NCT04457336

A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Spruce Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen. Optional open label treatment extension period up to 240 weeks with 200mg Tildacerfont QD.

Detailed description

This is a study that will test the efficacy and safety of Tildacerfont. The first 12-weeks will be a double-blind, placebo controlled, dose ranging study. The following 58-weeks will assess the long term safety of Tildacerfont. Optional open label treatment extension period up to 240 weeks with 200mg Tildacerfont QD.

Conditions

• Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	Tildacerfont/Placebo	Tablet, administered daily

Timeline

• Start date: 2020-08-26
• Primary completion: 2024-02-09
• Completion: 2024-05-23
• First posted: 2020-07-07
• Last updated: 2025-07-08
• Results posted: 2025-07-08

Locations

65 sites across 20 countries: United States, Australia, Brazil, Canada, Denmark, Estonia, Germany, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study