Clinical Trials Logo
  1. Home
  2. Congenital Adrenal Hyperplasia
  3. NCT04544410

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

Congenital Adrenal Hyperplasia Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial Description

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

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04544410
Study type Interventional
Source Spruce Biosciences
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 29, 2020
Completion date September 2029
View Details
See also
  Status Clinical Trial Phase
Completed NCT03687242 - Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia Phase 2
Not yet recruiting NCT04087148 - Linear Growth of Children With Congenital Adrenal Hyperplasia
Completed NCT03162159 - Adult Height Prediction in Congenital Adrenal Hyperplasia
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Enrolling by invitation NCT05162950 - Effects and Importance of Epinephrine/Adrenalin Deficiency in CAH
Withdrawn NCT03532022 - Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy Phase 3
Recruiting NCT02795871 - Prenatal Dex Study N/A
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Recruiting NCT04903587 - Gonadal Changes In Congenital Adrenal Hyperplasia Patients
Not yet recruiting NCT04536662 - Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency Phase 4
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Completed NCT01807364 - Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia N/A
Completed NCT02804178 - A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia Phase 2
Completed NCT03019614 - An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone Phase 1
Not yet recruiting NCT04293133 - Final Height in Patients With CAH
Recruiting NCT03897504 - Surgical Evaluation of Using the Prepuce in Feminizing Genitoplasty N/A
Active, not recruiting NCT04806451 - Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study) Phase 3
Completed NCT01875640 - Decision Support for Parents Receiving Information About Child's Rare Disease N/A
Withdrawn NCT00485186 - Gene Polymorphisms Influencing Steroid Synthesis and Action N/A
Recruiting NCT04890444 - China Adrenal Disease Registry