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Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

NCT04806451 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-02-05

Study results available
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Summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 28 weeks in approximately 81 pediatric participants with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency. The study consists of a 28-week double blind, placebo-controlled period, followed by 24 weeks of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 14 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).

Conditions

  • Congenital Adrenal Hyperplasia

Interventions

DRUG

Crinecerfont

CRF type 1 receptor antagonist

DRUG

Placebo

Non-active dosage form

Sponsors & Collaborators

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Clinical Development Lead · Neurocrine Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-25
Primary Completion
2023-03-10
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04806451 on ClinicalTrials.gov