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Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

Study acronym: CAHtalyst
StatusActive, Not Recruiting
PhasePhase 3
Started2020-12-16
View on ClinicalTrials.gov ↗

Amendment history

2026-04-20
Study Status v22
Re-verified, no change to tracked fields
2025-01-10
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, References, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v21
Start date2020-11-16→2020-12-16
Results first postednot stated→2025-02-05
Eligibility criteria-7 characters
[...] w-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. Participants of childbearing potential must agree to use a [...] own hypersensitivity to any corticotropin releasing hormone receptor antagonists. Have received any other investigational drug wi [...]
Secondary endpoints10 to 11 entries
Change fromFrom baselineBaseline in serumSerum androstenedioneAndrostenedione at Week 4 AchievementNumber of Participants Who Achieved a reduction in glucocorticoid daily doseReduction to physiologicPhysiologic levelsGlucocorticoid Dose While Maintaining Androstenedione Control at Week 24 Change fromFrom baselineBaseline in homeostaticHomeostatic modelModel assessmentAssessment of insulinInsulin resistanceResistance (HOMA-IR) indexat Week 24 Percent Change From Baseline in Body Weight at Week 24 Change fromFrom baselineBaseline in bodyPercent weightTotal Fat Mass at Week 24 Change fromFrom bas [...] [...]
Primary endpoints1 entry, revised
Percent changeChange fromFrom baselineBaseline in glucocorticoidGlucocorticoid dailyDaily doseDose at Week 24
2024-07-11
Study Status v20
Re-verified, no change to tracked fields
2024-05-03
Study Status v19
Start date2020-07-23→2020-11-16
2023-08-17
Study Status v18
Primary completion dateestimated 2023-08→confirmed 2023-07-19
Show 17 earlier versions
2023-02-10
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 165→confirmed 182
Study sites73→70
2022-12-09
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v16
Primary completion date2023-02→2023-08
Completion date2024-02→2027-08
Study sites69→73
Eligibility criteria-70 characters
[...] CAH. Be on a stable regimen of steroidal treatment for CAH. PatientsParticipants of childbearing potential must agree to use hormonalan oracceptable two formsmethod of nonhormonal contraception (dual contraception) or other highly effective contraception during the study. Exclusion Criteria: Have a [...]
Secondary endpoints10 entries, revised
Change from baseline in testicular adrenal rest tumor size at Week 24
2022-09-14
Study Status, Contacts/Locations v15
Study sites68→69
2022-08-30
Study Status, Contacts/Locations, References v14
Study sites63→68
2022-04-07
Study Status, Contacts/Locations v13
Study sitesdetails revised at 9 of 63 sites
2022-03-08
Study Status, Contacts/Locations v12
Study sites60→63
2022-01-12
Study Status, Contacts/Locations v11
Study sites56→60
2021-12-03
Study Status, Contacts/Locations v10
Study sites55→56
2021-10-28
Study Status, Contacts/Locations v9
Study sites47→55
2021-08-04
Study Status, Contacts/Locations v8
Re-verified, no change to tracked fields
2021-07-12
Study Status, Contacts/Locations v7
Study sites36→47
2021-05-10
Study Status, Contacts/Locations v6
Study sites25→36
2021-04-01
Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations v5
Study sites15→25
Secondary endpoints5 to 10 entries
Change from baseline in blood pressure at Week 24 Change from baseline in glucose tolerance at Week 24 Change from baseline in waist circumference at Week 24 Change from baseline in menstrual regularity at Week 24 Change from baseline in testicular adrenal rest tumor at Week 24
2021-01-28
Study Status, Contacts/Locations v4
Study sites12→15
2020-12-29
Study Status, Contacts/Locations v3
Study sites4→12
2020-12-02
Study Status, Contacts/Locations v2
Study sites1→4
2020-07-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-07→confirmed 2020-07-23
Study sites0→1
2020-07-24
Original filing
This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active 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 20 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 NCT04490915
Lead Sponsor Neurocrine Biosciences
Conditions Congenital Adrenal Hyperplasia
Enrollment 182 participants
Start Date 2020-12-16
Primary Completion 2023-07-19 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-05-11