A Phase 2 Study to Evaluate the Safety, PK, and Exploratory PD of Tildacerfont in Children With CAH

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    20
  • sponsor
    Spruce Biosciences
Updated on 22 July 2022
21-ohd

Summary

An investigation of the safety of Tildacerfont in pediatric subjects with CAH.

Description

This is a study to evaluate the safety of Tildacerfont in pediatric subjects with CAH. Treatment will consist of 14 days of continuous dosing followed by safety follow up.

Details
Condition Congenital Adrenal Hyperplasia, 21-OHD
Treatment Tildacerfont
Clinical Study IdentifierNCT05128942
SponsorSpruce Biosciences
Last Modified on22 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female subjects aged 6 to 17 years
Diagnosis of CAH due to 21-OHD and/or elevated 17-OHP requiring ongoing GC replacement since diagnosis
Stable dose of GC replacement for at least 1 month prior to screening

Exclusion Criteria

CAH not due to 21-OHD
History of bilateral adrenalectomy or hypopituitarism
Current treatment with dexamethasone
Clinically significant unstable medical conditions, illness, or chronic diseases
History of active bleeding disorders
Females who are pregnant or nursing
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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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