A 12-Week, Phase 2 Open-Label, Sequential Dose Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 Treatment in Participants with Congenital Adrenal Hyperplasia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503488-40-00

Acronym

CRN04894-03

Enrollment

Registered

2023-09-26

Start date

2023-11-27

Completion date

2024-11-07

Last updated

2024-10-24

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

Conditions

CONGENITAL ADRENAL HYPERPLASIA

Brief summary

Primary Safety Endpoints: Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs) and any adverse events (AEs) leading to discontinuation, Primary Efficacy Endpoint: Change from Baseline in morning (before 11:00) serum A4 at Week 12

Detailed description

Secondary Efficacy Endpoint: Change from Baseline in morning (before 11:00) serum 17-OHP at Week 12

Interventions

DRUGMETHYLPREDNISOLONE

DRUGPREDNISOLONE

DRUGFLUDROCORTISONE

DRUGHYDROCORTISONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Primary Safety Endpoints: Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs) and any adverse events (AEs) leading to discontinuation, Primary Efficacy Endpoint: Change from Baseline in morning (before 11:00) serum A4 at Week 12	—

Secondary

Measure	Time frame
Secondary Efficacy Endpoint: Change from Baseline in morning (before 11:00) serum 17-OHP at Week 12	—

Countries

Germany, Italy

Outcome results

None listed

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