates":538},[539,540],10.9938,45.43854,{"lat":540,"lon":539},[543,547],{"name":544,"role":71,"phone":545,"phoneExt":16,"email":546},"Lucia De Franceschi","+390458124918","filippo.mazzi@aovr.veneto.it",{"name":544,"role":447,"phone":16,"phoneExt":16,"email":16},{"facility":549,"status":78,"city":550,"state":16,"zip":551,"country":552,"countryCode":553,"cosmosGeoPoint":554,"geoPoint":558,"contacts":16},"Investigational Site Number : 5280002","Rotterdam","3015 CE","Netherlands","NL",{"type":85,"coordinates":555},[556,557],4.47917,51.9225,{"lat":557,"lon":556},{"facility":560,"status":78,"city":561,"state":16,"zip":562,"country":563,"countryCode":564,"cosmosGeoPoint":565,"geoPoint":569,"contacts":16},"Investigational Site Number : 5120001","Muscat","123","Oman","OM",{"type":85,"coordinates":566},[567,568],58.40778,23.58413,{"lat":568,"lon":567},{"facility":571,"status":78,"city":572,"state":16,"zip":573,"country":574,"countryCode":575,"cosmosGeoPoint":576,"geoPoint":580,"contacts":16},"Investigational Site Number : 7240002","Madrid","28007","Spain","ES",{"type":85,"coordinates":577},[578,579],-3.70256,40.4165,{"lat":579,"lon":578},{"facility":582,"status":78,"city":572,"state":16,"zip":583,"country":574,"countryCode":575,"cosmosGeoPoint":584,"geoPoint":586,"contacts":16},"Investigational Site Number : 7240001","28046",{"type":85,"coordinates":585},[578,579],{"lat":579,"lon":578},{"facility":588,"status":78,"city":589,"state":16,"zip":590,"country":591,"countryCode":16,"cosmosGeoPoint":592,"geoPoint":596,"contacts":16},"Investigational Site Number : 7920001","Adana","01330","Turkey (Türkiye)",{"type":85,"coordinates":593},[594,595],35.32531,36.98615,{"lat":595,"lon":594},{"facility":598,"status":78,"city":589,"state":16,"zip":590,"country":591,"countryCode":16,"cosmosGeoPoint":599,"geoPoint":601,"contacts":16},"Investigational Site Number : 7920002",{"type":85,"coordinates":600},[594,595],{"lat":595,"lon":594},{"facility":603,"status":78,"city":604,"state":16,"zip":605,"country":591,"countryCode":16,"cosmosGeoPoint":606,"geoPoint":610,"contacts":16},"Investigational Site Number : 7920003","Mersin","33330",{"type":85,"coordinates":607},[608,609],34.63886,36.81196,{"lat":609,"lon":608},{"facility":612,"status":78,"city":613,"state":614,"zip":615,"country":616,"countryCode":617,"cosmosGeoPoint":618,"geoPoint":622,"contacts":16},"Investigational Site Number : 8260002","London","Harrow","NW10 7NS","United Kingdom","UK",{"type":85,"coordinates":619},[620,621],-0.12574,51.50853,{"lat":621,"lon":620},{"facility":624,"status":78,"city":613,"state":625,"zip":626,"country":616,"countryCode":617,"cosmosGeoPoint":627,"geoPoint":629,"contacts":16},"Investigational Site Number : 8260001","London, City of","SE5 9RL",{"type":85,"coordinates":628},[620,621],{"lat":621,"lon":620},{"type":631,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100591087","phase-3-the-efficacy-and-safety-of-rilzabrutinib-in-participants-aged-10-to-65-years-with-sickle-cell-disease-100591087",false,"NCT06975865","The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Flexible-adaptive, Group Sequential Study to Evaluate the Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","LIBRA","Inclusion Criteria:\n\n* Participants who have been diagnosed with SCD.\n* Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.\n* Participants who are either not on hydroxyurea and\u002For L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and\u002For L-glutamine for a minimum of 6 months. Participants on hydroxyurea and\u002For L-glutamine must have been on a stable weight-based dose level (mg\u002Fkg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons.\n* Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* For participants ≥10 to \\\u003C18 years of age: the parent(s)\u002Flegal guardian(s) must provide written informed consent prior to any study-related procedures being performed.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply: Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.\n* Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings.\n* Participants with history of stroke, or history of abnormal transcranial doppler.\n* Participants with uncontrolled or active HBV infection and\u002For HCV infection including those receiving antiviral therapy at the time of screening.\n* HIV infection.\n* A history of active or latent tuberculosis (TB)\n* Positive COVID-19 molecular test.\n* Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and\u002For voxelotor (OXBRYTA®) within 30 days prior to the Screening visit.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","10 Years","65 Years",{"count":644,"type":645},192,"ESTIMATED","INTERVENTIONAL",[648],"PHASE3","This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and safety of rilzabrutinib in participants with sickle-cell disease (SCD).\n\nStudy details include:\n\n* Study duration: a 52-week double-blind period (Part A), followed by an open-label LTE period (Part B). Double-blind period has two parts, 50% (adult only) until the interim analysis (a proof-concept part analogous to a phase 2b study), and 50% (adult and children) after the interim analysis. Only the participants who complete double-blind treatment period (Part A) are eligible to continue to the LTE period. The duration of the LTE period (Part B) will be from the first-participant-in (FPI)-LTE (Part B) until the last participant who enters the LTE has completed 52 weeks.\n* Treatment duration: 52-week double-blind period (Part A); LTE period (Part B) from the (FPI until the last participant who enters the LTE has completed 52 weeks.\n* Visit frequency: Week visits based on the Schedule of Assessments.",[651],"Sickle Cell Disease","2026-07-28",{"date":654,"type":655},"2026-07-29","ACTUAL",{"date":657,"type":655},"2025-08-12",{"date":659,"type":645},"2028-12-29",{"name":5,"class":6},53]