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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 3 Months and 47 Months
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Crinecerfont 		Participants with CAH will receive crinecerfont.
  • Drug: Crinecerfont
    Oral solution

Recruiting Locations

Neurocrine Clinical Site
San Francisco, California 94143

Neurocrine Clinical Site
Hartford, Connecticut 06106

Neurocrine Clinical Site
Atlanta, Georgia 30329

Neurocrine Clinical Site
Chicago, Illinois 60618

Neurocrine Clinical Site
Indianapolis, Indiana 46202

Neurocrine Clinical Site
Ann Arbor, Michigan 48109

Neurocrine Clinical Site
Minneapolis, Minnesota 55454

Neurocrine Clinical Site
Philadelphia, Pennsylvania 19104

Neurocrine Clinical Site
Dallas, Texas 75235

Neurocrine Clinical Site
Seattle, Washington 98101

More Details

Status
Recruiting
Sponsor
Neurocrine Switzerland GmbH

Study Contact

Neurocrine Medical Information Call Center
1-877-641-3461
medinfo@neurocrine.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.