Clinical trial • Phase II/III • Endocrinology|Rare Disease
relacorilant (CORT-125134) for Endogenous Cushing syndrome
Phase II/III trial of relacorilant (CORT-125134) for Endogenous Cushing syndrome. open-label, none/not specified-controlled. 63 participants.
Overview
- Trial Therapeutic Area
- Endocrinology|Rare Disease
- Trial Disease
- Endogenous Cushing syndrome
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 08-08-2024
- First CTIS Authorization Date
- 05-09-2024
Trial design
open-label, none/not specified-controlled Phase II/III trial across 24 sites in Austria, Bulgaria, Germany and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 63
Eligibility
Recruits 63 Vulnerable population selected (isVulnerablePopulationSelected=true). Participants must provide written informed consent. No details on assent or parental/guardian consent for minors are provided in the available documents..
- Pregnancy Exclusion
- Female who is pregnant or lactating.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true). Participants must provide written informed consent. No details on assent or parental/guardian consent for minors are provided in the available documents.
Inclusion criteria
- {"criterion_text":"- Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome.\n- According to Investigator's opinion will benefit from treatment with relacorilant.\n- Provide written informed consent.\n- 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.\n- Are willing to continue to refrain from using drugs that inhibit steroid biosynthesis by the adrenal cortex or ACTH secretion by a pituitary or extra pituitary ACTH secreting tumor.\n- Are able to return to the investigative site to complete the study evaluations outlined in the protocol.\n- For patients with Cushing syndrome due to an ACTH-secreting pituitary tumor, are able to obtain pituitary MRI imaging (up to 6 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.\n- For patients entering the study >12 weeks after completing the last dose in the parent study, confirmation of hypercortisolism consistent with the criteria of the parent study is required.\n- For patients who received treatment for hypercortisolism after their last dose in the parent study, confirmation of hypercortisolism consistent with the criteria of the parent study is required."}
Exclusion criteria
- {"criterion_text":"- Have been prematurely discontinued from relacorilant study treatment in the parent study for any reason.\n- Have renal failure as defined by a serum creatinine of ≥2.2 mg/dL.\n- Have elevated total bilirubin >1.5 × the ULN or elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × ULN.\n- 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.\n- 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.\n- Has received stereotactic radiation therapy for a Cushing syndromerelated tumor within 24 months of Baseline or conventional pituitary radiation therapy within 36 months of Baseline.\n- Has undergone pituitary surgery <3 months prior to Screening.\n- Has plans for adrenalectomy or nodulectomy during the study, including follow-up.\n- Female who is pregnant or lactating.\n- Have an ongoing SAE that started in the parent study.\n- Are planning to start another Cushing syndrome drug after starting participation in this extension study.\n- Have an acute or unstable medical problem that could be aggravated by relacorilant treatment or has known active COVID-19 infection at Screening.\n- 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, osilodrostat, 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. • Patients who require inhaled glucocorticoid use and have no alternative option if their condition deteriorates during the study. • Mifepristone, from 4 weeks before Day 1. • Ongoing use of any strong CYP3A inducers during treatment with relacorilant. • Has used mitotane 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.\n- Plans for prolonged regular use of systemic glucocorticoids from Day 1 through the end of the study.\n- Have received investigational treatment (drug, biological agent, or device) other than relacorilant within 4 weeks of study entry, or within 5 times the drug's half-life, whichever is longer.\n- Have a history of an allergic reaction or intolerance to relacorilant.\n- Have uncorrected clinically significant hypokalemia (potassium level of < 3 mEq/L) within 2 weeks before enrollment in this study (Day 1).\n- Have uncontrolled, clinically significant hypothyroidism or hyperthyroidism."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Incidence of treatment-emergent adverse events (TEAEs) (assessed monthly): TEAEs, serious TEAEs (SAEs), treatment-related TEAEs, TEAEs leading to early discontinuation of study treatment.\n- Changes from Baseline in clinical laboratory tests (hematology and chemistry panels).\n- Changes from Baseline in physical examinations and vital sign measurements.\n- Changes from Baseline in electrocardiograms (ECGs) (12-lead) (including QTcF interval, QRS complex, PR interval, and heart rate).\n- Changes from Baseline in pituitary tumors based on magnetic resonance imaging (MRI) scans in patients with Cushing disease.","definition_or_measurement_approach":"Incidence of TEAEs: assessed monthly and includes TEAEs, SAEs, treatment-related TEAEs, and TEAEs leading to early discontinuation. Clinical laboratory changes: measured as changes from Baseline in hematology and chemistry panels. Physical exams and vital signs: measured as changes from Baseline in scheduled physical examinations and vital sign measurements. ECGs: 12-lead ECGs with assessment of QTcF, QRS, PR intervals, and heart rate (changes from Baseline). Pituitary tumor changes: assessed by MRI scans comparing tumor size/characteristics from Baseline."}
Recruitment
- Planned Sample Size
- 63
- Recruitment Window Months
- 90
- Consent Approach
- Written informed consent is required from participants. Subject information and informed consent forms (SIS/ICF) are uploaded for participating countries (multiple country-specific ICF documents/versions are present). No specific information on assent or parental/guardian consent for minors is provided in the available documents.
Geography
- Total Number Of Sites
- 24
- Total Number Of Participants
- 76
Austria
- Latest Decision Or Authorization Date
- 20-10-2024
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Medicine III (Division of Endocrinology and Metabolism)
- Principal Investigator Name
- Alexandra Kautzky-Willer
- Principal Investigator Email
- alexandra.kautzky-willer@meduniwien.ac.at
- Contact Person Name
- Alexandra Kautzky-Willer
- Contact Person Email
- alexandra.kautzky-willer@meduniwien.ac.at
Bulgaria
- Latest Decision Or Authorization Date
- 13-09-2024
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
- Department Name
- First clinic
- Principal Investigator Name
- Atanaska Elenkova
- Principal Investigator Email
- atanaskae@gmail.com
- Contact Person Name
- Atanaska Elenkova
- Contact Person Email
- atanaskae@gmail.com
Germany
- Latest Decision Or Authorization Date
- 26-09-2024
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Leipzig AöR
- Department Name
- Klinik und Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
- Principal Investigator Name
- Anke Tönjes
- Principal Investigator Email
- anke.toenjes@medizin.uni-leipzig.de
- Contact Person Name
- Anke Tönjes
- Contact Person Email
- anke.toenjes@medizin.uni-leipzig.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik IV
- Principal Investigator Name
- Martin Reincke
- Principal Investigator Email
- martin.reincke@med.uni-muenchen.de
- Contact Person Name
- Martin Reincke
- Contact Person Email
- martin.reincke@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Lehrstuhl für Endokrinologie
- Principal Investigator Name
- Ulrich Dischinger
- Principal Investigator Email
- dischinger_u@ukw.de
- Contact Person Name
- Ulrich Dischinger
- Contact Person Email
- dischinger_u@ukw.de
Romania
- Latest Decision Or Authorization Date
- 07-10-2024
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- National Institute Of Endocrinology C.I. Parhon
- Department Name
- Sectia Clinica Patologie Tiroidiana de Corelatie
- Principal Investigator Name
- Corin Badiu
- Principal Investigator Email
- contact@parhon.ro
- Contact Person Name
- Corin Badiu
- Contact Person Email
- contact@parhon.ro
- Site Name
- National Institute Of Endocrinology C.I. Parhon
- Department Name
- Sectia de Patologie Hipofizara si Neuroendocrina
- Principal Investigator Name
- Dan-Alexandru Niculescu
- Principal Investigator Email
- contact@parhon.ro
- Contact Person Name
- Dan-Alexandru Niculescu
- Contact Person Email
- contact@parhon.ro
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Sectia Endocrinologie
- Principal Investigator Name
- Aurelian-Emil Ranetti
- Principal Investigator Email
- secretariat@scumc.ro
- Contact Person Name
- Aurelian-Emil Ranetti
- Contact Person Email
- secretariat@scumc.ro
Spain
- Latest Decision Or Authorization Date
- 06-09-2024
- Number Of Sites
- 5
- Number Of Participants
- 10
Sites
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Endocrinology
- Principal Investigator Name
- Miguel Angel Mangas-Cruz
- Principal Investigator Email
- mangel.mangas.sspa@juntadeandalucia.es
- Contact Person Name
- Miguel Angel Mangas-Cruz
- Contact Person Email
- mangel.mangas.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Endocrinology
- Principal Investigator Name
- Francisco Jose Tinahones Madueno
- Principal Investigator Email
- fjtinahones@hotmail.com
- Contact Person Name
- Francisco Jose Tinahones Madueno
- Contact Person Email
- fjtinahones@hotmail.com
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Endocrinology
- Principal Investigator Name
- Antonio Miguel Pico Alfonso
- Principal Investigator Email
- antonio.pico@umh.es
- Contact Person Name
- Antonio Miguel Pico Alfonso
- Contact Person Email
- antonio.pico@umh.es
- Site Name
- Hospital Universitari De Girona Doctor Josep Trueta
- Department Name
- Endocrinology
- Principal Investigator Name
- Monica Recasens Sala
- Principal Investigator Email
- uden.mrecasens@htrueta.scs.es
- Contact Person Name
- Monica Recasens Sala
- Contact Person Email
- uden.mrecasens@htrueta.scs.es
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Endocrinology
- Principal Investigator Name
- Rogelio Garcia Centeno
- Principal Investigator Email
- rogelio.garcia@salud.madrid.org
- Contact Person Name
- Rogelio Garcia Centeno
- Contact Person Email
- rogelio.garcia@salud.madrid.org
Netherlands
- Latest Decision Or Authorization Date
- 05-09-2024
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Internal Medicine
- Principal Investigator Name
- Richard Feelders
- Principal Investigator Email
- r.feelders@erasmusmc.nl
- Contact Person Name
- Richard Feelders
- Contact Person Email
- r.feelders@erasmusmc.nl
Poland
- Latest Decision Or Authorization Date
- 13-10-2024
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddział Kliniczny Endokrynologii
- Principal Investigator Name
- Aleksandra Gilis-Januszewska
- Principal Investigator Email
- myjanusz@cyfronet.pl
- Contact Person Name
- Aleksandra Gilis-Januszewska
- Contact Person Email
- myjanusz@cyfronet.pl
- Site Name
- Pro Life Medica Sp. z o.o.
- Principal Investigator Name
- Iwona Chmiel-Perzynska
- Principal Investigator Email
- p.sobczak@etg-network.com
- Contact Person Name
- Iwona Chmiel-Perzynska
- Contact Person Email
- p.sobczak@etg-network.com
Italy
- Latest Decision Or Authorization Date
- 11-09-2024
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Istituto Auxologico Italiano
- Department Name
- U.O. Endocrinologia e Malattie del Metabolismo
- Principal Investigator Name
- Valentina Morelli
- Principal Investigator Email
- v.morelli@auxologico.it
- Contact Person Name
- Valentina Morelli
- Contact Person Email
- v.morelli@auxologico.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- SOD di Endocrinologia e Malattie del metabolismo
- Principal Investigator Name
- Marianna Martino
- Principal Investigator Email
- marianna.martino@ospedaliriuniti.marche.it
- Contact Person Name
- Marianna Martino
- Contact Person Email
- marianna.martino@ospedaliriuniti.marche.it
- Site Name
- Azienda Ospedaliera Universitaria Gaetano Martino Messina
- Department Name
- UO Endocrinologia
- Principal Investigator Name
- Salvatore Cannavo
- Principal Investigator Email
- cannavos@unime.it
- Contact Person Name
- Salvatore Cannavo
- Contact Person Email
- cannavos@unime.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- U.O.C. Endocrinologia
- Principal Investigator Name
- Antonio Stigliano
- Principal Investigator Email
- antonio.stigliano@uniroma1.it
- Contact Person Name
- Antonio Stigliano
- Contact Person Email
- antonio.stigliano@uniroma1.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Dip. Scienze Cliniche e Biologiche, Medicina Interna I ad indirizzo endocrinologico
- Principal Investigator Name
- Massimo Terzolo
- Principal Investigator Email
- massimo.terzolo@unito.it
- Contact Person Name
- Massimo Terzolo
- Contact Person Email
- massimo.terzolo@unito.it
- Site Name
- Azienda Ospedaliero-Universitaria Federico II Di Napoli
- Department Name
- Dipartimento di Medicina Clinica e Chirurgia
- Principal Investigator Name
- Rosario Pivonello
- Principal Investigator Email
- rosario.pivonello@unina.it
- Contact Person Name
- Rosario Pivonello
- Contact Person Email
- rosario.pivonello@unina.it
- Site Name
- Universita Degli Studi Di Padova
- Department Name
- U.O. Endocrinologia Dipartimento di Medicina
- Principal Investigator Name
- Filippo Ceccato
- Principal Investigator Email
- filippo.ceccato@unipd.it
- Contact Person Name
- Filippo Ceccato
- Contact Person Email
- filippo.ceccato@unipd.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Medicina Interna, Scienze Endocrino-metaboliche e Malattie Infettive
- Principal Investigator Name
- Andrea Isidori
- Principal Investigator Email
- andrea.isidori@uniroma1.it
- Contact Person Name
- Andrea Isidori
- Contact Person Email
- andrea.isidori@uniroma1.it
Sponsor
Primary sponsor
- Full Name
- Corcept Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 10, 6
- Name
- Icon (Lr) Limited
- Responsibilities
- sponsorDuties codes: 1, 12, 2, 4
- Name
- Suvoda LLC
- Responsibilities
- Randomization and Trial Supply Management
- Name
- Eresearchtechnology Inc.
- Responsibilities
- sponsorDuties codes: 4, 5, 6
- Name
- Fortrea Development Limited
- Responsibilities
- sponsorDuties code 8
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 10, 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Randomization and Trial Supply Management; sponsorDuties code 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"sponsorDuties codes: 4, 5, 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mayo Collaborative Services LLC","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Photograph Capture","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon (Lr) Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 2, 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Biomarker Assessment","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Fortrea Development Limited","duties_or_roles":"sponsorDuties code 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"sponsorDuties code 4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Relacorilant (sponsorProductCode: relacorilant; productOtherName: CORT125134)
- Active Substance
- relacorilant (CORT-125134)
- Modality
- Small molecule
- Authorisation Status
- EU product number PRD7037103 (prodAuthStatus: 1)
- Orphan Designation
- Yes
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