Classic congenital adrenal hyperplasia
Conditions
Brief summary
Part A: -Incidence of TEAEs including treatment emergent SAEs and any Aes leading to discontinuation. -Change from baseline in morning A4 at Week 8 Part B: -Percent change from baseline in GC daily dose at Week 28 while serum early morning A4≤ULN Part C: -Change from baseline in morning A4 over time
Detailed description
Part A: -Change from baseline in morning serum 17-OHP at Week 8 -Plasma and blood concentrations of atumelnant, Part B: -Change from baseline in morning A4 at Week 4 -Change from baseline in morning 17 OHP at Week 4 -Proportion of participants with physiologic GC dose while morning A4 , Part C: -Change from baseline in morning 17-OHP over time -Percent change from baseline in GC daily dose over time -Proportion of participants with physiologic GC dose while morning A4
Interventions
Sponsors
Crinetics Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: -Incidence of TEAEs including treatment emergent SAEs and any Aes leading to discontinuation. -Change from baseline in morning A4 at Week 8 Part B: -Percent change from baseline in GC daily dose at Week 28 while serum early morning A4≤ULN Part C: -Change from baseline in morning A4 over time | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: -Change from baseline in morning serum 17-OHP at Week 8 -Plasma and blood concentrations of atumelnant, Part B: -Change from baseline in morning A4 at Week 4 -Change from baseline in morning 17 OHP at Week 4 -Proportion of participants with physiologic GC dose while morning A4 , Part C: -Change from baseline in morning 17-OHP over time -Percent change from baseline in GC daily dose over time -Proportion of participants with physiologic GC dose while morning A4 | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland
Outcome results
None listed