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

Cushing Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03604198
• Other study ID #: CORT125134-452
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: May 7, 2018
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cushing Syndrome
• Syndrome

Intervention

Drug:
• relacorilant
CORT125134 is supplied as capsules for oral dosing.

Locations

Country	Name	City	State
Austria	Site 14	Wien
Bulgaria	Site 15	Sofia
Canada	Site 51	Nova Scotia
Germany	Site 16	Munich
Germany	Site 42	Wuerzburg
Israel	Site 20	Ramat Gan
Israel	Site 29	Tel Aviv
Italy	Site 40	Ancona
Italy	Site 44	Messina
Italy	Site 25	Milano
Italy	Site 21	Napoli
Italy	Site 48	Padova
Italy	Site 22	Roma
Italy	Site 23	Roma
Italy	Site 52	Torino
Netherlands	Site 33	Rotterdam
Poland	Site 47	Kraków
Poland	Site 45	Lublin
Romania	Site 28	Bucharest
Romania	Site 31	Bucuresti
Romania	Site 37	Bucuresti
Spain	Site 53	Alicante
Spain	Site 18	Girona
Spain	Site 17	Madrid
Spain	Site 38	Málaga
Spain	Site 19	Sevilla
United States	Site 6	Albany	New York
United States	Site 8	Ann Arbor	Michigan
United States	Site 10	Atlanta	Georgia
United States	Site 27	Baltimore	Maryland
United States	Site 9	Chicago	Illinois
United States	Site 43	Cleveland	Ohio
United States	Site 11	Dallas	Texas
United States	Site 7	El Paso	Texas
United States	Site 13	Fall River	Massachusetts
United States	Site 32	Fort Worth	Texas
United States	Site 12	Houston	Texas
United States	Site 1	Indianapolis	Indiana
United States	Site 34	Jackson	Mississippi
United States	Site 5	Metairie	Louisiana
United States	Site 50	Miami	Florida
United States	Site 24	New York	New York
United States	Site 41	Oklahoma City	Oklahoma
United States	Site 49	Phoenix	Arizona
United States	Site 46	Pittsburgh	Pennsylvania
United States	Site 36	Rochester	Minnesota
United States	Site 26	Spokane	Washington
United States	Site 35	Stanford	California
United States	Site 39	Torrance	California
United States	Site 4	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Canada,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long-term benefit of relacorilant	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	36 months
Other	Long-term benefit of relacorilant	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.	36 months
Other	Long-term benefit of relacorilant	Changes from Baseline in weight as measured by Kg	36 months
Other	Long-term benefit of relacorilant	Changes from Baseline in waist circumference measured in cm	36 months
Other	Long-term benefit of relacorilant	Changes from Baselinein quality-of-life based on Cushing quality of life questionnaire 0 (worst) to 100 (best)	36 months
Other	Long-term benefit of relacorilant	Changes from Baseline in hypthalamic-pituitary-adrenal (HPA) axis markers (Plasma ACTH and Fasting Cortisol) and Sex steroid hormone (testosterone and estradiol)	36 months
Primary	Long-term safety of relacorilant	Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0	36 months