[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"facioscapulohumeral-muscular-dystrophy-type-1-fshd1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:facioscapulohumeral-muscular-dystrophy-type-1-fshd1":39},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":14,"conditions":26,"keywords":44,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100595880","phase-3-a-study-to-evaluate-del-brax-also-referred-to-as-aoc-1020-in-participants-with-fshd-100595880",false,"NCT07038200","A Study to Evaluate Del-brax (Also Referred to as AOC 1020) in Participants With FSHD","A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1020 for the Treatment of Facioscapulohumeral Muscular Dystrophy (FSHD)","FORTITUDE-3","Inclusion Criteria:\n\n* Clinical and genetic diagnosis of FSHD1 or FSHD2\n* Ability to walk independently at pre-specified walking speed (orthoses and ankle braces allowed) for at least 10 meters at screening\n* Adequate muscle strength based on QMT composite score\n\nExclusion Criteria:\n\n* Breastfeeding, pregnancy, or intent to become pregnant during the study\n* Unwilling or unable to comply with contraceptive requirements\n* Abnormal lab values, conditions or diseases that would make the participant unsuitable for the study\n* Blood Pressure \\> 140\u002F90 mmHg at Screening\n* Treatment with another investigational drug or biological agent within 1 month of Screening or 5 half-lives of the drug, whichever is longer\n* Treatment with an oligonucleotide within 9 months of Screening","ALL","16 Years","70 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Facioscapulohumeral Muscular Dystrophy","FSHD","FSHD - Facioscapulohumeral Muscular Dystrophy","FSHD1","FSHD2","Fascioscapulohumeral Muscular Dystrophy","Fascioscapulohumeral Muscular Dystrophy Type 1","Fascioscapulohumeral Muscular Dystrophy Type 2","Facioscapulohumeral Muscular Dystrophy 1","Facioscapulohumeral Dystrophy","Facio-Scapulo-Humeral Dystrophy","Facioscapulohumeral Muscular Dystrophy 2","Facioscapulohumeral Muscular Dystrophy Type 1 (FSHD1)","FSH Muscular Dystrophy","Landouzy Dejerine Dystrophy","Landouzy-Dejerine Muscular Dystrophy","Landouzy-Dejerine Syndrome",[45,46,47,48,49,50,51,52,15,53,54,55],"Avidity","Avidity Biosciences","del-brax","del brax","delbrax","AOC1020","AOC 1020","delpacibart braxlosiran","FORTITUDE Phase 3","FORTITUDE","FORTITUDE 3","RECRUITING","2026-05-27",{"date":59,"type":60},"2026-05-29","ACTUAL",{"date":62,"type":60},"2025-06-10",{"date":64,"type":22},"2028-07",{"name":66,"class":67},"Avidity Biosciences, Inc.","INDUSTRY",46,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100390842","a-registered-cohort-study-on-fshd1-100390842","NCT04369209","A Registered Cohort Study on FSHD1","A Registered Observational Cohort Study of Facioscapulohumeral Muscular Dystrophy Type 1","Inclusion Criteria:\n\n* Male or female subjects of all ages at baseline\n* Subjects, with or without symptoms, with FSHD1 genetic confirmation through PFGE-based Southern blotting\n* Unrelated healthy controls\n\nExclusion Criteria:\n\n* Decline to participate\n* Other neuromuscular disease (such as Limb-girdle muscular dystrophy or Myotonic dystrophy)\n* Serious systemic illness (such as heart, liver, kidney disease or major mental illness)",true,{"count":78,"type":22},1000,"OBSERVATIONAL","The data to be collected is intended to help healthcare providers make important medical and financial decisions concerning FSHD1, through an enhanced understanding of the prevalence, progression and natural history of FSHD1.",[39],"2024-08-23",{"date":84,"type":60},"2024-08-26",{"date":86,"type":60},"2001-01",{"date":88,"type":22},"2031-12",{"name":90,"class":91},"Ning Wang, MD., PhD.","OTHER",1]