Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

  • STATUS
    Recruiting
  • participants needed
    165
  • sponsor
    Neurocrine Biosciences
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Updated on 19 February 2024
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deficiency
adrenaline
congenital adrenal hypoplasia

Summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult subjects with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6 month randomized, double blind, placebo-controlled period, followed by 1 year of treatment with crinecerfont. Duration of participation is approximately 20 months.

Details
Condition Congenital adrenal hyperplasia, Congenital adrenal hyperplasia
Age 18years - 100years
Treatment Placebo, Crinecerfont
Clinical Study IdentifierNCT04490915
SponsorNeurocrine Biosciences
Last Modified on19 February 2024

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 classic 21-hydroxylase deficiency CAH
Be on a stable regimen of steroidal treatment for CAH
Patients of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) or other highly effective contraception during the study

Exclusion Criteria

Have a diagnosis of any of the other known 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 cured
Are pregnant
Have a known history of clinically significant arrhythmia or abnormalities on ECG
Have a known hypersensitivity to any corticotropin releasing hormone antagonists
Have received any other 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 current substance (drug) or alcohol abuse
Have had a blood loss 550 mL 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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