Overview

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

Status:
Recruiting

Trial end date:
2022-11-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Spruce Biosciences

Criteria

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 elevated 17-OHP

- Has been on a stable, supraphysiologic dose of GC replacement for ≥1 month before
screening without any evidence of non-adherence to the GC regimen during this period.

- 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