Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
Public ClinicalTrials.gov record NCT04806451. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04806451
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2021 (Actual)
- Primary completion
- Mar 10, 2023 (Actual)
- Completion
- Aug 2027 (Estimated)
- Last update posted
- Feb 5, 2025
2021 – 2027
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neurocrine Clinical Site | Birmingham | Alabama | 35233 | — |
| Neurocrine Clinical Site | Los Angeles | California | 90027 | — |
| Neurocrine Clinical Site | Orange | California | 92868 | — |
| Neurocrine Clinical Site | San Diego | California | 92123 | — |
| Neurocrine Clinical Site | San Francisco | California | 94158 | — |
| Neurocrine Clinical Site | Aurora | Colorado | 80045 | — |
| Neurocrine Clinical Site | Hartford | Connecticut | 06106 | — |
| Neurocrine Clinical Site | Washington D.C. | District of Columbia | 20010 | — |
| Neurocrine Clinical Site | Atlanta | Georgia | 30329 | — |
| Neurocrine Clinical Site | Indianapolis | Indiana | 46202 | — |
| Neurocrine Clinical Site | Boston | Massachusetts | 02115 | — |
| Neurocrine Clinical Site | Ann Arbor | Michigan | 48109 | — |
| Neurocrine Clinical Site | Minneapolis | Minnesota | 55454 | — |
| Neurocrine Clinical site | St Louis | Missouri | 63104 | — |
| Neurocrine Clinical Site | New Hyde Park | New York | 11040 | — |
| Neurocrine Clinical Site | New York | New York | 10065 | — |
| Neurocrine Clinical Site | Oklahoma City | Oklahoma | 73104 | — |
| Neurocrine Clinical Site | Tulsa | Oklahoma | 74135 | — |
| Neurocrine Clinical Site | Philadelphia | Pennsylvania | 19104 | — |
| Neurocrine Clinical Site | Pittsburgh | Pennsylvania | 15224 | — |
| Neurocrine Clinical Site | Dallas | Texas | 75235 | — |
| Neurocrine Clinical Site | Seattle | Washington | 98105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04806451, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 5, 2025 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04806451 live on ClinicalTrials.gov.