NCT04544410

A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Spruce Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An investigation of the ability of Tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic Congenital adrenal hyperplasia (CAH) subjects up to 76 weeks of treatment. Optional open label extension up to 240 weeks.

Detailed description

This is a study that evaluated the ability of tildacerfont to reduce the glucocorticoid steroid dose used by adult subjects with CAH. The first 24-weeks were a double-blind, placebo controlled, comparison of tildacerfont vs placebo. The following 52-weeks allowed all subjects to move to open label tildacerfont to continue to reduce steroid dose where appropriate, and observe long term safety. Subjects were offered a long term open label extension up to 240 weeks.

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Tildacerfont/Placebo	Tablet, administered daily

Timeline

• Start date: 2021-02-22
• Primary completion: 2024-10-31
• Completion: 2025-01-31
• First posted: 2020-09-10
• Last updated: 2025-10-01
• Results posted: 2025-10-01

Locations

43 sites across 16 countries: United States, Australia, Brazil, Canada, Estonia, Germany, Italy, Latvia, Lithuania, Poland, Romania, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study