Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04806451 | Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study) | PHASE3 | ACTIVE NOT_RECRUITING | 103 | — | — | Jun 25, 2021 | Aug 1, 2027 | Feb 5, 2025 | 46 | United States, Belgium +8 |
| NCT04490915 | Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia | PHASE3 | ACTIVE NOT_RECRUITING | 182 | — | — | Dec 16, 2020 | Aug 1, 2027 | May 11, 2026 | 70 | United States, Austria +16 |
| NCT07536269 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old | PHASE2 | NOT YET_RECRUITING | 20 | — | — | Apr 1, 2026 | Mar 1, 2028 | Apr 17, 2026 | - | — |
| NCT07187375 | Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old | PHASE2 | RECRUITING | 6 | — | — | Sep 30, 2025 | Oct 4, 2029 | Mar 20, 2026 | 3 | Germany |
Blood serum samples were collected for the analysis of serum androstenedione concentrations. Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
| Arm | Type | Description |
|---|---|---|
| Crinecerfont | EXPERIMENTAL | Crinecerfont solution or capsule, administered orally, twice daily for 28 weeks during the placebo-controlled treatment period, followed by active treatment with crinecerfont for at least 24 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo solution or capsule, administered orally, twice daily for 28 weeks, followed by active treatment with crinecerfont for at least 24 weeks. |
| Name | Type | Description |
|---|---|---|
| Crinecerfont | DRUG | CRF type 1 receptor antagonist |
| Placebo | DRUG | Non-active dosage form |
Inclusion Criteria: * Be willing and able to adhere to the study procedures, including all requirements at the study center, and return for the follow-up visit. * Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency. * Be on a stable steroid regimen. * Have elevated ...