A Phase 2, Open-Label Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Crinecerfont in Pediatric Subjects 0 to <2 Years of Age With Congenital Adrenal Hyperplasia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514127-42-00

Acronym

NBI-74788-CAH2011

Enrollment

Registered

2025-07-01

Start date

2025-10-16

Completion date

Unknown

Last updated

2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital adrenal hyperplasia (CAH)

Brief summary

Plasma concentrations of crinecerfont at Days 7 and 15

Detailed description

Incidence of treatment-emergent adverse events (TEAEs)

Interventions

DRUGNBI-74788

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of crinecerfont at Days 7 and 15	—

Secondary

Measure	Time frame
Incidence of treatment-emergent adverse events (TEAEs)	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026