[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638348":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":60,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":30,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":94,"overallStatus":43,"whyStopped":30,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Dyne Therapeutics","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo-Controlled Period: Zeleciment Rostudirsen (DYNE-251)","EXPERIMENTAL","Participants will be randomized to receive zeleciment rostudirsen, once every 4 weeks (Q4W) for up to 72 weeks.",[13],"Drug: Zeleciment Rostudirsen (DYNE-251)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo-Controlled Period: Placebo","PLACEBO_COMPARATOR","Participants will be randomized to receive placebo, Q4W for up to 72 weeks.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Open-Label Long-Term Extension Period: Zeleciment Rostudirsen (DYNE-251)","All participants who complete the Placebo-Controlled Period of the study will receive zeleciment rostudirsen administered Q4W for up to 96 weeks.",[13],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Zeleciment Rostudirsen (DYNE-251)","Administered by IV infusion",[21,9],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Placebo",[15],[35],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Dyne Clinical Trials","CONTACT","+1-781-317-1919","clinicaltrials@dyne-tx.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Rare Disease Research, LLC","RECRUITING","Hillsborough","North Carolina","27278","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-79.09973,36.07542,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":30,"email":59},"Hannah Nation","984-314-2252","hannah.nation@rarediseaseresearch.com",{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100638348","phase-3-efficacy-safety-and-tolerability-of-zeleciment-rostudirsen-dyne-251-administered-intravenously-every-4-weeks-in-ambulatory-participants-with-duchenne-muscular-dystrophy-forzetto-100638348",false,"NCT07608432","Efficacy, Safety, and Tolerability of Zeleciment Rostudirsen (DYNE-251) Administered Intravenously Every 4 Weeks in Ambulatory Participants With Duchenne Muscular Dystrophy (FORZETTO)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of DYNE-251 Administered Intravenously in Ambulatory Male Participants 4 to 18 Years of Age With Duchenne Muscular Dystrophy Amenable to Exon-51 Skipping","FORZETTO","Inclusion Criteria:\n\n* Ambulatory male with confirmed diagnosis of DMD and with a mutation in the dystrophin gene characterized by exon deletion amenable to exon 51 skipping .\n* Rise From Floor (RFF) time must be \\\u003C 10 seconds for both screening assessments .\n* Receiving a stable daily or weekend dosage of glucocorticoids for at least 24 weeks prior to randomization with the expectation of maintaining a stable dose during the Placebo-Controlled Period of the study (unless dose adjustment is required by weight change)\n\nExclusion Criteria:\n\n* Receipt of ongoing immunosuppressive therapy (other than glucocorticoids) within 12 weeks prior to randomization\n* Use of any pharmacologic treatment (other than glucocorticoids) that may have an effect on muscle strength or function within 12 weeks prior to randomization\n* Any change in prophylaxis\u002Ftreatment for congestive heart failure (CHF) within 12 weeks prior to randomization\n* Receipt of eteplirsen within 1 week prior to randomization\n* Receipt of alternative exon-skipping or dystrophin-modifying therapy or zeleciment rostudirsen within 24 weeks prior to randomization\n* Receipt of givinostat within 12 weeks prior to randomization\n* Receipt of gene therapy at any time\n\nNote: Other inclusion or exclusion criteria may apply","MALE","4 Years","18 Years",{"count":74,"type":75},90,"ESTIMATED","INTERVENTIONAL",[78],"PHASE3","The purpose of the study is to assess the efficacy, safety, and tolerability of zeleciment rostudirsen (DYNE-251) administered intravenously (IV) every 4 weeks to ambulatory Duchenne muscular dystrophy (DMD) participants, 4 to 18 years of age, with dystrophin mutations amenable to exon 51 skipping.",[81,82,83,84,85,86,87,88,89,90,91,92,93],"Duchenne Muscular Dystrophy (DMD)","Muscular Dystrophy, Duchenne","Muscular Dystrophy (DMD)","DMD","Muscular Dystrophies","Muscular Dystrophy in Children","Muscular Dystrophy, Duchenne Type","Muscular Dystrophy, Duchenne and Becker Types","Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)","Genetic Disease, Inborn","Genetic Disease, X-Linked","Congenital, Hereditary, and Neonatal Diseases and Abnormalities","Neuromuscular Diseases (NMD)",[95,84,96,97,98,5,99,100,101,102,68,103,104,105,106,107,108,109,110,111,112,113,114,115],"Ambulatory","Duchenne Muscular Dystrophy","Duchenne","Dyne","DYNE-251","Dystrophy","Exon Skipping","Exon 51","Pediatric","PMO","Muscle Function","Muscular Dystropy, Duchenne","Rise From Floor","RFF","RFF Velocity","Rostudirsen","Time to rise","TTR","TTR Velocity","Zeleciment rostudirsen","Z-rostudirsen","2026-05-20",{"date":118,"type":119},"2026-05-27","ACTUAL",{"date":121,"type":75},"2026-06",{"date":123,"type":75},"2032-10",{"name":5,"class":6},1]