[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658186":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":19,"interventions":30,"overallOfficials":36,"centralContacts":40,"locations":11,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":11},{"fullName":5,"class":6},"Neurocrine Biosciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline in A4 Level at Week 8",null,"Baseline, Week 8",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE",[20,26],{"label":21,"type":22,"description":23,"interventionNames":24},"Part 1: NBIP-01435","EXPERIMENTAL","Participants will receive NBIP-01435 administered once a week (QW) subcutaneously (SC) for a minimum of 8 weeks.",[25],"Drug: NBIP-01435",{"label":27,"type":22,"description":28,"interventionNames":29},"Part 2: NBIP-01435","Participants will receive NBIP-01435 administered SC for a minimum of 8 weeks.",[25],[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"DRUG","NBIP-01435","NBIP-01435 will be administered per schedule specified in the arm description.",[21,27],[37],{"name":38,"affiliation":5,"role":39},"Clinical Development Lead","STUDY_DIRECTOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Neurocrine Medical Information Call Center","CONTACT","1-877-641-3461","medinfo@neurocrine.com",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100658186","phase-2-efficacy-safety-tolerability-and-pharmacokinetics-of-nbip-01435-in-adult-participants-with-classic-congenital-adrenal-hyperplasia-cah-100658186",false,"NCT07850739","Efficacy, Safety, Tolerability, and Pharmacokinetics of NBIP-01435 in Adult Participants With Classic Congenital Adrenal Hyperplasia (CAH)","A Phase 2, Open-Label Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBIP-01435 in Adults With Classic Congenital Adrenal Hyperplasia","Key Inclusion Criteria:\n\n* Medically confirmed diagnosis of classic 21-hydroxylase deficiency (21-OHD) CAH, based on standard, medically accepted criteria.\n* Stable glucocorticoid (GC) dose regimen for classic CAH for a minimum of 30 days before screening.\n* If treated with fludrocortisone, the dose should be stable for at least 30 days before screening with an upright plasma renin activity (PRA) \\\u003Cupper limit of normal (ULN) on participant's usual sodium intake.\n* Have elevated A4, based on a blood sample collected at screening.\n* Body weight ≥50 kilograms (kg) for males and ≥45 kg for females.\n* Negative pregnancy test at screening visit and Day 1.\n* Participants with ovaries of childbearing potential must agree to use contraception consistently.\n* Unless considered permanently sterile or vasectomized at least 3 months prior to screening with medically confirmed successful procedure, participants with testes must agree to use effective barrier contraception (that is, condom with spermicide \\[cream, spray, foam, gel, suppository, or polymer film\\]) consistently.\n\nKey Exclusion Criteria:\n\n* Pregnant (that is, positive pregnancy test), or lactating, or plan to become pregnant during the study.\n* Had a clinically significant illness within 30 days of screening.\n* Have a known or suspected diagnosis of any of the other known forms of classic CAH.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","ALL","18 Years","65 Years",{"count":59,"type":60},36,"ESTIMATED","INTERVENTIONAL",[63],"PHASE2","The main objective of this study is to evaluate the efficacy of different dose levels of NBIP-01435 on reducing elevated androstenedione (A4) levels in adults with classic CAH.",[66],"Congenital Adrenal Hyperplasia",[68,69,70,33],"Classic congenital adrenal hyperplasia","CAH","Autosomal recessive disorder","NOT_YET_RECRUITING","2026-09-23",{"date":74,"type":75},"2026-09-30","ACTUAL",{"date":77,"type":60},"2026-12-01",{"date":79,"type":60},"2028-05-11",{"name":5,"class":6}]