A non-interventional study to assess the long-term safety and efficacy of osilodrostat in patients with endogenous Cushing’s syndrome (LINC 6)

Study identification

• EU PAS number:
  EUPAS46496
• Study ID:
  46497
• Official title and acronym:
  A non-interventional study to assess the long-term safety and efficacy of osilodrostat in patients with endogenous Cushing’s syndrome (LINC 6)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  United States
• Study description:
  Osilodrostat received approval from the EMA on 9-Jan-2020 for the treatment of adult patients with endogenous Cushing’s syndrome (CS). FDA approval was achieved on 6-Mar-2020 for the treatment of adult patients with Cushing’s disease (CD) for whom pituitary surgery is not an option or has not been curative. The Japanese Ministry of Health, Labour and Welfare (MHLW) approved osilodrostat for the treatment of patients with endogenous Cushing’s syndrome for whom pituitary surgery is not an option or has not been curative on 24th March 2021. The clinical development programme of osilodrostat provided robust data on the efficacy and safety of the compound, at the same time, the management of patients with endogenous Cushing’s syndrome requires life-long treatment. Therefore, this non-interventional study will assess the long-term safety of osilodrostat. In addition, the long-term use will also be evaluated in non-CD CS patients.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Recordati

Hopital de la Conception - APHM Marseille, France, Hopital Larrey Toulouse, France, CHU de Nancy - Hôpital de Brabois Nancy, France, Groupement Hospitalier Sud - Hôpital Bicêtre Bicetre, France, Hôpital Cochin Paris, France, CHU Bordeaux - Hôpital Haut-Lévêque Pessac, France, Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel Bron, France, Hopital Claude Huriez - CHRU Lille Lille, France, CHU de Nantes-Hopital Laennec Nantes, France, Other hospitals in France, Germany, Italy and USA France, Germany, Italy, USA

Study timelines

Date when funding contract was signed

Actual: 22/12/2021

Study start date

Planned: 04/07/2022

Actual: 13/06/2022

Data analysis start date

Planned: 14/08/2028

Date of final study report

Planned: 31/05/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Recordati AG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable