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

NCT ID: NCT03604198

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2025-12-31

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.

Conditions

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Cushing Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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relacorilant (CORT125134)

Group Type EXPERIMENTAL

relacorilant

Intervention Type DRUG

CORT125134 is supplied as capsules for oral dosing.

Interventions

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relacorilant

CORT125134 is supplied as capsules for oral dosing.

Intervention Type DRUG

Other Intervention Names

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CORT125134

Eligibility Criteria

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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

* Premature discontinuation from a relacorilant parent study.
* Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
* Has poorly controlled hypertension
* Has Stage ≥ 4 renal failure
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corcept Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ying Ru, MD, PhD

Role: STUDY_DIRECTOR

Corcept Therapeutics

Locations

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Site 49

Phoenix, Arizona, United States

Site Status

Site 35

Stanford, California, United States

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Site 39

Torrance, California, United States

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Site 50

Miami, Florida, United States

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Site 10

Atlanta, Georgia, United States

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Site 9

Chicago, Illinois, United States

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Site 1

Indianapolis, Indiana, United States

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Site 5

Metairie, Louisiana, United States

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Site 27

Baltimore, Maryland, United States

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Site 13

Fall River, Massachusetts, United States

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Site 8

Ann Arbor, Michigan, United States

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Site 36

Rochester, Minnesota, United States

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Site 34

Jackson, Mississippi, United States

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Site 3

St Louis, Missouri, United States

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Site 55

Reno, Nevada, United States

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Site 6

Albany, New York, United States

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Site 24

New York, New York, United States

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Site 4

Wilmington, North Carolina, United States

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Site 43

Cleveland, Ohio, United States

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Site 2

Pittsburgh, Pennsylvania, United States

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Site 46

Pittsburgh, Pennsylvania, United States

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Site 11

Dallas, Texas, United States

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Site 7

El Paso, Texas, United States

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Site 32

Fort Worth, Texas, United States

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Site 12

Houston, Texas, United States

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Site 14

Vienna, , Austria

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Site 51

Nova Scotia, , Canada

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Site 16

Munich, , Germany

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Site 42

Würzburg, , Germany

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Site 20

Ramat Gan, , Israel

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Site 29

Tel Aviv, , Israel

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Site 40

Ancona, , Italy

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Site 44

Messina, , Italy

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Site 25

Milan, , Italy

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Site 21

Napoli, , Italy

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Site 48

Padua, , Italy

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Site 52

Torino, , Italy

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Site 33

Rotterdam, , Netherlands

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Site 47

Krakow, , Poland

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Site 45

Lublin, , Poland

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Site 37

Bucharest, , Romania

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Site 31

Bucharest, , Romania

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Site 28

Bucharest, , Romania

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Site 53

Alicante, , Spain

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Site 18

Girona, , Spain

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Site 17

Madrid, , Spain

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Site 38

Málaga, , Spain

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Site 19

Seville, , Spain

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Countries

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United States Austria Canada Germany Israel Italy Netherlands Poland Romania Spain

Other Identifiers

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CORT125134-452

Identifier Type: -

Identifier Source: org_study_id

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