Spruce Adult Study

IRB
CHLA-21-00155
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia

This is a randomized, double-blind, placebo-controlled study that will evaluate the potential of tildacerfont to reduce GC burden in adult subjects with classic CAH who have LLD ≤ A4 ≤ 2.5x ULN and are on supraphysiologic doses of GC therapy (≥30 mg/day and ≤60 mg/day HCe). This will be the first study of tildacerfont to evaluate GC dose reduction. In addition, this study will characterize clinical outcomes after up to 76 weeks of treatment with tildacerfont. An optional Open-Label Extension Period will provide an open-label treatment with tildacerfont at 200 mg QD for up to 240 weeks.

Study Details
Clinical Trials Government Identifier
NCT04544410
Keywords
SPR001 Tildacerfont, CAH, Congenital Adrenal Hyperplasia, 21-hydroxylase deficiency
Study Type
Randomized
Eligibility
Adults
Does this study also recruit healthy volunteers?
No
Enrollment Status
Open
Coordinator Contact
Norma Martinez
Contact Email
CAH@chla.usc.edu