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    Summary
    EudraCT Number:2018-001616-30
    Sponsor's Protocol Code Number:CORT125134-452
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-05-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2018-001616-30
    A.3Full title of the trial
    An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Extension of a clinical trial to assess the safety of a study drug called "CORT125134" in the treatment of Cushing Syndrome
    A.4.1Sponsor's protocol code numberCORT125134-452
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCorcept Therapeutics Incorporated
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCorcept Therapeutics Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCorcept Therapeutics Incorporated
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street Address149 Commonwealth Drive
    B.5.3.2Town/ cityMenlo Park, California
    B.5.3.3Post code94025
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 650 327-3270
    B.5.6E-mailCorceptStudy452@corcept.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CORT125134
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRelacorilant
    D.3.9.1CAS number 1496510-51-0
    D.3.9.2Current sponsor codeCORT125134
    D.3.9.3Other descriptive name(R)-(1-(4-FLUOROPHENYL)-6-((1-METHYL-1H-PYRAZOL-4-YL)SULFONYL)-4,4A,5,6,7,8-HEXAHYDRO-1H-PYRAZOLO[3,4-G]ISOQUINOLIN-4A-YL)(4-(TRIFLUOROMETHYL)PYRIDIN-2-YL)METHANONE
    D.3.9.4EV Substance CodeSUB168996
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Endogenous Cushing Syndrome
    E.1.1.1Medical condition in easily understood language
    Cushing Syndrome caused by the body producing more cortisol than it needs
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10011657
    E.1.2Term Cushings syndrome
    E.1.2System Organ Class 100000004860
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety of relacorilant in the treatment of the signs and symptoms of endogenous Cushing syndrome
    E.2.2Secondary objectives of the trial
    To assess the long-term benefit of relacorilant in the treatment of signs and symptoms of endogenous Cushing syndrome
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All Patients
    1. Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome through the treatment period with at least 80% adherence with scheduled dosing and visits.
    2. According to Investigator’s opinion will benefit from continuing treatment with relacorilant.
    3. Provide written informed consent.
    4. If a female of childbearing potential, patients must be willing to use a highly effective method of contraception from 30 days before study entry until 30 days after the last dose of study drug. Male patients with a female partner must agree to 2 forms of contraception, one of which must be a double-barrier method, from study entry until 30 days after the last dose of study drug. Highly effective methods of contraception include abstinence, oral contraceptives combined with a barrier method, diaphragm with vaginal spermicide, intrauterine device, male condom and partner using vaginal spermicide, and surgical sterilization (≥6 months postsurgery).
    5. Are willing to continue to refrain from using drugs that inhibit steroid biosynthesis by the adrenal cortex or ACTH secretion by a pituitary or extrapituitary ACTH secreting tumor. Mitotane is acceptable in patients with adrenal carcinoma.
    6. Are able to return to the investigative site to complete the study evaluations outlined in the protocol.
    7. For patients with Cushing syndrome due to an ACTH-secreting pituitary tumor, are able to obtain pituitary MRI imaging (obtained up to 3 months before to 6 weeks after start of treatment in this study) to assess changes in tumor size during dosing.

    Patients Who Enter Study >8 Weeks After Completing the Parent Study
    8. Have a diagnosis of endogenous Cushing syndrome confirmed by 2 of the 3 following biochemical test criteria:
    • Urinary free cortisol above the upper limit of normal (ULN) (50.0 μg/24 h) in at least 2 complete 24-hour collections within 3 weeks before Day 1.
    • Late-night salivary cortisol above the ULN in at least 2 collections using a salivette within 3 weeks before Day 1.
    • Results from the dexamethasone suppression test performed during the parent study.
    Patients requiring washout of a medication for Cushing syndrome must complete the screening 24-hour UFC tests and salivary cortisol tests after a minimum washout of 2 weeks for adrenostatic medications and short-acting somatostatin analogs, 4 weeks for mifepristone and dopamine agonists, and 6 weeks for long-acting somatostatin ligands and within 3 weeks before Day 1 dosing.
    E.4Principal exclusion criteria
    1. Have been prematurely discontinued from relacorilant study treatment in the parent study for any reason
    2. Are planning to start another Cushing syndrome drug after starting participation in this extension study.
    3. Have an acute or unstable medical problem that could be aggravated by relacorilant treatment.
    4. Are taking the following medications from the times specified below before the Study CORT125134-452 Day 1 visit and/or through the entire study period:
    • Medications used in the treatment of Cushing syndrome, with the exception of relacorilant, are prohibited:
    – Adrenostatic medications: metyrapone, ketoconazole, fluconazole, aminoglutethimide, or etomidate 2 weeks before Day 1 through the end of this study
    – Neuromodulator drugs that act at the hypothalamic-pituitary level: serotonin antagonists (cyproheptadine, ketanserin, ritanserin), dopamine agonists (bromocriptine, cabergoline), gamma-aminobutyric acid agonists (sodium valproate), and somatostatin receptor ligands (octreotide long-acting release [LAR], pasireotide LAR, lanreotide) from 8 weeks before Day 1 through the end of this study. Use of short-acting somatostatin analogs (octreotide, pasireotide) from 4 weeks before Day 1 through the end of this study.
    • Mifepristone, from 4 weeks before Day 1 through the end of this study.
    • Strong CYP3A4 inhibitors (including grapefruit, grapefruit juice, or grapefruit-containing products) during treatment with relacorilant.
    5. Plan to use systemic, potent (Group III), and potent intra-articular corticosteroids from Day 1 through the end of the study.
    6. Have received investigational treatment (drug, biological agent, or device) other than relacorilant within 4 weeks of study entry.
    7. Have a history of an allergic reaction or intolerance to relacorilant.
    8. Have uncorrected hypokalemia (potassium level of < 3.5 mEq/L) within 2 weeks before enrollment in this study (Day 1).
    9. Have uncontrolled, clinically significant hypothyroidism or hyperthyroidism.
    10. Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.
    11. Have elevated total bilirubin >1.5 × the ULN or elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × ULN.
    12. Have a clinically significant ECG abnormality at baseline, which, in the opinion of the Investigator, will make the patient an unsuitable candidate for the study.
    13. Have a confirmed baseline QT interval corrected using Fridericia’s formula (QTcF) >450 ms for males and >470 ms for females in the presence of a normal QRS interval (QRS <120 ms) or a history of additional risk factors for torsades de pointes.
    14. Women of childbearing potential: are pregnant based on serum pregnancy test.
    15. Have an ongoing SAE that started in the parent study.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of TEAEs
    • Changes from baseline levels in clinical laboratory measurements
    • Changes from baseline in physical examinations and vital sign measurements
    • Changes from baseline in ECG variables
    • Changes from baseline in pituitary tumors based on MRI scans in patients with Cushing disease.
    • PK measurements
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly :
    - Incidence of TEAEs

    Every 3 and 12 Months and at End of Study:
    - Adverse event monitoring
    - Clinical laboratory measurements
    - Physical examination
    - Vital signs including BP, heart rate, respiratory rate, and oral body temperature
    - 12-Lead ECG
    - PK sampling

    Every 12 Months and at End of Study:
    - Pituitary MRI scan
    E.5.2Secondary end point(s)
    Changes from baseline in the following:
    - HbA1c and insulin resistance indices in patients with Diabetes mellitus or glucose intolerance if an oral glucose tolerance test (OGTT) was a key efficacy assessment in the parent study
    – BP by ambulatory BP measurements (ABPM) in patients with uncontrolled hypertension (HTN) if this was a key efficacy assessment in the parent study and in patients with controlled HTN taking at least one anti-HTN medication
    – Physician’s Global Assessment of Disease Severity
    – Weight and waist circumference
    – Quality-of-life (CushingQoL) questionnaire
    – Biochemical markers of bone remodeling
    – HPA axis markers
    – Cortisol concentration in blood, urine, and saliva
    – Lipid levels
    – Sex steroid hormone and gonadotropin levels
    – Menstrual cycle characterization (premenopausal women not taking hormonal contraceptive medication)
    – Thyroid function tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 3 and 12 Months and at End of Study:
    - HbA1c
    - ABPM
    - Physician’s Global Assessment
    - Weight and waist circumference
    - CushingQoL Questionnaire
    - Biochemical markers of bone remodeling
    - HPA axis parameters
    - Late-night salivary cortisol
    - Lipid panel (fasting)
    - Sex hormone levels
    - Menstrual cycle information

    - Thyroid function tests
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Hungary
    Italy
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    In accordance with European Union and FDA regulations, the end of study is defined as the date of last contact (visit, telephone, e-mail) with any study patient.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days18
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days18
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 75
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
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