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Clinical Trials/NCT03604198
NCT03604198Active, not recruitingPhase 2

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

Corcept Therapeutics82 sites in 8 countries125 enrolledStarted: May 7, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Active, not recruiting
Enrollment
125
Locations
82
Primary Endpoint
Long-term safety of relacorilant

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
N/A
Intervention Model
Single group
Primary Purpose
Treatment
Masking
None (open label)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Major Inclusion Criteria:
    • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome
    • According to the Investigator's opinion will benefit from continuing treatment with relacorilant.

Exclusion Criteria

  • Major Exclusion Criteria:
    • Premature discontinuation from a relacorilant parent study
    • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.

Arms & Interventions

relacorilant (CORT125134)

Experimental

Intervention: relacorilant (Drug)

Outcomes

Primary Outcomes

Long-term safety of relacorilant

Time Frame: 36 months

Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (82)

Loading locations...

Identifiers

NCT ID
NCT03604198
Other Study IDs
CORT125134-452, 2024-514079-17-00

Dates

First Submitted
(8 years ago)
First Posted
(8 years ago)
Primary Completion
(in 2 months)
Study Completion
(in 2 months)
Last Verified
(2 months ago)
Last updated
(last month)

Regulatory & Sharing

FDA Regulated Drug
Yes
FDA Regulated Device
No
IPD Sharing Plan
No
Has Results
No

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