Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia (NCT04490915) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
United States182 participantsStarted 2020-12-16
Plain-language 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-hydroxylase deficiency. The study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active 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 20 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).
Who can participate
Age range18 Years
SexALL
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Inclusion 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.
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24
. 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.