A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509170-33-00

Acronym

NBI-74788-CAH2006

Enrollment

Registered

2024-05-24

Start date

2021-11-23

Completion date

Unknown

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classic Congenital Adrenal Hyperplasia (CAH)

Brief summary

Change from baseline in serum androstenedione at Week 4.

Detailed description

Change from baseline in serum 17-hydroxyprogesterone at Week 4, Percent change from baseline in glucocorticoid dose at Week 28

Interventions

DRUGCrinecerfont placebo for oral solution

DRUGNBI-74788

DRUGCrinecerfont placebo for oral Capsules

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in serum androstenedione at Week 4.	—

Secondary

Measure	Time frame
Change from baseline in serum 17-hydroxyprogesterone at Week 4, Percent change from baseline in glucocorticoid dose at Week 28	—

Countries

Belgium, France, Germany, Greece, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026