Status:
ACTIVE_NOT_RECRUITING
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Congenital Adrenal Hyperplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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-h...
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.
- Participants of childbearing potential must agree to use an acceptable method of contraception during the study.
Exclusion
- Have a diagnosis of any of the other known 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 cured.
- Are pregnant.
- Have a known history of clinically significant arrhythmia or abnormalities on ECG.
- Have a known hypersensitivity to any corticotropin releasing hormone receptor antagonists.
- Have received any other 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 current substance (drug) or alcohol abuse.
- Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2027
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT04490915
Start Date
December 16 2020
End Date
August 1 2027
Last Update
February 5 2025
Active Locations (70)
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1
Neurocrine Clinical Site
Los Angeles, California, United States, 90027
2
Neurocrine Clinical Site
San Diego, California, United States, 92123
3
Neurocrine Clinical Site
San Francisco, California, United States, 94143
4
Neurocrine Clinical Site
Aurora, Colorado, United States, 80045