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

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03604198
Enrollment
125
Registered
2018-07-27
Start date
2018-05-07
Completion date
2026-12-01
Last updated
2026-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cushing Syndrome

Keywords

Cushing Syndrome, Cushing Disease, Cushing, Hypercortisolemia, Cushingoid, Type 2 Diabetes, Impaired Glucose Intolerance, Hypertension, Adrenal Corticotrophic Hormone (ACTH), Adrenocortical Carcinoma, Primary Pigmented Nodular Adrenal Disease (PPNAD), Moon Facies, Dorsocervical Fat Pad, Adrenal Adenoma, Adrenal Carcinoma, Adrenal Autonomy, Cortisol

Brief 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.

Detailed 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.

Interventions

CORT125134 is supplied as capsules for oral dosing.

Sponsors

Corcept Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Long-term safety of relacorilant36 monthsNumber of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0

Countries

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

Contacts

STUDY_DIRECTORYing Ru, MD, PhD

Corcept Therapeutics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026