{"entity":{"id":"nct04910685","kind":"trial","name":"(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis","aka":["HARBOR"],"tldr":"A phase 2/3 trial testing Elenestinib in systemic mastocytosis, now recruiting.","summary":"(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis is a phase 2/3 interventional study registered as NCT04910685, led by Blueprint Medicines, and recruiting on the registry. Official title: A Randomised, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis. Planned enrolment is 534 participants (estimated). The study started in 2021-11-30 and primary completion is expected in 2032-09-30. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT04910685","url":"https://clinicaltrials.gov/study/NCT04910685"}],"tags":["ctgov-ingest"],"related":[],"cancers":["systemic-mastocytosis","indolent-systemic-mastocytosis"],"sections":[],"technologies":[],"targets":[],"drugs":["elenestinib"],"companies":["sanofi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04910685","phase":"2/3","setting":"A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of BLU-263 in Indolent Systemic Mastocytosis","sponsor":"Blueprint Medicines","participation":[{"nct":"NCT04910685","source":"https://clinicaltrials.gov/study/NCT04910685","fetchedAt":"2026-10-07T16:53:30.019Z","studySha256":"68a4336d639498032f2887958964d23af2e44cd2c9319c0e51f61e8d855e4a38","overallStatus":"RECRUITING","lastUpdatePosted":"2026-10-07","leadSponsor":"Blueprint Medicines Corporation","collaboratorCount":0,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":534,"enrolmentType":"ESTIMATED","siteCount":88,"recruitingSiteCount":88,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Chile","Colombia","Czechia","Denmark","France","Germany","Greece","Ireland","Italy","Netherlands","Norway","Poland","Portugal","Romania","Spain","Sweden","Switzerland","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2021-11-30","startedType":"actual","enrolled":534,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct04910685/","neighbours":{"cancer":[{"id":"indolent-systemic-mastocytosis","kind":"cancer","name":"Indolent and smouldering systemic mastocytosis","route":"/cancers/indolent-systemic-mastocytosis/"},{"id":"systemic-mastocytosis","kind":"cancer","name":"Systemic mastocytosis","route":"/cancers/systemic-mastocytosis/"}],"drug":[{"id":"elenestinib","kind":"drug","name":"Elenestinib","route":"/drugs/elenestinib/"}],"company":[{"id":"sanofi","kind":"company","name":"Sanofi","route":"/companies/sanofi/"}]}}