Pharmacokinetics, Safety and Tolerability of Crinecerfont in Participants With Congenital Adrenal Hyperplasia Who Are Less Than 2 Years Old

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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07187375

Enrollment

Registered

2025-09-23

Start date

2025-09-30

Completion date

2029-10-04

Last updated

2026-08-28

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

Conditions

Congenital Adrenal Hyperplasia

Keywords

Congenital Adrenal Hyperplasia, CAH, Crinecerfont

Brief summary

The main objective for this study is to evaluate the pharmacokinetics (PK) of crinecerfont in pediatric participants 0 to \<2 years of age with congenital adrenal hyperplasia (CAH).

Interventions

DRUGCrinecerfont

Oral solution

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 23 Months

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Be a female or male between 0 to \<2 years of age at screening. * Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD). * Be on a clinically stable regimen of hydrocortisone (and fludrocortisone, if applicable) treatment. Key

Exclusion criteria

* Have a known or suspected diagnosis of any of the other forms of classic CAH. * Have any condition besides CAH that requires chronic daily therapy with orally administered steroids. * Have any other clinically significant medical condition or chronic disease. Note: Other protocol-defined inclusion and

Design outcomes

Primary

Measure	Time frame
Plasma Concentration of Crinecerfont	Days 7 and 15

Secondary

Measure	Time frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Up to Month 37

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026