NCT03604198

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

Detailed description

This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment. Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.

Conditions

• Cushing Syndrome

Interventions

Type	Name	Description
DRUG	relacorilant	CORT125134 is supplied as capsules for oral dosing.

Timeline

• Start date: 2018-05-07
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2018-07-27
• Last updated: 2026-02-19

Locations

48 sites across 10 countries: United States, Austria, Canada, Germany, Israel, Italy, Netherlands, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study