[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"exon-44\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:exon-44":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100515784",false,"NCT05996003","NS-089\u002FNCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)","A Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of NS-089\u002FNCNP-02 in Boys With Duchenne Muscular Dystrophy (DMD)","Inclusion Criteria:\n\n* Male ≥ 4 years and \\\u003C15 years of age\n* Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 44 to restore the dystrophin mRNA reading frame\n* Able to walk independently without assistive devices\n* Ability to complete the TTSTAND without assistance in \\\u003C20 seconds\n* Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study.\n* Other inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Has a body weight of \\\u003C20 kg at the time of informed consent (applies to participants screening for Part 1 only)\n* Evidence of symptomatic cardiomyopathy\n* Current or previous treatment with anabolic steroids (e.g., oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug\n* Current or previous treatment with any other investigational drug within 3 months prior to the first dose of study drug or within 5 times the half-life of a medication, whichever is longer\n* Surgery within the 3 months prior to the first dose of study drug or planned during the study duration\n* Previously treated in an interventional study of NS-089\u002FNCNP-02\n* Having received exon skipping oligonucleotide within 1 year prior to the first dose of IP\n* Other exclusion criteria may apply.","MALE","4 Years","14 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2, open-label, multi-center, 2-part study of NS-089\u002FNCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \\\u003C15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089\u002FNCNP-02 administered once weekly.\n\nThe study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2.",[26,27,28],"Duchenne Muscular Dystrophy","Exon 44","DMD",[30,28,31],"Exon 44 Skipping","Brogidirsen","RECRUITING","2026-03-04",{"date":35,"type":36},"2026-03-06","ACTUAL",{"date":38,"type":36},"2024-02-22",{"date":40,"type":20},"2026-09-11",{"name":42,"class":43},"NS Pharma, Inc.","INDUSTRY",25,""]