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Tildacerfont in Adult Classic Congenital Adrenal Hyperplasia
NCT04457336Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2020
- Primary completion
- Feb 2024
- Countries
- 20
- Sponsor
- Spruce Biosciences, Inc.
- Modality
- Small Molecules
- Drugs
- tildacerfont
- Conditions
- classic congenital adrenal hyperplasia
01
Overview
Phase 2, randomised, double-blind trial of tildacerfont in classic congenital adrenal hyperplasia (4 arms), sponsored by Spruce Biosciences, Inc. Primary endpoint: Androstenedione at 12 weeks. Started Aug 2020; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Tildacerfont Group 1
Dose level 1 for 12 weeks
Tildacerfont Group 2
Dose level 2 for 12 weeks
Tildacerfont Group 3
Dose level 3 (likely continues into extension)
Placebo
Placebo for 12 weeks
03
Who it enrols
Adults with classic CAH on stable glucocorticoid therapy with elevated androstenedione (A4) or 17-OHP levels.
04
Endpoints
Primary
Androstenedione
Secondary
17-hydroxyprogesterone
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