ECE2023 Eposter Presentations Pituitary and Neuroendocrinology (234 abstracts)
An Open-Label Extension Study to Evaluate the Safety of Long-term Use of Relacorilant in Patients With Endogenous Cushing Syndrome
Corin Badiu 1 , Cary N. Mariash 2 , Alexandra Kautzky-Willer 3 , Gadi Shlomai 4 , Carmen Aresta 5 , Rosario Pivonello 6 , Ulrich Dischinger 7 , Irina Bancos 8 , Georgiana Dobri 9 , Amir Hamrahian 10 , Richard Auchus 11 , Richard Feelders 12 , Monica Recasens 13 , Iwona Chmiel-Perzynska 14 , Emily Pearson 15 , Andreas G. Moraitis 15 & Katherine Araque 15
1National Institute of Endocrinology, University of Medicine and Pharmacy, Bucharest, Romania; 2Indiana University Health, Indianapolis, United States; 3Internal Medicine III, Endocrinology and Metabolism, Medical University Vienna, Vienna, Austria; 4The Institute of Endocrinology, Diabetes and Metabolism, the Chaim Sheba Medical Center, IL, Ramat Gan, Israel; 5Istituto Auxologico Italiano IRCCS, Milan, Italy; 6Federico II University of Naples, Naples, Italy; 7University Hospital Würzburg, Germany, Division of Endocrinology and Diabetes, Würzburg, Germany; 8Mayo Clinic, Division of Endocrinology, Rochester, United States; 9Weill Cornell Medicine, New York, United States; 10Johns Hopkins University, Division of Endocrinology, Diabetes and Metabolism, Baltimore, United States; 11University of Michigan, Ann Arbor, United States; 12Erasmus Medical Center, Department of Internal Medicine, Division of Endocrinology, Rotterdam, Netherlands; 13Hospital Josep Trueta Girona, Girona, France; 14ETG Lublin, Lublin, Poland; 15Corcept Therapeutics, Menlo Park, United States
Cushing syndrome (CS) is a chronic and debilitating condition with high morbidity and mortality. Development of novel, safe, and effective pharmacologic therapies with improved risk-benefit profiles would enrich treatment options for patients. Relacorilant is a selective glucocorticoid receptor (GR) modulator that competitively antagonizes cortisol activity and, unlike the FDA-approved GR antagonist mifepristone, does not bind to the progesterone receptor. In a phase 2 study in patients with endogenous CS (NCT02804750), relacorilant treatment was associated with clinically meaningful improvements in hypertension and hyperglycemia without undesirable antiprogesterone effects or drug-induced hypokalemia (Pivonello et al. Front Endocrinol. 2021;12:662865). GRACE (NCT03697109) and GRADIENT (NCT04308590) are ongoing phase 3 trials of relacorilant in patients with endogenous CS and concurrent hypertension and/or hyperglycemia. This abstract presents the study design of the phase 2/3, single-arm, open-label extension study (NCT03604198; EudraCT 2018-001616-30) evaluating the long-term safety and therapeutic effect of prolonged GR modulation with relacorilant. Study participants must have successfully completed one of the parent studies of relacorilant (NCT02804750, NCT03697109, NCT04308590) and, in the investigator’s opinion, may benefit from further treatment. Biochemical entry criteria are consistent with the parent studies. For participants who completed relacorilant treatment >12 weeks before entering the extension study, reconfirmation of hypercortisolism is required. Participants receive daily relacorilant at the last dose received in their parent study unless dose modification is indicated by the investigator’s clinical judgment. For participants entering from a placebo-controlled study or if the last dose of relacorilant was >4 weeks before enrollment, the starting dose is 100 mg oral capsule once daily, titrated up to the maximum tolerated dose not to exceed 400 mg. Treatment continues until relacorilant is commercially or otherwise available or until the study is stopped by the sponsor.
Primary endpoints are the incidence of treatment-emergent adverse events and changes from baseline in:
• Clinical laboratory tests
• Physical examinations and vital signs
• 12-lead electrocardiograms
• Pituitary tumor size based on magnetic resonance imaging for participants with Cushing disease
Exploratory endpoints assess the long-term benefit of relacorilant in the treatment of signs and symptoms of endogenous CS, including changes from baseline in the parent study in hemoglobin A1C, impaired glucose tolerance, and blood pressure. Additional exploratory endpoints include changes from baseline in body weight and composition, quality of life, bone remodeling, and other metabolic covariates of interest. This study is currently open for enrollment at centers in Europe, Israel, and North America.
Article tools
My recent searches
My recently viewed abstracts
Authors
Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
© Bioscientifica 2024 |
Privacy policy |
Cookie settings
BiosciAbstracts
Bioscientifica Abstracts is the gateway to a series of products that provide a permanent, citable record of abstracts for biomedical and life science conferences.
Find out more