Classic Congenital Adrenal Hyperplasia
Conditions
Brief summary
Absolute change from baseline in glucocorticoid dose in hydrocortisone equivalent(s) at Week 24
Detailed description
1. 1. Proportion of subjects with baseline GC dose ≤ 35mg HCe who achieve GC dose ≤11 mg/m2/day in HCe and A4 ≤ 1.2x baseline or ≤ ULN at Week 24, 2. Proportion of subjects with GC dose ≤11 mg/m2/day in HCe and A4 ≤ 1.2x baseline or A4 ≤ ULN at Week 24, 3. Proportion of subjects with improvement in at least one cardiovascular risk factor at Week 24.
Interventions
DRUGsame as IMP (Tildacerfont) minus the active substance
DRUGPREDNISOLONE
DRUGTildacerfont
DRUGPrednisolon 1 mg JENAPHARM®
DRUGHydrocortisone
Sponsors
Spruce Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in glucocorticoid dose in hydrocortisone equivalent(s) at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 1. Proportion of subjects with baseline GC dose ≤ 35mg HCe who achieve GC dose ≤11 mg/m2/day in HCe and A4 ≤ 1.2x baseline or ≤ ULN at Week 24, 2. Proportion of subjects with GC dose ≤11 mg/m2/day in HCe and A4 ≤ 1.2x baseline or A4 ≤ ULN at Week 24, 3. Proportion of subjects with improvement in at least one cardiovascular risk factor at Week 24. | — |
Countries
Denmark, Estonia, Germany, Ireland, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, Spain, Sweden
Outcome results
None listed