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NCT07850739
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBIP-01435 in Adult Participants With Classic Congenital Adrenal Hyperplasia (CAH)
Conditions: Congenital Adrenal Hyperplasia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 36
Sponsor: Neurocrine Biosciences
Summary
The main objective of this study is to evaluate the efficacy of different dose levels of NBIP-01435 on reducing elevated androstenedione (A4) levels in adults with classic CAH.
Eligibility Criteria
Key Inclusion Criteria:
* Medically confirmed diagnosis of classic 21-hydroxylase deficiency (21-OHD) CAH, based on standard, medically accepted criteria.
* Stable glucocorticoid (GC) dose regimen for classic CAH for a minimum of 30 days before screening.
* If treated with fludrocortisone, the dose should be stable for at least 30 days before screening with an upright plasma renin activity (PRA) \
Source: ClinicalTrials.gov (NCT07850739). StuddyBuddy aggregates publicly available trial information.
