Clinical Trials Logo
  1. Home
  2. Congenital Adrenal Hyperplasia
  3. NCT04490915

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia — CAHtalyst  

Congenital Adrenal Hyperplasia Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Clinical Trial Summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04490915
Study type Interventional
Source Neurocrine Biosciences
Contact
Status Active, not recruiting
Phase Phase 3
Start date November 16, 2020
Completion date August 2027
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
Active, not recruiting NCT04544410 - A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH 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Withdrawn NCT03532022 - Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy Phase 3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
Recruiting NCT05663320 - A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia 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