Status:
ACTIVE_NOT_RECRUITING
Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Congenital Adrenal Hyperplasia
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- Be willing and able to adhere to the study procedures, including all requirements at the study center, and return for the follow-up visit.
- Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency.
- Be on a stable steroid regimen.
- Have elevated androgen levels.
- Participants of childbearing potential must be abstinent or agree to use appropriate birth control during the study.
Exclusion
- Have a diagnosis of any of the other forms of classic CAH.
- Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
- Have a clinically significant unstable medical condition or chronic disease other than CAH.
- Have a history of cancer unless considered to be cured.
- Have a known history of clinically significant arrhythmia or abnormalities on electrocardiogram (ECG).
- Have a known hypersensitivity to any corticotropin-releasing hormone antagonist.
- Have received an investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
- Have current substance dependence or substance (drug) or alcohol abuse.
- Have had a significant blood loss or donated blood or blood products within 8 weeks prior to the study.
Key Trial Info
Start Date :
June 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04806451
Start Date
June 25 2021
End Date
August 1 2027
Last Update
February 5 2025
Active Locations (46)
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1
Neurocrine Clinical Site
Birmingham, Alabama, United States, 35233
2
Neurocrine Clinical Site
Los Angeles, California, United States, 90027
3
Neurocrine Clinical Site
Orange, California, United States, 92868
4
Neurocrine Clinical Site
San Diego, California, United States, 92123