clinical trial · NCT05128942
A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH
Congenital Adrenal Hyperplasia21-OHDTildacerfont
brief summary
An investigation of the safety and efficacy of tildacerfont in participants with CAH.
started
Dec 10, 2021
primary completion
Jan 31, 2025
completion
Jan 31, 2025
last updated
Dec 24, 2025
detailed description
This is a Phase 2 open-label study with up to 10 cohorts that will evaluate the safety, efficacy, and PK of different tildacerfont dosing regimens potentially up to 200mg QD for 12 weeks in children with classic CAH, and up to 400mg BID for 4 weeks in children and adults with classic CAH.
official title
A Phase 2 Study to Evaluate the Safety, Efficacy and Pharmacokinetics of SPR001 (Tildacerfont) in Children Aged 2 to 17 Years With Congenital Adrenal Hyperplasia (CAH)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol