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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
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

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.

Condition or disease Intervention/treatment Phase
Cushing Syndrome Drug: relacorilant Phase 2

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.

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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 : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: relacorilant (CORT125134) Drug: relacorilant
CORT125134 is supplied as capsules for oral dosing.
Other Name: CORT125134




Primary Outcome Measures :
  1. Long-term safety of relacorilant [ Time Frame: 36 months ]
    Number of participants with treatment-emergent adverse events (TEAEs)as assessed by CTCAE v4.0


Other Outcome Measures:
  1. 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

  2. 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.

  3. Long-term benefit of relacorilant [ Time Frame: 36 months ]
    Changes from Baseline in weight as measured by Kg

  4. Long-term benefit of relacorilant [ Time Frame: 36 months ]
    Changes from Baseline in waist circumference measured in cm

  5. 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)

  6. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Show Show 18 study locations
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Andreas G Moraitis, MD Corcept Therapeutics
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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: February 25, 2021
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
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
Additional relevant MeSH terms:
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Cushing Syndrome
Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases