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ACTIVE NOT RECRUITING Phase 3

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

NCT04806451 · View on ClinicalTrials.gov ↗

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).

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

47 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neurocrine Biosciences, which has 47 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04806451 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, New York, Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04806451?

The interventions under investigation include: Placebo (DRUG), Crinecerfont (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04806451?

This trial is sponsored by Neurocrine Biosciences, which has 47 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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