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 <4 Years of Age With Classic Congenital Adrenal Hyperplasia

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 3 Months – 47 Months
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \<4 years of age with CAH.

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Crinecerfont	Oral solution

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Regulatory

• FDA-regulated drug study