NCT02697734

Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study With an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients With Cushing's Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to confirm efficacy and safety of osilodrostat for the treatment of patients with Cushing's disease who are candidates for medical therapy.

Detailed description

The study LCI699C2302 (LINC-4) is a multi-center, randomized, double-blind study to evaluate the safety and efficacy of osilodrostat in patients with Cushing's disease. Enrolled patients were initially randomized to either osilodrostat or placebo, in a 2:1 ratio, for a 12-week double-blind period (Period 1). Randomization was stratified by history of pituitary radiation. After Week 12, all patients received open-label osilodrostat until the end of the Core phase at Week 48 (Period 2). After Week 48, patients could join an optional 48 week extension period.

Conditions

• Cushing's Disease

Interventions

Type	Name	Description
DRUG	osilodrostat	In the form of filmcoated tablets for oral administration, in the following dose strengths: 1 mg, 5 mg, 10 mg, and 20 mg.
DRUG	osilodrostat Placebo	Matching Placebo in the form of filmcoated tablets for oral administration

Timeline

• Start date: 2016-10-03
• Primary completion: 2019-06-19
• Completion: 2020-12-31
• First posted: 2016-03-03
• Last updated: 2021-11-01
• Results posted: 2021-10-19

Locations

36 sites across 14 countries: United States, Belgium, Brazil, Canada, China, Costa Rica, Greece, Poland, Portugal, Russia, Spain, Switzerland, Thailand, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study