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Immunologia Clinica e Allergologia Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona","Salerno","84131",{"type":193,"coordinates":651},[652,653],14.79328,40.67545,{"lat":653,"lon":652},{"facility":656,"status":186,"city":657,"state":11,"zip":658,"country":602,"countryCode":603,"cosmosGeoPoint":659,"geoPoint":663,"contacts":11},"Unità Operativa di Allergologia Azienda Ospedaliera Universitaria Integrata di Verona","Verona","37126",{"type":193,"coordinates":660},[661,662],10.9938,45.43854,{"lat":662,"lon":661},{"facility":665,"status":186,"city":666,"state":667,"zip":668,"country":669,"countryCode":670,"cosmosGeoPoint":671,"geoPoint":675,"contacts":11},"ErasmusMC","Rotterdam","South Holland","3015 GD","Netherlands","NL",{"type":193,"coordinates":672},[673,674],4.47917,51.9225,{"lat":674,"lon":673},{"facility":677,"status":186,"city":678,"state":11,"zip":679,"country":669,"countryCode":670,"cosmosGeoPoint":680,"geoPoint":684,"contacts":11},"University Medical Center Groningen","Groningen","9713 GZ",{"type":193,"coordinates":681},[682,683],6.56667,53.21917,{"lat":683,"lon":682},{"facility":686,"status":186,"city":687,"state":11,"zip":688,"country":689,"countryCode":690,"cosmosGeoPoint":691,"geoPoint":695,"contacts":11},"Oslo University Hospital","Oslo","N-0424","Norway","NO",{"type":193,"coordinates":692},[693,694],10.74609,59.91273,{"lat":694,"lon":693},{"facility":697,"status":186,"city":698,"state":11,"zip":699,"country":700,"countryCode":701,"cosmosGeoPoint":702,"geoPoint":706,"contacts":11},"Uniwersyteckie Centrum Kliniczne Klinika Alergologii","Gdansk","80-214","Poland","PL",{"type":193,"coordinates":703},[704,705],18.64912,54.35227,{"lat":705,"lon":704},{"facility":708,"status":186,"city":709,"state":11,"zip":710,"country":711,"countryCode":712,"cosmosGeoPoint":713,"geoPoint":717,"contacts":11},"Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo Antonio dos Capuchos","Lisbon","1169-050","Portugal","PT",{"type":193,"coordinates":714},[715,716],-9.1498,38.72509,{"lat":716,"lon":715},{"facility":719,"status":186,"city":720,"state":11,"zip":721,"country":711,"countryCode":712,"cosmosGeoPoint":722,"geoPoint":726,"contacts":11},"CHUPorto, EPE - Hospital de Santo António","Porto","4099-001",{"type":193,"coordinates":723},[724,725],-8.61097,41.1485,{"lat":725,"lon":724},{"facility":728,"status":186,"city":720,"state":11,"zip":729,"country":711,"countryCode":712,"cosmosGeoPoint":730,"geoPoint":732,"contacts":11},"Centro Hospitalar Universitario Sao Joao, E.P.E.","4200-139",{"type":193,"coordinates":731},[724,725],{"lat":725,"lon":724},{"facility":734,"status":186,"city":735,"state":11,"zip":11,"country":736,"countryCode":737,"cosmosGeoPoint":738,"geoPoint":742,"contacts":11},"Hospital Universitario Vall d'Hebron","Barcelona","Spain","ES",{"type":193,"coordinates":739},[740,741],2.15899,41.38879,{"lat":741,"lon":740},{"facility":744,"status":186,"city":745,"state":11,"zip":746,"country":736,"countryCode":737,"cosmosGeoPoint":747,"geoPoint":751,"contacts":11},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":193,"coordinates":748},[749,750],-3.70256,40.4165,{"lat":750,"lon":749},{"facility":753,"status":186,"city":754,"state":11,"zip":755,"country":736,"countryCode":737,"cosmosGeoPoint":756,"geoPoint":760,"contacts":11},"Hospital Virgen del Valle - Instituto de Estudios de Mastocitosis de Castilla-La Mancha","Toledo","45071",{"type":193,"coordinates":757},[758,759],-4.02263,39.8581,{"lat":759,"lon":758},{"facility":762,"status":186,"city":763,"state":11,"zip":764,"country":765,"countryCode":766,"cosmosGeoPoint":767,"geoPoint":771,"contacts":11},"Uppsala University Hospital","Uppsala","751 85","Sweden","SE",{"type":193,"coordinates":768},[769,770],17.63889,59.85882,{"lat":770,"lon":769},{"facility":773,"status":186,"city":774,"state":11,"zip":775,"country":776,"countryCode":777,"cosmosGeoPoint":778,"geoPoint":782,"contacts":11},"University Hospital Basel","Basel","C-4031","Switzerland","CH",{"type":193,"coordinates":779},[780,781],7.57327,47.55839,{"lat":781,"lon":780},{"facility":784,"status":186,"city":785,"state":11,"zip":786,"country":776,"countryCode":777,"cosmosGeoPoint":787,"geoPoint":791,"contacts":11},"Luzerner Kantonsspital","Lucerne","6000",{"type":193,"coordinates":788},[789,790],8.30635,47.05048,{"lat":790,"lon":789},{"facility":793,"status":186,"city":794,"state":11,"zip":795,"country":796,"countryCode":11,"cosmosGeoPoint":797,"geoPoint":801,"contacts":11},"lstanbul Universitesi lstanbul Tip Fakultesi Hastanesi","Istanbul","34093","Turkey (Türkiye)",{"type":193,"coordinates":798},[799,800],28.94966,41.01384,{"lat":800,"lon":799},{"facility":803,"status":186,"city":804,"state":11,"zip":805,"country":796,"countryCode":11,"cosmosGeoPoint":806,"geoPoint":810,"contacts":11},"Mersin VM Medikal Park Hastanesi","Mersin","33200",{"type":193,"coordinates":807},[808,809],34.63886,36.81196,{"lat":809,"lon":808},{"facility":812,"status":186,"city":813,"state":814,"zip":815,"country":816,"countryCode":817,"cosmosGeoPoint":818,"geoPoint":822,"contacts":11},"University Hospital of Wales","Cardiff","Wales","CF14 4XW","United Kingdom","UK",{"type":193,"coordinates":819},[820,821],-3.18,51.48,{"lat":821,"lon":820},{"facility":812,"status":186,"city":813,"state":11,"zip":815,"country":816,"countryCode":817,"cosmosGeoPoint":824,"geoPoint":826,"contacts":11},{"type":193,"coordinates":825},[820,821],{"lat":821,"lon":820},{"facility":828,"status":186,"city":829,"state":11,"zip":830,"country":816,"countryCode":817,"cosmosGeoPoint":831,"geoPoint":835,"contacts":11},"University College London Hospitals (UCLH), Haematology Cancer Clinical Trials Unit","London","NW1 2PG",{"type":193,"coordinates":832},[833,834],-0.12574,51.50853,{"lat":834,"lon":833},{"facility":837,"status":186,"city":829,"state":11,"zip":838,"country":816,"countryCode":817,"cosmosGeoPoint":839,"geoPoint":841,"contacts":11},"Guy's and St Thomas's NHS Foundation Trust","SE1 7EH",{"type":193,"coordinates":840},[833,834],{"lat":834,"lon":833},{"facility":843,"status":186,"city":844,"state":11,"zip":845,"country":816,"countryCode":817,"cosmosGeoPoint":846,"geoPoint":850,"contacts":11},"Cancer and Haematology Centre","Oxford","OX3 7LE",{"type":193,"coordinates":847},[848,849],-1.25596,51.75222,{"lat":849,"lon":848},{"facility":852,"status":186,"city":853,"state":11,"zip":854,"country":816,"countryCode":817,"cosmosGeoPoint":855,"geoPoint":859,"contacts":11},"University Hospital Plymouth NHS Trust","Plymouth","PL6 8DH",{"type":193,"coordinates":856},[857,858],-4.14305,50.37153,{"lat":858,"lon":857},{"type":861,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100432405",false,"NCT04910685","(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis","A Randomized, Double-Blind, Placebo-Controlled Phase 2\u002F3 Study of BLU-263 in Indolent Systemic Mastocytosis","Key Inclusion Criteria:\n\nAll Participants:\n\n-Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.\n\nPart 1 and PK groups:\n\n* Participant has confirmed diagnosis of ISM, confirmed by Central Pathology Review\n* Participant must have failed to achieve adequate symptom control for 1 or more Baseline symptoms, as determined by the Investigator, with at least 2 of the following symptom-directed therapies administered: H1 blockers, H2 blockers, proton-pump inhibitors, leukotriene inhibitors, cromolyn sodium, corticosteroids, or omalizumab.\n* Participants must have SDT for ISM symptom management stabilized for at least 14 days prior to starting screening procedures.\n* For participants receiving corticosteroids, the dose must be ≤ 20 mg\u002Fday prednisone or equivalent, and the dose must be stable for ≥ 14 days.\n\nPart K:\n\n-Participant has confirmed diagnosis of ISM, confirmed by Central Pathology Review\n\nPart S:\n\n-Participant has confirmed diagnosis of SSM, confirmed by Central Pathology Review of BM biopsy and central review of B- and C-findings by WHO diagnostic criteria.\n\nPart 2:\n\n-Participant has confirmed diagnosis of ISM, confirmed by Central Pathology Review\n\nKey Exclusion Criteria:\n\n* Participant has been diagnosed with any of the following WHO systemic mastocytosis (SM) sub-classifications: cutaneous mastocytosis only, SM with an associated hematologic neoplasm of non-MC lineage (SM-AHN), aggressive SM, mast cell leukemia, or mast cell sarcoma.\n* Participant has been diagnosed with another myeloproliferative disorder.\n* Participant has organ damage attributable to SM.\n* Participant has clinically significant, uncontrolled, cardiovascular disease\n* Participant has a QT interval corrected using Fridericia's formula (QTcF) \\> \\> 470 milliseconds (msec) (for females) or \\> 450 msec (for males).\n* Participant has a history of a primary malignancy that has been diagnosed or required therapy within 3 years. The following prior malignancies are not exclusionary: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.\n* Time since any cytoreductive therapy including masitinib and midostaurin should be at least 5 half-lives or 14 days (whichever is longer), and for cladribine, interferon alpha, pegylated interferon, or antibody therapy \\\u003C 28 days or 5 half-lives of the drug (whichever is longer), before beginning the screening period.\n* Participant has received radiotherapy or psoralen and ultraviolet A (PUVA) therapy \\\u003C 14 days before beginning the screening period.\n\nOther protocol-defined criteria apply.","ALL","18 Years",{"count":871,"type":872},534,"ESTIMATED","INTERVENTIONAL",[875,876],"PHASE2","PHASE3","This is a randomized, double-blind, placebo-controlled, Phase 2\u002F3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by SDT. Parts 1 and 2 will enroll participants with ISM. Participants enrolled in Part 2 will roll over onto Part 3 to receive treatment with elenestinib in an open-label fashion following completion of the earlier Part. Part K will enroll participants with ISM who have previously received an approved selective KIT inhibitor. The study also includes pharmacokinetic (PK) groups that will enroll participants with ISM.",[879,880],"Indolent Systemic Mastocytosis","Smoldering Systemic Mastocytosis",[882,883],"ISM","SSM","2026-06-23",{"date":886,"type":887},"2026-06-25","ACTUAL",{"date":889,"type":887},"2021-11-30",{"date":891,"type":872},"2032-09-30",{"name":5,"class":6},71]