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NCT04806451 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Congenital Adrenal Hyperplasia, sponsored by Neurocrine Biosciences.

Active
Registry status
Phase 3
Development phase
103
Enrollment target
20
Study locations

NCT04806451 is a Phase 3 study of Congenital Adrenal Hyperplasia that is active but no longer recruiting, run by Neurocrine Biosciences. The registered enrollment target is 103 participants, above the 90-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (14% higher). The trial reports 20 study locations across 14 states.

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The verdict

NCT04806451, a Phase 3 study of Congenital Adrenal Hyperplasia, is active but no longer recruiting, sponsored by Neurocrine Biosciences.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
103 participants
Enrollment target
20
Study locations

Study 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 Studied

Congenital Adrenal Hyperplasia

Interventions

  • DRUG Placebo
  • DRUG Crinecerfont

Study Locations (20)

California

  • Neurocrine Clinical Site - Los Angeles
  • Neurocrine Clinical Site - Orange
  • Neurocrine Clinical Site - San Diego
  • Neurocrine Clinical Site - San Francisco

New York

  • Neurocrine Clinical Site - New Hyde Park
  • Neurocrine Clinical Site - New York

Oklahoma

  • Neurocrine Clinical Site - Oklahoma City
  • Neurocrine Clinical Site - Tulsa

Pennsylvania

  • Neurocrine Clinical Site - Philadelphia
  • Neurocrine Clinical Site - Pittsburgh

Alabama

  • Neurocrine Clinical Site - Birmingham

Colorado

  • Neurocrine Clinical Site - Aurora

Connecticut

  • Neurocrine Clinical Site - Hartford

District of Columbia

  • Neurocrine Clinical Site - Washington D.C.

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2021-06-25
Est. Completion 2027-08
Phase Phase 3

Sponsor

Neurocrine Biosciences

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04806451

The ClinicalTrials.gov registry entry for NCT04806451 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 90-participant average among 8 other Congenital Adrenal Hyperplasia trials with a reported enrollment target (14% higher). The listed sponsor is Neurocrine Biosciences, which has 65 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Congenital Adrenal Hyperplasia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04806451 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, New York, Oklahoma.

Frequently Asked Questions

What is clinical trial NCT04806451 about?

NCT04806451 is a clinical study titled "Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)". 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 bl...

What is the current status of trial NCT04806451?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 103 participants. The study started on 2021-06-25. Estimated completion is 2027-08.

What conditions does trial NCT04806451 study?

This clinical trial studies the following conditions: Congenital Adrenal Hyperplasia.

What interventions are being tested in trial NCT04806451?

The interventions under investigation include: Placebo (DRUG), Crinecerfont (DRUG).

Who is sponsoring clinical trial NCT04806451?

This trial is sponsored by Neurocrine Biosciences, which has 65 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04806451 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.