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

Congenital Adrenal Hyperplasia Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04457336
Study type Interventional
Source Spruce Biosciences
Contact
Status Terminated
Phase Phase 2
Start date August 26, 2020
Completion date May 23, 2024
View Details
See also
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