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NCT04806451 · ClinicalTrials.gov registry record · Phase 3
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
A Phase 3 study of Congenital Adrenal Hyperplasia, sponsored by Neurocrine Biosciences.
- Active
- Registry status
- Phase 3
- Development phase
- 103
- Enrollment target
- 20
- Study locations
NCT04806451: Active Phase 3 study of Congenital Adrenal Hyperplasia, sponsored by Neurocrine Biosciences.
NCT04806451 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 103 participants, above the 90-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04806451, 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
- 103 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 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks 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 14 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
Blood serum samples were collected for the analysis of serum androstenedione concentrations. 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 - Orange
- Neurocrine Clinical Site - San Diego
- Neurocrine Clinical Site - San Francisco
New York
- Neurocrine Clinical Site - New Hyde Park
- Neurocrine Clinical Site - New York
Oklahoma
- Neurocrine Clinical Site - Oklahoma City
- Neurocrine Clinical Site - Tulsa
Pennsylvania
- Neurocrine Clinical Site - Philadelphia
- Neurocrine Clinical Site - Pittsburgh
Alabama
- Neurocrine Clinical Site - Birmingham
Colorado
- Neurocrine Clinical Site - Aurora
Connecticut
- Neurocrine Clinical Site - Hartford
District of Columbia
- Neurocrine Clinical Site - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2021-06-25 |
| Est. Completion | 2027-08 |
| Phase | Phase 3 |
What the registry record for NCT04806451 still lists
NCT04806451 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, above the 90-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (14% 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.
NCT04806451 names 20 study sites across 14 states, led by California, New York, Oklahoma.
Frequently Asked Questions
What is clinical trial NCT04806451 about?
NCT04806451 is a clinical study titled "Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)". This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double bl...
What is the current status of trial NCT04806451?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2021-06-25. Estimated completion is 2027-08.
What conditions does trial NCT04806451 study?
This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia.
What interventions are being tested in trial NCT04806451?
The interventions under investigation include: Placebo (DRUG), Crinecerfont (DRUG).
Who is sponsoring clinical trial NCT04806451?
This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04806451 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04806451's enrollment target sits among peer trials
103 5th of 8 higher than 4 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
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