A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH

  • STATUS
    Recruiting
  • End date
    Sep 19, 2025
  • participants needed
    90
  • sponsor
    Spruce Biosciences
Updated on 7 October 2022
Investigator
Clinical Trials
Primary Contact
Spruce Study Site (7.2 mi away) Contact
+54 other location
prednisone
deficiency
prednisolone
21-ohd

Summary

An investigation of the ability of Tildacerfont to reduce supraphysiologic glucocorticoid dosing in classic CAH subjects up to 76 weeks of treatment. Optional open label extension up to 240 weeks.

Description

This is a study that will evaluate the ability of Tildacerfont to reduce the glucocorticoid steroid dose used by adult CAH subjects. The first 24-weeks will be a double-blind, placebo controlled, comparison of Tildacerfont vs Placebo. The following 52-weeks will allow all subjects to move to open label Tildacerfont to continue to reduce steroid dose where appropriate, and observe long term safety. Subjects will be offered a long term open label extension up to 240 weeks.

Details
Condition Congenital Adrenal Hyperplasia
Treatment Tildacerfont/Placebo
Clinical Study IdentifierNCT04544410
SponsorSpruce Biosciences
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female subjects over 18 years old, inclusive
Has a documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or documented elevated 17-OHP and currently treatment with HC, HC acetate, prednisone, prednisolone, methylprednisolone (or a combination of the aforementioned GCs)
Has been on a stable, supraphysiologic dose of GC replacement for ≥1 month before screening
For subjects with the salt-wasting form of CAH, subject has been on a stable dose of mineralocorticoid replacement for ≥1 month before screening

Exclusion Criteria

Has a known or suspected diagnosis of any other known form of classic CAH (not due to 21-hydroxylase deficiency)
Has a history that includes bilateral adrenalectomy or hypopituitarism
Has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other CRF1 receptor antagonist
Shows clinical signs or symptoms of adrenal insufficiency
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