[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658961":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":11,"studyPopulation":11,"armGroups":45,"interventions":52,"overallOfficials":59,"centralContacts":63,"locations":11,"responsibleParty":68,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":11},{"fullName":5,"class":6},"H. Lundbeck A\u002FS","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Number of Participants with Treatment-emergent Adverse Events (TEAEs)",null,"Up to 42 months",[14,16,19,21,23,25,27,29,31,34,36],{"measure":15,"description":11,"timeFrame":12},"Serum Concentration of Asedebart",{"measure":17,"description":11,"timeFrame":18},"Area Under the Asedebart Serum Concentration-time Curve in a Dosing Interval (AUC0-tau)","Up to 73 days",{"measure":20,"description":11,"timeFrame":18},"Area Under the Asedebart Serum Concentration-time Curve From Start of Injection to 28 days Post-dose (AUC0-4W)",{"measure":22,"description":11,"timeFrame":18},"Maximum Observed Serum Concentration of Asedebart (Cmax)",{"measure":24,"description":11,"timeFrame":18},"Nominal Time Corresponding to the Occurrence of Cmax of Asedebart (Tmax)",{"measure":26,"description":11,"timeFrame":18},"Minimum Observed Serum Concentration of Asedebart (Ctrough)",{"measure":28,"description":11,"timeFrame":18},"Nominal Time Corresponding to the Occurrence of Ctrough (Ttrough)",{"measure":30,"description":11,"timeFrame":12},"Number of Participants with Anti-drug Antibodies (ADAs) Following Dosing",{"measure":32,"description":11,"timeFrame":33},"Relative Reduction from Baseline in Morning Concentrations of Androstenedione (A4) in Blood","Baseline, Month 12, 24, and 36",{"measure":35,"description":11,"timeFrame":33},"Relative Reduction from Baseline in Morning Concentrations of 17-hydroxyprogesterone (17-OHP) in Blood",{"measure":37,"description":11,"timeFrame":33},"Relative Reduction from Baseline in Morning Concentrations of Glucocorticoid (GC) Daily Dose",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":11,"timePerspective":11,"maskingInfo":43},"NA","SEQUENTIAL","The trial will begin with a pharmacokinetic (PK) Period, which will include participants in Cohort 1. Following completion of the PK Period, participants in Cohort 1 will continue their trial participation in the Main Treatment Period. Participants in Cohorts 2 and 3 will enter the trial in the Main Treatment Period. All participants will attend the Completion Visit after last study drug administration.","TREATMENT",{"masking":44,"maskingDescription":11,"whoMasked":11},"NONE",[46],{"label":47,"type":48,"description":49,"interventionNames":50},"Asedebart","EXPERIMENTAL","Participants will receive asedebart per a prespecified dosing schedule.",[51],"Drug: Asedebart",[53],{"type":54,"name":47,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Solution for injection\u002Finfusion",[47],[58],"Lu AG13909",[60],{"name":61,"affiliation":5,"role":62},"Email contact via H. Lundbeck A\u002FS","STUDY_DIRECTOR",[64],{"name":61,"role":65,"phone":66,"phoneExt":11,"email":67},"CONTACT","+45 36301311","HQ_Medinfo@Lundbeck.com",{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658961","phase-2-an-extension-trial-of-asedebart-in-participants-with-congenital-adrenal-hyperplasia-100658961",false,"NCT07859293","An Extension Trial of Asedebart in Participants With Congenital Adrenal Hyperplasia","Interventional, Open-label, Extension Trial of Asedebart (Lu AG13909) in Participants With Congenital Adrenal Hyperplasia","Key Inclusion Criteria:\n\n* The participant has been treated with asedebart in a clinical trial.\n* The participant had an acceptable benefit-risk assessment in the prior trial and would benefit from continued treatment with asedebart in the opinion of the investigator.\n* For participants with \\> 12 weeks since their last dose of asedebart: The participant has been on a stable daily dose of GC replacement therapy of ≥ 8 milligram per square meter (mg\u002Fm\\^2) (adjusted for body surface area in hydrocortisone equivalent dosage \\[HCe\\]) for \\>= 1 month prior to the Screening Visit.\n* For participants with \\> 12 weeks since their last dose of asedebart: The participant is not adequately controlled on their current treatment and, at the Screening\u002FBaseline Visit, has either:\n\n  * elevated androgen blood concentrations (A4 \\> upper limit of normal (ULN) for age and sex) in morning measurements (pre-GC replacement dose) OR\n  * androgen blood concentrations within the reference range (A4 \\\u003C= ULN for age and sex) and is being treated with supraphysiological GC (GC daily dose \\> 13 mg\u002Fm\\^2 adjusted for body surface area in HCe)\n\nKey Exclusion Criteria:\n\n* The participant has known hypersensitivity or intolerance to asedebart or its excipients.\n* The participant has taken any investigational medicinal product (IMP) other than asedebart \\\u003C 3 months or \\\u003C 5 half-lives, whichever is longer, prior to the first dose of asedebart in this trial.\n* The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.\n* The participant has an increased risk of adrenal crisis in the opinion of the investigator (for example history of repeated adrenal crisis in recent years, history of adrenal crisis caused by reduction of GC dose).\n\nOther protocol-defined criteria apply.","ALL","18 Years","70 Years",{"count":81,"type":82},45,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The main goal of the trial is to study the long-term safety, how well people can handle the treatment, and how asedebart acts in the body and affects the body when used to treat classic congenital adrenal hyperplasia (CAH). The trial will include participants who have previously received asedebart in trial 19873A (NCT05669950).",[88],"Adrenal Hyperplasia, Congenital",[90,91,58],"CAH","asedebart","NOT_YET_RECRUITING","2026-09-29",{"date":95,"type":96},"2026-10-05","ACTUAL",{"date":98,"type":82},"2026-10-01",{"date":100,"type":82},"2031-07-31",{"name":5,"class":6}]