Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04490915 · ClinicalTrials.gov registry record · Phase 3
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
A Phase 3 study of Congenital Adrenal Hyperplasia, sponsored by Neurocrine Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 182
- Enrollment target
- 20
- Study locations
NCT04490915: Active Phase 3 study of Congenital Adrenal Hyperplasia, sponsored by Neurocrine Biosciences.
NCT04490915 is a Phase 3 study of Congenital Adrenal Hyperplasia that is active but no longer recruiting, run by Neurocrine Biosciences. The registered enrollment target is 182 participants, above the 80-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (127% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04490915, a Phase 3 study of Congenital Adrenal Hyperplasia, is active but no longer recruiting, sponsored by Neurocrine Biosciences.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 182 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Crinecerfont
Study Locations (20)
California
- Neurocrine Clinical Site - Los Angeles
- Neurocrine Clinical Site - San Diego
- Neurocrine Clinical Site - San Francisco
Minnesota
- Neurocrine Clinical Site - Minneapolis
- Neurocrine Clinical Site - Rochester
New York
- Neurocrine Clinical Site - Great Neck
- Neurocrine Clinical Site - New York
Pennsylvania
- Neurocrine Clinical Site - Philadelphia
- Neurocrine Clinical Site - Pittsburgh
Colorado
- Neurocrine Clinical Site - Aurora
Georgia
- Neurocrine Clinical Site - Atlanta
Indiana
- Neurocrine Clinical Site - Indianapolis
Maryland
- Neurocrine Clinical Site - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2027-08 |
| Phase | Phase 3 |
What the registry record for NCT04490915 still lists
NCT04490915 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (127% higher).
The record links to 1 condition, with Congenital Adrenal Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04490915 names 20 study sites across 15 states, led by California, Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT04490915 about?
NCT04490915 is a clinical study titled "Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia". 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 ...
What is the current status of trial NCT04490915?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2020-12-16. Estimated completion is 2027-08.
What conditions does trial NCT04490915 study?
This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia.
What interventions are being tested in trial NCT04490915?
The interventions under investigation include: Placebo (DRUG), Crinecerfont (DRUG).
Who is sponsoring clinical trial NCT04490915?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04490915 being conducted?
This trial has 20 study locations across California, Colorado, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Congenital Adrenal Hyperplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04490915's enrollment target sits among peer trials
182 1st of 8 higher than 8 of 8 other Congenital Adrenal Hyperplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Adrenal Hyperplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
RECRUITING · Phase 3
-
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
ACTIVE NOT RECRUITING · Phase 3
-
A Trial of Lu AG13909 in Participants With Congenital Adrenal Hyperplasia
RECRUITING · Phase 1
-
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
RECRUITING · Phase 2
-
An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894
RECRUITING · Phase 2
-
A Study of Gene Therapy for Classic Congenital Adrenal Hyperplasia (CAH)
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03897998 · 182 participants · Phase 2
Neural Correlates of Hypoalgesia Driven by Observation
- NCT04300556 · 182 participants · Phase 1
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
- NCT04323735 · 182 participants · Phase 2
Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters
- NCT05606731 · 182 participants · NA
Family Intervention to Prevent Childhood Obesity
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI