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

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome

Conditions
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Cushing Syndrome

Intervention / Treatment
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* Drug: relacorilant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major Inclusion Criteria: Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome with at least 80% compliance with the dosing schedule. 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 Has poorly controlled hypertension Has Stage ≥ 4 renal failure
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: relacorilant (CORT125134)<br> | Drug: relacorilant<br>* CORT125134 is supplied as capsules for oral dosing.<br>* Other names: CORT125134;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety of relacorilant | Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0 | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cushing Syndrome, Cushing Disease, Cushing, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Moon Facies, Impaired Glucose Intolerance, Hypertension, Adrenal Corticotrophic Hormone (ACTH), Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol