Summary

Eligibility
for people ages 3 months to 47 months (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

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.

Official Title

A Phase 2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Crinecerfont in Pediatric Participants 3 Months to <4 Years of Age With Classic Congenital Adrenal Hyperplasia

Keywords

Congenital Adrenal Hyperplasia, CAH, Crinecerfont, Pediatric

Eligibility

You can join if…

Open to people ages 3 months to 47 months

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Neurocrine Clinical Site accepting new patients
    San Francisco California 94143 United States
  • Neurocrine Clinical Site accepting new patients
    Seattle Washington 98101 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurocrine Switzerland GmbH
ID
NCT07536269
Phase
Phase 2 Congenital Adrenal Hyperplasia Research Study
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated