A roll-over Study in Patients With Endogenous Cushing's Syndrome

An open-label, multi-center, roll-over study to assess long term safety in patients with endogenous Cushing's syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224109

Enrollment

180

Registered

2018-10-23

Start date

2018-10-24

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Cushing's syndrome

Interventions

investigational material(s) Generic name etc : Osilodrostat phosphate INN of investigational material : Osilodrostat phosphate Therapeutic category code : 249 Other hormone preparations (including ant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Primary inclusion criteria - Patients who have completed a Global Novartis-sponsored study receiving osilodrostat. - Patients who will continue to benefit from treatment with osilodrostat, as judged by the investigator. - Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements. - Willingness and ability to comply with scheduled visits and treatment plans. - Written informed consent obtained prior to enrolling into the roll-over study .

Exclusion criteria

Exclusion criteria: Primary exclusion criteria - Patients who have been permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study. - Patients who are receiving osilodrostat in combination with unapproved or experimental treatments. - Pregnant or nursing (lactating) women.

Design outcomes

Primary

Measure	Time frame
safety Frequency and severity of AEs/SAEs	—

Secondary

Measure	Time frame
efficacy - Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits. - Frequency, severity and summaries of relevant safety assessments.	—

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026