A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAH

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

An investigation of the efficacy and safety of up to 70 weeks of treatment with Tildacerfont in subjects with classic CAH who have elevated biomarkers at baseline on their current GC regimen.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

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 dose of GC replacement ≥15 mg/day and ≤50 mg/day in HC equivalents

• 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

• Current treatment with dexamethasone as GC therapy for CAH. Prior treatment with dexamethasone is allowed as long as the transition to an alternative GC regimen (eg, HC, prednisone, or prednisolone) has resulted in a stable dose of GC replacement for ≥1 month before screening.

• Shows clinical signs or symptoms of adrenal insufficiency