Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study

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 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002840-34-AT

Enrollment

200

Registered

2018-05-22

Start date

2018-08-03

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

Cushing's syndrome MedDRA version: 20.0 Level: PT Classification code 10011652 Term: Cushing's syndrome System Organ Class: 10014698 - Endocrine disorders

Interventions

Product Name: osilodrostat 1mg Product Code: LCI699 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: osilodrostat Current Sponsor code: LCI699 Concentration unit: mg milligram(s) Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Currently participating in a Global Novartis-sponsored osilodrostat study 2. Currently benefiting from treatment with osilodrostat, as determined by the Investigator 3. Demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements 4. Willingness and ability to comply with scheduled visits and treatment plans 5. Written informed consent obtained prior to enrolling into the roll-over study Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study 2. Receiving osilodrostat in combination with unapproved or experimental treatments for any type of endogenous CS 3. Pregnant or nursing women 4. Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 1 week after stopping medication

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate long-term safety data based on frequency and severity of AEs/SAEs;Secondary Objective: To evaluate clinical benefit as assessed by the Investigator To evaluate long term safety data based on laboratory evaluations, vital signs , ECG and pituitary MRI;Primary end point(s): Frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: Throughout the trial	—

Measure

Time frame

Main Objective: To evaluate long-term safety data based on frequency and severity of AEs/SAEs;Secondary Objective: To evaluate clinical benefit as assessed by the Investigator To evaluate long term safety data based on laboratory evaluations, vital signs , ECG and pituitary MRI;Primary end point(s): Frequency and severity of AEs/SAEs;Timepoint(s) of evaluation of this end point: Throughout the trial

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits Frequency, severity and summaries of relevant safety assessments, including : laboratory evaluations, vital signs (blood pressure and body weight), ECG and pituitary MRI.;Timepoint(s) of evaluation of this end point: Throughout the trial	—

Countries

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, China, Costa Rica, France, Germany, India, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Spain, Thailand, Turkey, United States

Contacts

Public ContactClinical Trial Information Desk

Recordati AG

clinicaltrials.endocrinology@recordati.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026