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Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia
EU CTIS ID: 2023-509170-33-00
What this study is testing
To evaluate the efficacy of crinecerfont, compared with placebo, in reducing adrenal steroid levels during a glucocorticoid-stable period.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit.
- Be a female or male 2 to 17 years of age with a body weight of at least 10 kg.
- Have a medically confirmed diagnosis of classic CAH due to 21- hydroxylase deficiency.
- Be on a stable regimen of glucocorticoid treatment for CAH.
- Have elevated adrenal androgens.
- If treated with fludrocortisone, dose should be stable for at least 1 month prior to screening. Regardless of fludrocortisone treatment, upright plasma renin activity (PRA) (in the absence of medications that confound interpretation of PRA) during screening should be <3× ULN and >lower limit of normal (LLN) on the subject's usual sodium intake (if PRA >2 × ULN and <3 × ULN, subjects must have normal age-specific systolic blood pressure and heart rate and serum potassium
You likely can't join if
- Have a diagnosis of any of the other forms of classic CAH.
- Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic daily therapy with oral glucocorticoids.
- Have a clinically significant unstable medical condition or chronic disease other than CAH
- Have a history of malignancy, unless successfully treated with curative intent and considered to be cured.
- Have a known history of clinically significant arrhythmia or abnormalities on screening ECG.
- Have a known hypersensitivity or allergy to any corticotropin-releasing hormone (CRH) receptor antagonist or any component of the study drug.
See the full eligibility criteria
- Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit.
- Be a female or male 2 to 17 years of age with a body weight of at least 10 kg.
- Have a medically confirmed diagnosis of classic CAH due to 21- hydroxylase deficiency.
- Be on a stable regimen of glucocorticoid treatment for CAH.
- Have elevated adrenal androgens.
- If treated with fludrocortisone, dose should be stable for at least 1 month prior to screening. Regardless of fludrocortisone treatment, upright plasma renin activity (PRA) (in the absence of medications that confound interpretation of PRA) during screening should be <3× ULN and >lower limit of normal (LLN) on the subject's usual sodium intake (if PRA >2 × ULN and <3 × ULN, subjects must have normal age-specific systolic blood pressure and heart rate and serum potassium
- Have a diagnosis of any of the other forms of classic CAH.
- Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic daily therapy with oral glucocorticoids.
- Have a clinically significant unstable medical condition or chronic disease other than CAH
- Have a history of malignancy, unless successfully treated with curative intent and considered to be cured.
- Have a known history of clinically significant arrhythmia or abnormalities on screening ECG.
- Have a known hypersensitivity or allergy to any corticotropin-releasing hormone (CRH) receptor antagonist or any component of the study drug.
- Females who are pregnant or lactating.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.