A Randomized, Double Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoud Use in Adult Subjects with Classic Congenital Adrenal Hyperplaysia
This study enrolls people with Congenital Adrenal Hyperplasia (CAH), a rare condition that changes the body’s ability to create key hormones. To replace these important hormones, people who live with CAH need to take constant doses of steroids, which mimic hormones and help the body function. The purpose of this study is to learn about how safe and effective a non-steroid option is to treat CAH.
You will be in this study for between 38-72 weeks, with several clinic visits within this time. During in-person visits you will meet with the study team, answer questionnaires, and have blood drawn for testing. During the study you will take tildacerfont tablets alongside your steroid regimen, collect at-home saliva samples every week, and keep an electronic diary. Study takes place at the Diabetes and Endocrinology Research Center of WNY 1000 Youngs Rd Suite 105 Williamsville NY 14221.
To evaluate the effect of tildacerfont in reducing glucocorticoid use in subjects with CAH
Adults ages 18-55
Has a diagnosis of Classic Congenital Adrenal Hyperplaysia due to 21-hydroxylase deficiency
You'll have been on a stable daily dose of steroids (glucocorticoids or mineralocorticoid) before starting the trial.
Please contact the study team for additional eligibility criteria.
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the
contact information above or email email@example.com and someone will assist you.
Your information will be shared only with the research study team for recruitment purposes and designated CTSI personnel for project quality
assurance and will remain confidential. Your information will be stored indefinitely. Should you no longer want this information to be provided
in the aforementioned ways, please contact firstname.lastname@example.org.