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

• Register: EUCTR
• Last refreshed on: 7 January 2019
• Main ID: EUCTR2017-002840-34-ES
• Date of registration: 11/07/2018
• Prospective Registration: Yes
• Primary sponsor: Novartis Farmacéutica, S.A
• Public title: Roll-over study to assess long-term safety in patients with endogenous Cushing’s syndrome who have completed a prior Novartis-sponsored osilodrostat study
• Scientific title: 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
• Date of first enrolment: 31/10/2018
• Target sample size: 200
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-002840-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Trial Monitoring Organization (TMo)
• Affiliation: Novartis Farmacéutica, S.A

• Name: Trial Monitoring Organization (TMo)
• Affiliation: Novartis Farmacéutica, S.A

Key inclusion & exclusion 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? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Hormonal diseases [C19]

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

Intervention(s)

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)
Concentration type: equal
Concentration number: 1-

Product Name: osilodrostat 5mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Product Name: osilodrostat 10mg
Product Code: LCI699
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: osilodrostat
Current Sponsor code: LCI699
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Throughout the trial

Secondary Objective: To evaluate clinical benefit as assessed by the Investigator

Main Objective: To evaluate long-term safety data

Primary end point(s): Frequency and severity of AEs/SAEs

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: At each scheduled visit

Secondary end point(s): Proportion of patients with clinical benefit as assessed by the Investigator at scheduled visits

Secondary ID(s)

CLCI699C2X01B

2017-002840-34-AT

Source(s) of Monetary Support

Novartis Pharma AG