A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia
Ente finanziatore
Spruce Biosciences, Inc.
Aree / Gruppi di ricerca
Partecipanti al progetto
Descrizione del progetto
This is a study with a 3-part treatment period that will evaluate the efficacy and safety of up to 70 weeks of treatment with tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline (A4 >1.5x ULN and ACTH >2x ULN). This study will enroll approximately 72 subjects with classic CAH currently receiving GC therapy into the start of the Treatment Period. The study will enroll subjects at approximately 70 investigative sites globally.