[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647243":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":31,"locations":30,"responsibleParty":37,"collaborators":30,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":30,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":30,"enrollmentInfo":48,"targetDuration":30,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":30},{"fullName":5,"class":6},"Keros Therapeutics, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A1 (Late Ambulatory)","EXPERIMENTAL","Participants will receive stable corticosteroid (CS) along with KER-065.",[13],"Drug: KER-065",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort A2 (Late Ambulatory)","Participants will receive stable CS, exon skipper along with KER-065.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort N1 (Early Nonambulatory)","Participants will receive stable CS along with KER-065.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","KER-065","KER-065 will be administered subcutaneously (SC)",[9,15,19],[29],"Rinvatercept",null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Gina Weaver","CONTACT","267.799.3345","gweaver@kerostx.com",{"type":38,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100647243","safety-and-efficacy-of-ker-065-in-participants-with-duchenne-muscular-dystrophy-100647243",false,"NCT07704099","Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy","A Multicenter, Phase 2, Open-Label Study Evaluating the Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy","Key Inclusion Criteria:\n\n* Diagnosis of DMD, defined as the presence of phenotypic features at screening consistent with DMD AND documented mutation in the dystrophin gene consistent with the diagnosis of DMD using a clinically validated genetic test.\n* Receiving a stable regimen of systemic CS (including, but not limited to, prednisone, prednisolone, deflazacort, or vamorolone) for at least 90 days before screening.\n* Body weight of ≥ 25.0 kg.\n\nAmbulatory Participants Only (Cohort A1 and A2):\n\n* Ambulatory, defined as able to walk independently without assistive devices.\n* Able to TTR in \\\u003C 10 seconds.\n* Has a NSAA score ≥ 15 points.\n* Cohort 2 only: Documentation of a stable dose of an approved exon-skipping therapy.\n\nNonambulatory Participants Only (Cohort N1):\n\n* Nonambulatory, characterized as being unable to ambulate for a minimum of 3 months before first dose with onset of nonambulatory status AND a NSAA walk score of 0 and inability to perform the 10MWR.\n* PUL v2.0 entry item score of 3 to 5, inclusive.\n\nKey Exclusion Criteria:\n\n* Clinical symptoms or signs of cardiomyopathy or heart failure.\n* Exposure to any approved or investigational dystrophin restoration gene therapy product.\n* Exposure to any approved or investigational dystrophin restoration product other than gene therapy (Except for exon-skipping therapy for Cohort A2).\n* Exposure to any approved or investigational histone deacetylase inhibitor, antimyostatin therapy, therapy targeting transforming growth factor-beta ligands, or cell-based therapy.\n* Use of any other pharmacological treatment, except for CS\n* Treatment with immunosuppressant therapy (other than CS)\n* History of fracture of the upper limb\n\nNonambulatory Participants Only (Cohort N1):\n\n* Elbow-flexion contractures \\> 30° in both upper extremities.\n* Forced vital capacity (FVC) of \\\u003C 50% or requirement for daytime or nocturnal ventilation, except for nocturnal non-invasive ventilation AND inability to perform consistent FVC measurements within ± 15% during paired testing.","MALE","9 Years",{"count":49,"type":50},36,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KER-065 administered to adult and pediatric ambulatory and nonambulatory male participants with Duchenne Muscular Dystrophy (DMD) on stable background therapy.",[56],"Duchenne Muscular Dystrophy",[58,59,60,61,62],"Recombinant fusion protein","Muscle-wasting disease","Ambulatory function","Pharmacokinetics","Pharmacodynamics","NOT_YET_RECRUITING","2026-08-06",{"date":66,"type":67},"2026-08-10","ACTUAL",{"date":69,"type":50},"2026-09-14",{"date":71,"type":50},"2029-08-14",{"name":5,"class":6}]