A Phase 2 Study to Evaluate the Safety, PK, and Exploratory PD of Tildacerfont in Children With CAH

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

An investigation of the safety of Tildacerfont in pediatric subjects with CAH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spruce Biosciences

Criteria

Inclusion Criteria:

• Male and female subjects aged 6 to 17 years

• Diagnosis of CAH due to 21-OHD and/or elevated 17-OHP requiring ongoing GC replacement since diagnosis

• Stable dose of GC replacement for at least 1 month prior to screening

Exclusion Criteria:

• CAH not due to 21-OHD

• History of bilateral adrenalectomy or hypopituitarism

• Current treatment with dexamethasone

• Clinically significant unstable medical conditions, illness, or chronic diseases

• History of active bleeding disorders

• Females who are pregnant or nursing