A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519579-24-00

Acronym

CRN04894-12

Enrollment

Registered

2025-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Classic Congenital Adrenal Hyperplasia

Brief summary

Proportion of participants with morning post-GC A4 ≤ULN who are on physiologic GC replacement at Week 32

Detailed description

Percent change from baseline of morning A4 at Week 2 Percent change from baseline of morning 17-OHP at Week 32  Proportion of participants with morning pre-GC A4 ≤ULN who are on physiologic GC replacement at Week 32  Percent change from baseline in GC daily dose when morning post-GC A4 ≤ULN at week 32

Interventions

DRUGAtumelnant 80 mg tablets

DRUGTablet

DRUGAtumelnant 120 mg tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants with morning post-GC A4 ≤ULN who are on physiologic GC replacement at Week 32	—

Secondary

Measure	Time frame
Percent change from baseline of morning A4 at Week 2 Percent change from baseline of morning 17-OHP at Week 32  Proportion of participants with morning pre-GC A4 ≤ULN who are on physiologic GC replacement at Week 32  Percent change from baseline in GC daily dose when morning post-GC A4 ≤ULN at week 32	—

Countries

Austria, France, Germany, Italy, Netherlands, Poland, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026