[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Keros Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"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":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Duchenne Muscular Dystrophy",[28,29,30,31,32],"Recombinant fusion protein","Muscle-wasting disease","Ambulatory function","Pharmacokinetics","Pharmacodynamics","NOT_YET_RECRUITING","2026-08-06",{"date":36,"type":37},"2026-08-10","ACTUAL",{"date":39,"type":20},"2026-09-14",{"date":41,"type":20},"2029-08-14",{"name":43,"class":44},"Keros Therapeutics, Inc.","INDUSTRY",""]