Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
Condition(s) studied
Investigational drug(s) / intervention(s)
Crinecerfont: CRF type 1 receptor antagonist
Placebo: Non-active dosage form
Study 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 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active 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 participant for the OLE (estimated to be approximately 3 years).
Eligibility
Primary outcome measure(s)
- Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24 — Baseline, Week 24
Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Trial sites (70)
| Facility | City | Region | Status |
|---|---|---|---|
| Neurocrine Clinical Site | Los Angeles | California | |
| Neurocrine Clinical Site | San Diego | California | |
| Neurocrine Clinical Site | San Francisco | California | |
| Neurocrine Clinical Site | Aurora | Colorado | |
| Neurocrine Clinical Site | Atlanta | Georgia | |
| Neurocrine Clinical Site | Indianapolis | Indiana | |
| Neurocrine Clinical Site | Bethesda | Maryland | |
| Neurocrine Clinical Site | Boston | Massachusetts | |
| Neurocrine Clinical Site | Ann Arbor | Michigan | |
| Neurocrine Clinical Site | Minneapolis | Minnesota | |
| Neurocrine Clinical Site | Rochester | Minnesota | |
| Neurocrine Clinical Site | St Louis | Missouri | |
| Neurocrine Clinical Site | Great Neck | New York | |
| Neurocrine Clinical Site | New York | New York | |
| Neurocrine Clinical Site | Winston-Salem | North Carolina | |
| Neurocrine Clinical Site | Tulsa | Oklahoma | |
| Neurocrine Clinical Site | Philadelphia | Pennsylvania | |
| Neurocrine Clinical Site | Pittsburgh | Pennsylvania | |
| Neurocrine Clinical Site | Dallas | Texas | |
| Neurocrine Clinical Site | Seattle | Washington | |
| Neurocrine Clinical Site | Graz | Austria | |
| Neurocrine Clinical Site | Vienna | Austria | |
| Neurocrine Clinical Site | Brussels | Belgium | |
| Neurocrine Clinical Site | Leuven | Belgium | |
| Neurocrine Clinical Site | Sofia | Bulgaria | |
| Neurocrine Clinical Site | Sofia | Bulgaria | |
| Neurocrine Clinical Site | Halifax | Nova Scotia | |
| Neurocrine Clinical Site | Hradec Králové | Czechia | |
| Neurocrine Clinical Site | Angers | France | |
| Neurocrine Clinical Site | Grenoble | France | |
| Neurocrine Clinical Site | Le Kremlin-Bicêtre | France | |
| Neurocrine Clinical Site | Nantes | France | |
| Neurocrine Clinical Site | Paris | France | |
| Neurocrine Clinical Site | Paris | France | |
| Neurocrine Clinical Site | Dresden | Germany | |
| Neurocrine Clinical Site | Essen | Germany | |
| Neurocrine Clinical Site | Frankfurt | Germany | |
| Neurocrine Clinical Site | Leipzig | Germany | |
| Neurocrine Clinical Site | Munich | Germany | |
| Neurocrine Clinical Site | Athens | Greece |
+ 30 more sites — see the full list on the official registry below.
More Neurocrine Biosciences trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04490915 on ClinicalTrials.gov ↗ ← All trials in Belgium