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 States, Austria, Belgium182 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24
. 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.