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    Summary
    EudraCT Number:2018-001616-30
    Sponsor's Protocol Code Number:CORT125134-452
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-01-10
    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 ConcernedSpain - AEMPS
    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
    Estudio de extensión sin enmascaramiento de la seguridad de relacorilant (CORT125134) en el tratamiento de los signos y síntomas del síndrome de Cushing endógeno
    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
    Extensión de un ensayo clinico para demostrar la seguridad de un estudio con medicamentos denominado (CORT125134) en el tratamiento del síndrome de Cushing
    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+1650327-3270
    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, soft
    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 number100
    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
    Síndrome de Cushing endógeno
    E.1.1.1Medical condition in easily understood language
    Cushing Syndrome caused by the body producing more cortisol than it needs.
    Síndrome de Cushing causado por el cuerpo al producir más cortisol del que necesita.
    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
    Evaluar la seguridad a largo plazo del relacorilant en el tratamiento de los signos y síntomas del síndrome de Cushing endógeno.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome.
    2. According to Investigator’s opinion will benefit from 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 28 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 28 days after the last dose of study drug. Highly effective methods of contraception are detailed in the protocol.
    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.
    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 (up to 3 months before starting treatment in this study, or up to 6 weeks after start of treatment in this study) to assess changes in tumor size during dosing. A CT scan can be used instead in patients for whom MRI is contraindicated.
    8. Patients who enter study >8 weeks after last dose in the parent study have active disease.
    1. Haber finalizado un estudio patrocinado por Corcept sobre relacorilant para el síndrome de Cushing endógeno.
    2. Pacientes que, en opinión del investigador, se vayan a beneficiar del tratamiento con relacorilant.
    3. Proporcionar el consentimiento informado por escrito.
    4. En el caso de mujeres con capacidad de concebir, las pacientes deben estar dispuestas a utilizar un método anticonceptivo muy eficaz desde los 30 días anteriores a la entrada en el estudio hasta los 28 días posteriores a la última dosis del fármaco del estudio. Los pacientes varones con una pareja de sexo femenino deben aceptar utilizar 2 métodos anticonceptivos, de los cuales uno debe ser un método de barrera doble, desde la entrada en el estudio hasta los 28 días posteriores a la última dosis del fármaco del estudio (sección 4.6.2). Los métodos
    anticonceptivos muy eficaces se enumeran en la sección 4.6.2.
    5. Estar dispuestos a continuar absteniéndose de usar fármacos que inhiban la biosíntesis esteroidea que realiza la corteza suprarrenal o la secreción de ACTH producida por un tumor hipofisario o extrahipofisario excretor de ACTH.
    6. Estar dispuestos a acudir al centro de investigación para llevar a cabo las evaluaciones del estudio que se especifican en el protocolo.
    7. En el caso de los pacientes con síndrome de Cushing debido a un tumor hipofisario excretor de ACTH, poder obtener imágenes mediante RM de la hipófisis (hasta un máximo de 3 meses antes del inicio del tratamiento en este estudio, o hasta 6 semanas después del inicio del
    tratamiento en este estudio; sección 6.7.5) para evaluar los cambios en el tamaño del tumor durante la administración de la dosis. En los pacientes en los que esté contraindicada la RM se puede realizar una exploración por TAC en su lugar.
    8. Los pacientes que entren en el estudio >8 semanas después de la administración de la última dosis del estudio principal deben tener la enfermedad activa.
    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 4 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.
    • Ongoing use of any strong CYP3A4 inhibitors (including grapefruit, grapefruit juice, or grapefruit-containing products) or inducers during treatment with relacorilant.
    • Mitotane, from 3 months prior to Day 1.
    • Ongoing use of antidiabetic, antihypertensive, antidepressant, and/or lipid-lowering medications that are highly dependent on CYP3A for clearance and that cannot undergo dose modifications upon coadministration with strong CYP3A inhibitors.
    5. Plan to use systemic or potent (Group III) 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) of >450 ms for males and >470 ms for females in the presence of a normal QRS interval (QRS <120 ms), a QTcF interval >500 ms with a wide QRS interval (≥120 ms),or a history of additional risk factors for torsades de pointes.
    14. Female who is pregnant or lactating.
    15. Have an ongoing SAE that started in the parent study.
    1. Haber interrumpido de forma prematura el tratamiento del estudio con relacorilant en el estudio principal por cualquier motivo.
    2. Estar pensando en iniciar un tratamiento con otro fármaco para el síndrome de Cushing después de comenzar la participación en este estudio de extensión.
    3. Padecer un problema médico agudo o inestable que podría agravarse con el tratamiento con relacorilant.
    4. Estar tomando los siguientes medicamentos desde los momentos especificados a continuación antes de la visita del día 1 del estudio CORT125134-452 y/o a lo largo de todo el periodo del estudio:
    • Los medicamentos utilizados en el tratamiento del síndrome de Cushing, con la excepción de relacorilant, están prohibidos:
    – medicamentos adrenostáticos: metirapona, ketoconazol, fluconazol, aminoglutetimida o etomidato 4 semanas antes del día 1 hasta el final de este estudio;
    – neuromoduladores que actúan a nivel del eje hipotálamo-hipofisario: antagonistas de la serotonina (ciproheptadina, ketanserina, ritanserina), agonistas de la dopamina (bromocriptina, cabergolina), agonistas del ácido γ-aminobutírico (valproato sódico) y ligandos del receptor de somatostatina (octreotida de acción prolongada [AP], pasireotida AP, lanreotida) desde las 8 semanas anteriores al día 1 hasta el final de este
    estudio. Uso de análogos de la somatostatina de acción corta (octreotida, pasireotida) desde las 4 semanas anteriores al día 1 hasta el final de este estudio.
    • Mifepristona, desde las 4 semanas anteriores al día 1.
    • Uso en curso de cualquier inhibidor (incluidos el pomelo, el zumo de pomelo o los productos que contengan pomelo) o inductor potente del CYP3A4 durante el tratamiento con relacorilant.
    • Mitotano, desde los 3 meses anteriores al día 1.
    • Uso en curso de antidiabéticos, antihipertensores, antidepresivos y/o hipolipemiantes que dependan en gran medida del CYP3A para el aclaramiento y que no puedan someterse a modificaciones de la dosis tras la administración conjunta con inhibidores potentes del
    CYP3A.
    5. Prever usar corticoesteroides sistémicos o intraarticulares potentes (grupo III) desde el día 1 hasta el final de este estudio.
    6. Haber recibido un tratamiento en fase de investigación (fármaco, agente biológico o dispositivo) distinto a relacorilant en las 4 semanas previas a la entrada en el estudio.
    7. Tener antecedentes de reacciones alérgicas o intolerancia a relacorilant.
    8. Tener hipopotasiemia no corregida (niveles de potasio <3,5 mEq/l) en las 2 semanas anterioresa la inclusión en este estudio (día 1).
    9. Tener hipotiroidismo o hipertiroidismo clínicamente significativo no controlado.
    10. Tener insuficiencia renal definida por niveles de creatinina sérica ≥2,2 mg/dl.
    11. Tener una elevación de la bilirrubina total >1,5 × el LSN o un aumento de la alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) ≥3 × LSN.
    12. Tener una anomalía clínicamente significativa en el ECG al inicio que, en opinión del investigador, hace que el paciente no sea un candidato apto para el estudio.
    13. Tener un intervalo QT inicial confirmado corregido mediante la fórmula de Fridericia (QTcF)
    >450 ms en el caso de los hombres y >470 ms en el caso de las mujeres en presencia de un intervalo QRS normal (QRS <120 ms), un intervalo QTcF >500 ms con un amplio intervalo QRS (≥120 ms) o antecedentes de factores de riesgo adicionales de taquicardia ventricular helicoidal.
    14. Ser una mujer embarazada o en periodo de lactancia.
    15. Tener un AAG en curso que comenzó en el estudio principal.
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence of TEAEs
    • Changes from baseline 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.
    • Incidencia de AAST
    • Cambios con respecto al inicio en los resultados analíticos clínicos
    • Cambios con respecto al inicio en los resultados de las exploraciones físicas y la medición de las constantes vitales
    • Cambios con respecto al inicio en las variables del ECG
    • Cambios con respecto al inicio en los tumores de la pituitaria según las RM en pacientes con enfermedad de Cushing.
    E.5.1.1Timepoint(s) of evaluation of this end point
    • AEs: all visits
    • Physical examination, vital signs: screening, baseline, every 1, 3 and 6 months, End of Treatment (EoT) and follow-up (F/up). For patients requiring dose titration additionally at Weeks 2, 6, 10 and 14.
    •Clinical laboratory measurements: screening, baseline, every 3 & 6 months, EoT and F/up. For patients requiring dose titration additionally at Weeks 6, 10 and 14.
    •12-Lead ECG: Screening, baseline, EoT, F/up. For patients requiring dose titration additionally at Week 14.
    • Pituitary MRI scan: baseline (if applicable), every 6 months, EoT
    • EA: todas las visitas
    • Examen físico, signos vitales: detección, visita de referencia, cada 1, 3 y 6 meses, Fin del tratamiento (EoT) y seguimiento. Para pacientes que requieren titulación de dosis adicionalmente en las semanas 2, 6, 10 y 14.
    • Mediciones de laboratorio clínico: detección, línea de base, cada 3 y 6 meses, EoT y seguimiento. Para pacientes que requieren titulación de dosis adicionalmente en las semanas 6, 10 y 14.
    • ECG de 12 derivaciones: detección, línea de base, EoT, seguimiento. Para pacientes que requieren un ajuste de dosis adicionalmente en la semana 14.
    • Imagen de resonancia magnética hipofisaria: visita de referecia (si corresponde), cada 6 meses, FdE
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 No
    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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Austria
    Bulgaria
    Canada
    Germany
    Israel
    Italy
    Netherlands
    Poland
    Romania
    Spain
    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.
    De acuerdo con las regulaciones de la Unión Europea y la FDA, el final del estudio se define como la fecha del último contacto (visita, teléfono, correo electrónico) con cualquier paciente del estudio.
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 50
    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 Decision2020-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-12
    P. End of Trial
    P.End of Trial StatusOngoing
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