[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634175":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":19,"responsibleParty":30,"collaborators":19,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":19,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":19,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":54,"whyStopped":19,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":19},{"fullName":5,"class":6},"Neurocrine Biosciences","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Crinecerfont","EXPERIMENTAL","Participants with CAH will receive crinecerfont.",[13],"Drug: Crinecerfont",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Oral solution",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Clinical Development Lead","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Neurocrine Medical Information Call Center","CONTACT","1-877-641-3461","medinfo@neurocrine.com",{"type":31,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100634175","phase-2-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-crinecerfont-in-participants-with-classic-congenital-adrenal-hyperplasia-cah-who-are-less-than-4-years-old-100634175",false,"NCT07536269","Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old","A Phase 2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Crinecerfont in Pediatric Participants 3 Months to \u003C4 Years of Age With Classic Congenital Adrenal Hyperplasia","Key Inclusion Criteria:\n\n* Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD)\n* Have received at least 3 months of hydrocortisone treatment before Day 1, with a stable dose for at least 4 weeks before screening.\n* Have a body weight of at least 4.5 kilograms (kg) at screening.\n* Have a newborn screen that is otherwise normal except for elevated 17-OHP or any other abnormality on newborn screen that was cleared upon evaluation by a pediatric specialist.\n\nKey Exclusion Criteria:\n\n* Have a known or suspected diagnosis of any of the other forms of classic CAH.\n* Have any condition besides CAH that requires chronic daily therapy with orally administered steroids.\n* Have any other clinically significant medical condition or chronic disease.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.","ALL","3 Months","47 Months",{"count":43,"type":44},20,"ESTIMATED","INTERVENTIONAL",[47],"PHASE2","The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \\\u003C4 years of age with CAH.",[50],"Congenital Adrenal Hyperplasia",[50,52,9,53],"CAH","Pediatric","NOT_YET_RECRUITING","2026-04-10",{"date":57,"type":58},"2026-04-17","ACTUAL",{"date":60,"type":44},"2026-04",{"date":62,"type":44},"2028-03",{"name":5,"class":6}]