NCT07536269 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old
| NCT ID | NCT07536269 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Neurocrine Switzerland GmbH |
| Condition | Congenital Adrenal Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-07-01 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \<4 years of age with CAH.
Eligibility Criteria
Key Inclusion Criteria: * Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD) * Have received at least 3 months of hydrocortisone treatment before Day 1, with a stable dose for at least 4 weeks before screening. * Have a body weight of at least 4.5 kilograms (kg) at screening. * Have a newborn screen that is otherwise normal except for elevated 17-OHP or any other abnormality on newborn screen that was cleared upon evaluation by a pediatric specialist. Key Exclusion Criteria: * Have a known or suspected diagnosis of any of the other forms of classic CAH. * Have any condition besides CAH that requires chronic daily therapy with orally administered steroids. * Have any other clinically significant medical condition or chronic disease. Note: Other protocol-defined inclusion and exclusion criteria may apply.
Contact & Investigator
Clinical Development Lead
STUDY DIRECTOR
Neurocrine Biosciences
Frequently Asked Questions
Who can join the NCT07536269 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 47 Months, studying Congenital Adrenal Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07536269 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07536269 currently recruiting?
Yes, NCT07536269 is actively recruiting participants. Contact the research team at medinfo@neurocrine.com for enrollment information.
Where is the NCT07536269 trial being conducted?
This trial is being conducted at San Francisco, United States, Aurora, United States, Hartford, United States, Atlanta, United States and 7 additional locations.
Who is sponsoring the NCT07536269 clinical trial?
NCT07536269 is sponsored by Neurocrine Switzerland GmbH. The principal investigator is Clinical Development Lead at Neurocrine Biosciences. The trial plans to enroll 20 participants.