A phase II, multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516825-30-00

Acronym

CLCI699C2203

Enrollment

Registered

2024-10-31

Start date

2020-09-21

Completion date

2025-10-13

Last updated

2025-03-17

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

Conditions

Cushing's disease

Brief summary

Pharmacokinetic parameters of osilodrostat

Detailed description

Proportion of patients with normal mUFC, mUFC absolute values and change from baseline, Safety and tolerability

Interventions

DRUGIsturisa 1 mg film-coated tablets

DRUGIsturisa 5 mg film-coated tablets

DRUGIsturisa 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters of osilodrostat	—

Secondary

Measure	Time frame
Proportion of patients with normal mUFC, mUFC absolute values and change from baseline, Safety and tolerability	—

Countries

Belgium, France, Italy

Outcome results

None listed

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