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

  • STATUS
    Recruiting
  • End date
    Apr 18, 2024
  • participants needed
    81
  • sponsor
    Neurocrine Biosciences
Updated on 7 October 2022
Investigator
Neurocrine Medical Information Call Center
Primary Contact
Neurocrine Clinical Site (8.7 mi away) Contact
+38 other location
deficiency
classic congenital adrenal hyperplasia
21-ohd

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 patients 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 treatment with crinecerfont. Duration of participation is approximately 14 months.

Details
Condition Congenital Adrenal Hyperplasia
Treatment Placebo, Crinecerfont
Clinical Study IdentifierNCT04806451
SponsorNeurocrine Biosciences
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Be willing and able to adhere to the study procedures, including all requirements at the study center, and return for the follow-up visit
Have a medically confirmed diagnosis of 21-hydroxylase deficiency CAH
Be on a stable regimen of steroidal treatment for CAH
Have elevated androgen levels
Patients of childbearing potential must be abstinent or agree to use appropriate birth control during the study

Exclusion Criteria

Have a diagnosis of any of the other forms of classic CAH
Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
Have a clinically significant unstable medical condition or chronic disease other than CAH
Have a history of cancer unless considered to be cured
Have a known history of clinically significant arrhythmia or abnormalities on ECG
Have a known hypersensitivity to any corticotropin-releasing hormone antagonist
Have received an investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study
Have current substance dependence or substance (drug) or alcohol abuse
Have had a significant blood loss or donated blood or blood products within 8 weeks prior to the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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