Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
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|ClinicalTrials.gov Identifier: NCT03604198|
Recruitment Status : Enrolling by invitation
First Posted : July 27, 2018
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cushing Syndrome||Drug: relacorilant||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension Study of the Safety of Relacorilant in the Treatment of the Signs and Symptoms of Cushing Syndrome|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
|Experimental: relacorilant (CORT125134)||
CORT125134 is supplied as capsules for oral dosing.
Other Name: CORT125134
- Long-term safety of relacorilant [ Time Frame: 36 months ]Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0
- Long-term benefit of relacorilant [ Time Frame: 36 months ]Changes from Baseline as measured by glycated hemoglobin(HbA1c) and insulin resistance in patients with diabetes mellitus (DM) or glucose intolerance at Baseline in the parent study
- Long-term benefit of relacorilant [ Time Frame: 36 months ]Changes from Baseline as measured by systolic and diastolic blood pressure (BP) by ambulatory BP measurements (ABPM) in patients with uncontrolled hypertension (HTN) at Baseline in the parent study and in patients with controlled HTN taking at least one anti-HTN medication.
- Long-term benefit of relacorilant [ Time Frame: 36 months ]Changes from Baseline in weight as measured by Kg
- Long-term benefit of relacorilant [ Time Frame: 36 months ]Changes from Baseline in waist circumference measured in cm
- Long-term benefit of relacorilant [ Time Frame: 36 months ]Changes from Baselinein quality-of-life based on Cushing quality of life questionnaire 0 (worst) to 100 (best)
- Long-term benefit of relacorilant [ Time Frame: 36 months ]Changes from Baseline in hypthalamic-pituitary-adrenal (HPA) axis markers (Plasma ACTH and Fasting Cortisol) and Sex steroid hormone (testosterone and estradiol)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604198
|Study Director:||Andreas G Moraitis, MD||Corcept Therapeutics|