Glucocorticoid Receptor Antagonism in the Treatment of Cushing Syndrome (GRACE): A Phase 3, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Study of the Efficacy and Safety of Relacorilant - CORT125134-455

Corcept Therapeutics Incorporated0 sites162 target enrollmentDecember 11, 2018

Overview

No summary available.

Registry

who.int

Start Date

December 11, 2018

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•To enroll in the study, each patient must meet the following key inclusion criteria:
•1\. Male or female, 18 to 80 years of age, inclusive
•2\. Has a confirmed biochemical diagnosis of endogenous Cushing syndrome based on the presence of at least 2 of the following:
•UFC \> upper limit of normal (ULN) in at least 2 complete 24\-hour tests within the screening window.
•Late\-night salivary cortisol \>ULN in at least 2 tests (using a salivette) within the screening window (Note: Test is not appropriate for night shift workers and cannot be used to evaluate eligibility)
•Lack of cortisol suppression (\>1\.8 µg/dL serum cortisol) on either 1\-mg overnight or 2\-mg 48\-hour dexamethasone suppression testing during Screening, or within 12 weeks before signing the informed consent
•3\. Has at least 2 of the following clinical signs and symptoms of Cushing syndrome:
•Bodily characteristics of a Cushingoid appearance (e.g., facial rubor, moon facies, dorsocervical fat pad, supraclavicular fat pad)
•Increased body weight or central obesity
•Proximal muscle weakness

•Patients who meet any of the following criteria will not be permitted entry to the study:
•1\. Has severe, uncontrolled hypertension (mean SBP \>170 mm Hg or mean DBP \>110 mg at Screening), based on 24\-hour ABPM
•2\. Has poorly controlled DM (HbA1c \>12% at Screening)
•3\. Has a known long term history of both hypertension and diabetes (defined as both hypertension and diabetes diagnosed \>10 years prior to the initial diagnosis of endogenous CS)
•4\. Has a history of cyclic Cushing's syndrome with fluctuating clinical manifestations.
•5\. Has DM Type 1\.
•6\. Has abnormal liver test results (total bilirubin \>1\.5×ULN or elevated alanine aminotransferase or aspartate aminotransferase \>3×ULN at
•7\. Has severe renal insufficiency (glomerular filtration rate \=29 mL/min at Baseline)
•8\. Has uncontrolled, clinically significant hypothyroidism or
•hyperthyroidism