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 |
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Recruitment Status :
Enrolling by invitation
First Posted : July 27, 2018
Last Update Posted : May 3, 2024
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| 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 |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 : | December 2025 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: relacorilant (CORT125134) |
Drug: relacorilant
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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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:
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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
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
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| Study Director: | Katherine Araque, MD, MSCR | Corcept Therapeutics |
| Responsible Party: | Corcept Therapeutics |
| ClinicalTrials.gov Identifier: | NCT03604198 |
| Other Study ID Numbers: |
CORT125134-452 |
| First Posted: | July 27, 2018 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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Cushing Syndrome Syndrome Disease Pathologic Processes |
Adrenocortical Hyperfunction Adrenal Gland Diseases Endocrine System Diseases |