Recruiting
Phase 2

Crinecerfont

Sponsor:

Neurocrine Switzerland GmbH

Code:

NCT07536269

Conditions

Congenital Adrenal Hyperplasia

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Crinecerfont

Study Details

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.

Conditions

Congenital Adrenal Hyperplasia

Study ID

NCT07536269

Start date

Jul 1, 2026

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Crinecerfont

Participants with CAH will receive crinecerfont.

Interventions

Crinecerfont

Oral solution

Primary outcome measure

  • Number of Participants With Treatment-emergent Adverse Events (TEAE) [ Time Frame: Day 1 up to 28 weeks ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

San Francisco, California, United States, 94143

Neurocrine Clinical Site

Recruiting

Hartford, Connecticut, United States, 06106

Neurocrine Clinical Site

Recruiting

Atlanta, Georgia, United States, 30329

Neurocrine Clinical Site

Recruiting

Chicago, Illinois, United States, 60618

Neurocrine Clinical Site

Recruiting

Indianapolis, Indiana, United States, 46202

Neurocrine Clinical Site

Recruiting

Ann Arbor, Michigan, United States, 48109

Neurocrine Clinical Site

Recruiting

Minneapolis, Minnesota, United States, 55454

Neurocrine Clinical Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Neurocrine Clinical Site

Recruiting

Dallas, Texas, United States, 75235

Neurocrine Clinical Site

Recruiting

Seattle, Washington, United States, 98101

More Information

Sponsor

Neurocrine Switzerland GmbH

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • Congenital Adrenal Hyperplasia
  • CAH
  • Crinecerfont
  • Pediatric

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Neurocrine Switzerland GmbH on 2026-09-09.