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Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

StatusActive, Not Recruiting
PhasePhase 3
Started2021-06-25
View on ClinicalTrials.gov ↗

Amendment history

2025-01-10
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v15
Results first postednot stated→2025-02-05
Eligibility criteria+12 characters
[...] he follow-up visit. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency CAH. Be on a stable steroid regimen of steroidal treatment for CAH. Have elevated androgen levels. Participants of childbearin [...] ry of clinically significant arrhythmia or abnormalities on electrocardiogram (ECG). Have a known hypersensitivity to any corticotropin-releasi [...]
Secondary endpoints7 to 6 entries
Change fromFrom Baseline in Serum 17-hydroxyprogesterone (17-OHP) at Week 4 Percent Change fromFrom Baseline in Glucocorticoid Daily Dose at Week 28 AchievementNumber of Participants Who Achieved a reduction in glucocorticoid daily doseReduction to physiologicPhysiologic levelsGlucocorticoid Dose While Maintaining Androstenedione Control at Week 28 Change fromFrom baselineBaseline in bodyBody massMass indexIndex (BMI) Standard Deviation Score (SDS) at Week 28 Change fromFrom baselineBaseline in salivaryMean 24-hour Salivary 17-OHP at Week 28 Change From Baseline in bonethe ageRatio advancement [...]
Primary endpoints1 entry, revised
Change fromFrom Baseline in Serum Androstenedione (A4) at Week 4
Study title+4 characters
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric PatientsParticipants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
2024-05-03
Study Status v14
Start date2021-06-24→2021-06-25
2024-03-05
Study Status v13
Re-verified, no change to tracked fields
2023-04-11
Study Status v12
Primary completion dateestimated 2023-08→confirmed 2023-03-10
2023-02-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 81→confirmed 103
Study sitesdetails revised at 46 of 46 sites
Show 10 earlier versions
2022-12-09
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v10
Primary completion date2023-04→2023-08
Completion date2024-04→2027-08
Study sites41→46
InterventionsCrinecerfont (Drug), Crinecerfont (Drug), Placebo (Drug)→Crinecerfont (Drug), Placebo (Drug)
Eligibility criteria+4 characters
[...] steroidal treatment for CAH. Have elevated androgen levels. PatientsParticipants of childbearing potential must be abstinent or agree to use [...]
2022-08-30
Study Status, Contacts/Locations v9
Study sites36→41
2022-06-27
Study Status, Contacts/Locations v8
Study sites27→36
2022-04-07
Study Status, Contacts/Locations v7
Study sites25→27
2022-03-08
Study Status, Contacts/Locations v6
Study sites20→25
2022-01-12
Study Status, Contacts/Locations v5
Study sites18→20
2021-12-03
Study Status, Contacts/Locations v4
Study sites15→18
2021-10-28
Study Status, Contacts/Locations v3
Study sites13→15
2021-10-01
Study Status, Contacts/Locations v2
Study sites10→13
2021-09-08
Study Status, Contacts/Locations, References v1
Start dateestimated 2021-03→confirmed 2021-06-24
Study sites1→10
2021-03-16
Original filing
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).
Trial Details
NCT Number NCT04806451
Lead Sponsor Neurocrine Biosciences
Conditions Congenital Adrenal Hyperplasia
Enrollment 103 participants
Start Date 2021-06-25
Primary Completion 2023-03-10 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2025-02-05